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(May 16, 2018)
NORTH CHICAGO, Ill., May 16, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced it will present data about the company's portfolio of investigational oncology medicines during the American Society of Clinical Oncology (ASCO) Annual Meeting, June 1-5, in Chicago. More than 30 abstracts have been accepted, featuring data in hematologic malignancies and several solid tumor types, including brain cancer and lung cancer.
Researchers will present data across multiple hematologic malignancies evaluating venetoclax, a first-in-class BCL-2 inhibitor developed by AbbVie and Genentech, and ibrutinib, an inhibitor of Bruton's tyrosine kinase (BTK).
Additionally, updated data will be featured from AbbVie's late-stage investigational products including depatuxizumab mafodotin (depatux-m; previously known as ABT-414), an antibody-drug conjugate (ADC), in amplified-epidermal growth factor receptor (EGFR) recurrent glioblastoma (rGBM); rovalpituzumab tesirine (Rova-T), an investigational ADC targeting delta-like protein 3 (DLL3)-expressing tumors, in small cell lung cancer (SCLC); veliparib, an investigational oral poly (adenosine diphosphate [ADP]–ribose) polymerase (PARP) inhibitor, across multiple solid tumors; elotuzumab, an immunostimulatory antibody that specifically targets signaling lymphocyte activation molecule family member 7 (SLAMF7), a cell-surface glycoprotein; as well as other early-stage investigational compounds, including ABBV-075 (Mivebresib), ABT-165 and PF-06647020 (PF-7020).
In oncology discovery and early development, AbbVie utilizes key therapeutic pathways and methods to identify appropriate options to treat people living with cancer. Abstracts at ASCO 2018 will also show progress in AbbVie's discovery and early development efforts.
"AbbVie's data at ASCO 2018 reinforces the potential of our robust oncology portfolio, focused on helping patients impacted by several different cancers where few durable treatment options exist," said Neil Gallagher, M.D., vice president and head of global oncology development, AbbVie. "We concentrate our efforts on delivering meaningful medicines for patients, and are committed to advancing science aimed at the most difficult-to-treat cancers."
To learn more about our work in oncology, visit http://abbvieoncology.com.
AbbVie abstracts include:
- Randomized Phase 3 Trial of Ibrutinib/Rituximab vs Placebo/Rituximab in Waldenström's macroglobulinemia; Dimopoulos et al.; Abstract 8003; Oral Abstract Session; Friday, June 1, 2018; 3:45 p.m.-3:57 p.m. CT
- Phase 2 CAPTIVATE Results of Ibrutinib (ibr) Plus Venetoclax (ven) in First-Line Chronic Lymphocytic Leukemia (CLL); Wierda et al.; Abstract 7502; Oral Abstract Session; Sunday, June 3, 2018; 10:09 a.m.-10:21 a.m. CT
- Phase 2 Study of Venetoclax Plus Carfilzomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma; Costa et al.; Abstract 8004; Oral Abstract Session; Friday, June 1, 2018; 3:57 p.m.-4:09 p.m. CT
- Open-Label, Dose-Escalation, Phase 1 Study of Venetoclax in Combination with Navitoclax and Chemotherapy in Patients with Relapsed Acute Lymphoblastic Leukemia; Alexander et al.; Abstract TPS10575; Poster Session; Saturday, June 2, 2018; 8:00 a.m.-11:30 a.m. CT
- High, Durable Minimal Residual Disease Negativity (MRD–) with Venetoclax + Rituximab (VenR) in Relapsed/Refractory (R/R) CLL: MRD Kinetics from Phase 3 MURANO Study; Hillmen et al.; Abstract 7508; Oral Abstract Session; Sunday, June 3, 2018; 11:57 a.m.-12:09 p.m. CT
- Phase 1b Study of Venetoclax in Combination with Azacitidine in Patients with Treatment-Naïve Higher-Risk Myelodysplastic Syndromes; Fong et al.; Abstract TPS7082; Poster Session; Monday, June 4, 2018; 8:00 a.m.-11:30 a.m. CT
- Management and Outcomes of 222 CLL Patients (pts) Treated with Venetoclax (VEN) in the Real World; Nabhan et al.; Abstract 7529; Poster Session; Monday, June 4, 2018; 8:00 a.m.-11:30 a.m. CT
- Mitigation of Tumor Lysis Syndrome (TLS) Complications with Venetoclax (VEN) in CLL; Davids et al.; Abstract 7526; Poster Session; Monday, June 4, 2018; 8:00 a.m.-11:30 a.m. CT
- A Phase 1/2, Multicenter, Dose-Escalation and Expansion Study of Combination Therapy with Venetoclax, Daratumumab, and Dexamethasone (with and without Bortezomib) in Subjects with Relapsed or Refractory Multiple Myeloma; Bueno et al.; Abstract TPS8061; Poster Session; Monday, June 4, 2018; 8:00 a.m.-11:30 a.m. CT
- Durability of Response to Venetoclax (VEN) in Patients with CLL Who are Refractory to or Relapsed After Ibrutinib and/or Idealisib; Byrd et al.; Abstract 7512; Poster Discussion Session; Monday, June 4, 2018; Poster 8:00 a.m.-11:30 a.m. CT; Discussion 1:15 p.m.-2:30 p.m. CT
- Durable Response with Venetoclax in Combination with Decitabine or Azacitadine in Elderly Patients with Acute Myeloid Leukemia (AML); Dinardo et al.; Abstract 7010; Clinical Science Symposium; Monday, June 4, 2018; 4:30 p.m.-6:00 p.m. CT
- Feasibility and Implementation of Geriatric Assessment Measures and Patient-Reported Outcomes in Acute Myeloid Leukemia; Klepin et al.; Publication only
Depatuxizumab mafodotin (depatux-m; ABT-414)
- Updated Results of the INTELLANCE 2/EORTC Trial 1410 Randomized Phase II Study on Depatux–M Alone, Depatux-M in Combination with Temozolomide (TMZ) and Either TMZ or Lomustine (LOM) in Recurrent EGFR Amplified Glioblastoma (NCT02343406); Van Den Bent et al.; Abstract 2023; Poster Session; Saturday, June 2, 2018; 1:15 p.m.-4:45 p.m. CT
- Effect of Therapeutic Pressure on Stability of EGFR Amplification in Glioblastoma; Ahluwalia et al.; Abstract 2033; Poster Session; Saturday, June 2, 2018; 1:15 p.m.-4:45 p.m. CT
Rovalpituzumab tesirine (Rova-T)
- Efficacy and Safety of Rovalpituzumab Tesirine in Patients with DLL3-Expressing, ? 3rd Line Small Cell Lung Cancer: Results from the Phase 2 TRINITY Study; Carbone et al.; Abstract 8507; Oral Abstract Session; Monday, June 4, 2018; 10:12 a.m.-10:24 a.m. CT
- Incidence of Pre-Treatment and Off-Treatment Pericardial and Pleural Effusions by Line of Therapy in Patients with Small Cell Lung Cancer: An Analysis of Electronic Health Records Data; Jiang et al.; Publication only
- Phase 2 Study of Veliparib Plus FOLFIRI ± Bevacizumab versus Placebo Plus FOLFIRI ± Bevacizumab in Metastatic Colorectal Cancer; Gorbunova et al.; Abstract 3543; Poster Session; Sunday, June 3, 2018; 8:00 a.m.-11:30 a.m. CT
- Veliparib in Combination with Nivolumab and Platinum Doublet Chemotherapy (CT) in Metastatic/Advanced NSCLC; Clarke et al.; Abstract 3061; Poster Session; Monday, June 4, 2018; 8:00 a.m.-11:30 a.m. CT
- Extended 5-y Follow-up (FU) of Phase 3 ELOQUENT-2 Study of Elotuzumab + Lenalidomide/Dexamethasone (ELd) vs Ld in Relapsed/Refractory Multiple Myeloma (RRMM); Lonial et al.; Abstract 8040; Poster Session; Monday, June 4, 2018; 8:00 a.m.-11:30 a.m. CT
- First-in-Human Study of ABBV-075 (mivebresib), a Pan-Inhibitor of Bromodomain and Extra Terminal (BET) Proteins, in Patients (pts) with Relapsed/Refractory (RR) Acute Myeloid Leukemia (AML): Preliminary Data; Borthakur et al.; Abstract 7019; Poster Discussion Session; Monday, June 4, 2018; Poster 8:00 a.m.-11:30 a.m. CT; Discussion 11:30 a.m.-12:45 p.m. CT
- Gene Expression and Cytokine Modulation in a First in Human (FIH) Study of a Pan BET Inhibitor ABBV-075 in Solid Tumors; O'Neil et al.; Abstract 2570; Poster Session; Monday, June 4, 2018; 8:00 a.m.-11:30 a.m. CT
- Results of the First-in-Human Study of ABBV-075 (mivebresib), a Pan-Inhibitor of Bromodomain (BD) and Extra Terminal (BET) Proteins, in Patients (pts) with Relapsed/Refractory (R/R) Solid Tumors; Piha-Paul et al.; Abstract 2510; Poster Discussion Session; Monday, June 4, 2018; Poster 8:00 a.m.-11:30 a.m. CT; Discussion 3:00 p.m.-4:15 p.m. CT
- Uveal Melanoma Treated with Pan-BET Inhibitor ABBV-075: Results from the Phase 1 M14-546 study; Patel et al.; Publication only
- ABT-165 Plus FOLFIRI vs Bevacizumab (bev) Plus FOLFIRI in Patients (pts) with Metastatic Colorectal Cancer (mCRC) Previously Treated with Fluoropyrimidine/Oxaliplatin and Bev; Wainberg et al.; Abstract TPS3619; Poster Session; Sunday, June 3, 2018; 8:00 a.m.-11:30 a.m. CT
- Correlation Between Gene Expression and Prognostic Biomarkers in Small Cell Bladder Cancer (SCBC); Koshkin et al.; Abstract 4546; Poster Session; Saturday, June 2, 2018; 8:00 a.m.-11:30 a.m. CT
Bromodomain and Extra-Terminal motif (BET) inhibitors
- Preclinical Evidence for Thrombocytopenia Associated with Bromodomain Extra-Terminal (BET) inhibition therapy; Mantena et al.; Publication only
- ICR Gene Signature to Identify Differential Immune Landscapes in Anatomic Subsites of Head and Neck Squamous Cell Carcinomas and Implications in Personalized Medicine; Pai et al.; Abstract 6052; Poster Session; Saturday, June 2, 2018; 1:15 p.m.-4:45 p.m. CT
- Clinical Pharmacology Assessment of PF-06647020 (PF-7020), an Antibody-Drug Conjugate (ADC) Targeting Protein Tyrosine Kinase 7 (PTK7), in Adult Patients (pts) with Advanced Solid Tumors; Xuan et al.; Abstract 2574; Poster Session; Monday, June 4, 2018; 8:00 a.m.-11:30 a.m. CT
- PF-06647020 (PF-7020), an Antibody-Drug Conjugate (ADC) Targeting Protein Tyrosine Kinase 7 (PTK7), in Patients (pts) with Advanced Solid Tumors: Results of a Phase I Dose Escalation and Expansion Study; Sachdev et al.; Abstract 5565; Poster Session; Monday, June 4, 2018; 1:15 p.m.-4:45 p.m. CT
The ASCO 2018 Annual Meeting abstracts are available at http://am.asco.org/abstracts.
These investigational agents and the approved drugs venetoclax, ibrutinib and elotuzmab are being studied for unapproved uses or regimens where safety and efficacy have not been established.
IMBRUVICA® (ibrutinib) is a first-in-class, oral, once-daily therapy that mainly works by blocking a protein called Bruton's tyrosine kinase (BTK). BTK is a key signaling molecule in the B-cell receptor signaling complex that plays an important role in the survival and spread of malignant B cells as well as other serious, debilitating conditions.1,2 IMBRUVICA blocks signals that tell malignant B cells to multiply and spread uncontrollably.1
IMBRUVICA has been granted four Breakthrough Therapy Designations from the FDA, including in cGVHD. This designation is intended to expedite the development and review of a potential new drug for serious or life-threatening diseases.3 IMBRUVICA was one of the first medicines to receive U.S. FDA approval via the new Breakthrough Therapy Designation pathway.
IMBRUVICA is FDA-approved in six distinct patient populations: chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), Waldenström's macroglobulinemia (WM), along with previously-treated mantle cell lymphoma (MCL), previously-treated marginal zone lymphoma (MZL) and previously-treated chronic graft-versus-host-disease (cGVHD).1
- IMBRUVICA was first approved for adult patients with MCL who have received at least one prior therapy in November 2013.
- Soon after, IMBRUVICA was initially approved in adult CLL patients who have received at least one prior therapy in February 2014. By July 2014, the therapy received approval for adult CLL patients with 17p deletion, and by March 2016, the therapy was approved as a frontline CLL treatment.
- IMBRUVICA was approved for adult patients with WM in January 2015.
- In May 2016, IMBRUVICA was approved in combination with bendamustine and rituximab (BR) for adult patients with previously treated CLL/SLL.
- In January 2017, IMBRUVICA was approved for adult patients with MZL who require systemic therapy and have received at least one prior anti-CD20-based therapy.
- In August 2017, IMBRUVICA was approved for adult patients with cGVHD that failed to respond to one or more lines of systemic therapy.
Accelerated approval was granted for the MCL and MZL indications based on overall response rate. Continued approval for MCL and MZL may be contingent upon verification and description of clinical benefit in confirmatory trials.1
IMBRUVICA is being studied alone and in combination with other treatments in several blood and solid tumor cancers and other serious illnesses. IMBRUVICA has one of the most robust clinical oncology development programs for a single molecule in the industry, with more than 130 ongoing clinical trials. There are approximately 30 ongoing company-sponsored trials, 14 of which are in Phase 3, and more than 100 investigator-sponsored trials and external collaborations that are active around the world. To date, 90,000 patients around the world have been treated with IMBRUVICA in clinical practice and clinical trials.
Patient Access to IMBRUVICA
AbbVie and Janssen strive to make access to IMBRUVICA easy by helping patients in the U.S. understand their insurance benefits for IMBRUVICA. The YOU&i™ Support Program is a program that includes information on access and affordability support options, nurse call support and resources for patients being treated with IMBRUVICA.
IMBRUVICA® (ibrutinib) U.S. IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Hemorrhage: Fatal bleeding events have occurred in patients treated with IMBRUVICA®. Grade 3 or higher bleeding events (intracranial hemorrhage [including subdural hematoma], gastrointestinal bleeding, hematuria, and post-procedural hemorrhage) have occurred in up to 6% of patients. Bleeding events of any grade, including bruising and petechiae, occurred in approximately half of patients treated with IMBRUVICA®.
The mechanism for the bleeding events is not well understood.
IMBRUVICA® may increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies and patients should be monitored for signs of bleeding.
Consider the benefit-risk of withholding IMBRUVICA® for at least 3 to 7 days pre and post-surgery depending upon the type of surgery and the risk of bleeding.
Infections: Fatal and non-fatal infections (including bacterial, viral, or fungal) have occurred with IMBRUVICA® therapy. Grade 3 or greater infections occurred in 14% to 29% of patients. Cases of progressive multifocal leukoencephalopathy (PML) and Pneumocystis jirovecii pneumonia (PJP) have occurred in patients treated with IMBRUVICA®. Consider prophylaxis according to standard of care in patients who are at increased risk for opportunistic infections.
Monitor and evaluate patients for fever and infections and treat appropriately.
Cytopenias: Treatment-emergent Grade 3 or 4 cytopenias including neutropenia (range, 13 to 29%), thrombocytopenia (range, 5 to 17%), and anemia (range, 0 to 13%) based on laboratory measurements occurred in patients with B-cell malignancies treated with single agent IMBRUVICA®.
Monitor complete blood counts monthly.
Cardiac Arrhythmias: Fatal and serious cardiac arrhythmias have occurred with IMBRUVICA® therapy. Grade 3 or greater ventricular tachyarrhythmias occurred in 0 to 1% of patients, and Grade 3 or greater atrial fibrillation and atrial flutter occurred in 0 to 6% of patients. These events have occurred particularly in patients with cardiac risk factors, hypertension, acute infections, and a previous history of cardiac arrhythmias.
Periodically monitor patients clinically for cardiac arrhythmias. Obtain an ECG for patients who develop arrhythmic symptoms (e.g., palpitations, lightheadedness, syncope, chest pain) or new onset dyspnea. Manage cardiac arrhythmias appropriately, and if it persists, consider the risks and benefits of IMBRUVICA® treatment and follow dose modification guidelines.
Hypertension: Hypertension (range, 6 to 17%) has occurred in patients treated with IMBRUVICA® with a median time to onset of 4.6 months (range, 0.03 to 22 months). Monitor patients for new onset hypertension or hypertension that is not adequately controlled after starting IMBRUVICA®.
Adjust existing anti-hypertensive medications and/or initiate anti-hypertensive treatment as appropriate.
Second Primary Malignancies: Other malignancies (range, 3 to 16%) including non-skin carcinomas (range, 1 to 4%) have occurred in patients treated with IMBRUVICA®. The most frequent second primary malignancy was non-melanoma skin cancer (range, 2 to 13%).
Tumor Lysis Syndrome: Tumor lysis syndrome has been infrequently reported with IMBRUVICA® therapy. Assess the baseline risk (e.g., high tumor burden) and take appropriate precautions.
Monitor patients closely and treat as appropriate.
Embryo-Fetal Toxicity: Based on findings in animals, IMBRUVICA® can cause fetal harm when administered to a pregnant woman. Advise women to avoid becoming pregnant while taking IMBRUVICA® and for 1 month after cessation of therapy. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Advise men to avoid fathering a child during the same time period.
B-cell malignancies: The most common adverse reactions (?20%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were thrombocytopenia (62%)*, neutropenia (61%)*, diarrhea (43%), anemia (41%)*, musculoskeletal pain (30%), bruising (30%), rash (30%), fatigue (29%), nausea (29%), hemorrhage (22%), and pyrexia (21%).
The most common Grade 3 or 4 adverse reactions (?5%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were neutropenia (39%)*, thrombocytopenia (16%)*, and pneumonia (10%).
Approximately 6% (CLL/SLL), 14% (MCL), 11% (WM) and 10% (MZL) of patients had a dose reduction due to adverse reactions. Approximately 4%-10% (CLL/SLL), 9% (MCL), and 9 % (WM [6%] and MZL [13%]) of patients discontinued due to adverse reactions.
cGVHD: The most common adverse reactions (?20%) in patients with cGVHD were fatigue (57%), bruising (40%), diarrhea (36%), thrombocytopenia (33%)*, stomatitis (29%), muscle spasms (29%), nausea (26%), hemorrhage (26%), anemia (24%)*, and pneumonia (21%).
The most common Grade 3 or 4 adverse reactions (?5%) reported in patients with cGVHD were fatigue (12%), diarrhea (10%), neutropenia (10%)*, pneumonia (10%), sepsis (10%), hypokalemia (7%), headache (5%), musculoskeletal pain (5%), and pyrexia (5%).
Twenty-four percent of patients receiving IMBRUVICA® in the cGVHD trial discontinued treatment due to adverse reactions. Adverse reactions leading to dose reduction occurred in 26% of patients.
*Treatment-emergent decreases (all grades) were based on laboratory measurements and adverse reactions.
CYP3A Inhibitors: Dose adjustment may be recommended.
CYP3A Inducers: Avoid coadministration with strong CYP3A inducers.
Hepatic Impairment (based on Child-Pugh criteria): Avoid use of IMBRUVICA® in patients with severe baseline hepatic impairment. In patients with mild or moderate impairment, reduce IMBRUVICA® dose.
Please see Full Prescribing Information: https://www.imbruvica.com/prescribing-information.
About VENCLEXTA® (venetoclax) in the U.S.
VENCLEXTA is an oral B-cell lymphoma-2 (BCL-2) inhibitor developed by AbbVie and Genentech, a member of the Roche Group. VENCLEXTA targets a specific protein in the body called BCL-2. When you have CLL, BCL-2 may build up and prevent cancer cells from self-destructing naturally. VENCLEXTA targets BCL-2 in order to help restore the process of apoptosis.4 Through apoptosis, your body allows cancer cells and normal cells to self-destruct.
VENCLEXTA has been granted four Breakthrough Therapy Designations from the FDA including for the combination treatment of patients with untreated AML not eligible for standard induction chemotherapy. This designation is intended to expedite the development and review of therapies for serious or life-threatening conditions.3 In January 2016, AbbVie announced that the FDA granted priority review for the single agent NDA application for VENCLEXTA.
In April 2016, U.S. FDA granted accelerated approval of VENCLEXTA for the treatment of patients with relapsed/refractory CLL with 17p deletion, as detected by an FDA-approved test.4 This indication is approved under accelerated approval based on overall response rate.4 Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.4
AbbVie and Genentech are committed to BCL-2 research with venetoclax, which is currently being evaluated in combination with other agents in Phase 3 clinical trials for the treatment of relapsed/refractory and first-line CLL,5 along with early phase studies in several cancers.4,6,7,8,9
Venetoclax is under evaluation by health authorities in multiple countries, and is currently approved in more than 49 nations, including the U.S.
What is VENCLEXTA® (venetoclax)?
VENCLEXTA® (venetoclax) is a prescription medicine used to treat people with chronic lymphocytic leukemia (CLL) with 17p deletion who have received at least one prior treatment.
VENCLEXTA was approved based on response rate. There is an ongoing study to find out how VENCLEXTA works over a longer period of time.
It is not known if VENCLEXTA is safe and effective in children.
Important Safety Information
What is the most important information I should know about VENCLEXTA?
VENCLEXTA can cause serious side effects, including:
Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. Your doctor will do tests for TLS. It is important to keep your appointments for blood tests. You will receive other medicines before starting and during treatment with VENCLEXTA to help reduce your risk of TLS. You may also need to receive intravenous (IV) fluids into your vein. Tell your doctor right away if you have any symptoms of TLS during treatment with VENCLEXTA, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain.
Drink plenty of water when taking VENCLEXTA to help reduce your risk of getting TLS. Drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before your first dose, on the day of your first dose of VENCLEXTA, and each time your dose is increased.
Who should not take VENCLEXTA?
Certain medicines must not be taken when you first start taking VENCLEXTA and while your dose is being slowly increased.
- Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. VENCLEXTA and other medicines may affect each other, causing serious side effects.
- Do not start new medicines during treatment with VENCLEXTA without first talking with your doctor.
What should I tell my doctor before taking VENCLEXTA?
Before taking VENCLEXTA, tell your doctor about all of your medical conditions, including if you:
- Have kidney or liver problems.
- Have problems with your body salts or electrolytes, such as potassium, phosphorus, or calcium
- Have a history of high uric acid levels in your blood or gout
- Are scheduled to receive a vaccine. You should not receive a "live vaccine" before, during or after treatment with VENCLEXTA until your doctor tells you it is okay. If you are not sure about the type of immunization or vaccine, ask your doctor. These vaccines may not be safe or may not work as well during treatment with VENCLEXTA.
- Are pregnant or plan to become pregnant. VENCLEXTA may harm your unborn baby. If you are able to become pregnant, your doctor should do a pregnancy test before you start treatment with VENCLEXTA, and you should use effective birth control during treatment and for 30 days after the last dose of VENCLEXTA.
- Are breastfeeding or plan to breastfeed. It is not known if VENCLEXTA passes into your breast milk. Do not breastfeed during treatment with VENCLEXTA.
What should I avoid while taking VENCLEXTA?
You should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit while you are taking VENCLEXTA. These products may increase the amount of VENCLEXTA in your blood.
What are the possible side effects of VENCLEXTA?
VENCLEXTA can cause serious side effects, including:
- Low white blood cell count (neutropenia). Low white blood cell counts are common with VENCLEXTA, but can also be severe. Your doctor will do blood tests to check your blood counts during treatment with VENCLEXTA. Tell your doctor right away if you have a fever or any signs of an infection.
The most common side effects of VENCLEXTA include low white blood cell count, diarrhea, nausea, low red blood cell count, upper respiratory tract infection, low platelet count, and feeling tired.
VENCLEXTA may cause fertility problems in males. This may affect your ability to father a child. Talk to your doctor if you have concerns about fertility.
These are not all the possible side effects of VENCLEXTA. Tell your doctor if you have any side effect that bothers you or that does not go away.
The full U.S. prescribing information for VENCLEXTA can be found here.
Patient Assistance Program
For those who qualify, AbbVie and Genentech offer patient assistance programs for people taking Venclexta in the U.S.
About EMPLICITI™ (elotuzumab) in the U.S.
EMPLICITI is an immunostimulatory antibody that specifically targets Signaling Lymphocyte Activation Molecule Family member 7 (SLAMF7), a cell-surface glycoprotein. SLAMF7 is expressed on myeloma cells independent of cytogenetic abnormalities. SLAMF7 is also expressed on Natural Killer cells, plasma cells and at lower levels on specific immune cell subsets of differentiated cells within the hematopoietic lineage.10
EMPLICITI has a dual mechanism-of-action. It directly activates the immune system through Natural Killer cells via the SLAMF7 pathway. EMPLICITI also targets SLAMF7 on myeloma cells, tagging these malignant cells for Natural Killer cell-mediated destruction via antibody-dependent cellular toxicity.
On November 30, 2015, the U.S. Food and Drug Administration (FDA) approved EMPLICITI in combination with lenalidomide and dexamethasone in patients with multiple myeloma who have received one to three prior therapies. The safety and efficacy of EMPLICITI is still being evaluated by other health authorities. Bristol-Myers Squibb and AbbVie are co-developing EMPLICITI, with Bristol-Myers Squibb solely responsible for commercial activities.
EMPLICITI™ (elotuzumab) U.S. IMPORTANT SAFETY INFORMATION
WHAT IS EMPLICITI?
EMPLICITI™ (elotuzumab) is a prescription medicine used to treat multiple myeloma in combination with the medicines REVLIMID® (lenalidomide) and dexamethasone in people who have received one to three prior treatments for their multiple myeloma.
It is not known if EMPLICITI is safe and effective in children.
IMPORTANT SAFETY INFORMATION
EMPLICITI is used in combination with REVLIMID and dexamethasone. It is important to remember that the safety information for these medications also applies to EMPLICITI combination therapy.
Before you receive EMPLICITI, tell your healthcare provider about all of your medical conditions, including if you:
- have an infection
- are pregnant or plan to become pregnant. It is not known if EMPLICITI may harm your unborn baby. However, REVLIMID may cause birth defects or death of an unborn baby.
- Before receiving EMPLICITI with REVLIMID and dexamethasone, females and males must agree to the instructions in the REVLIMID REMS® program. This program has specific requirements about birth control (contraception), pregnancy testing, blood donation, and sperm donation that you need to know. Talk to your healthcare provider to learn more about REVLIMID.
- are breastfeeding or plan to breastfeed. It is not known if EMPLICITI passes into breast milk. You should not breastfeed during treatment with EMPLICITI and REVLIMID and dexamethasone.
- Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Serious side effects that can occur with EMPLICITI treatment are:
- Infusion reactions can happen during your infusion or within 24 hours after your infusion of EMPLICITI. Your healthcare provider will give you medicines before each infusion of EMPLICITI to help reduce the risk of an infusion reaction.
- If you have an infusion reaction while receiving EMPLICITI, your healthcare provider will slow or stop your infusion and treat your reaction. If you have a severe infusion reaction your healthcare provider may stop your treatment completely.
- Tell your healthcare provider or get medical help right away if you have any of these symptoms after your infusion with EMPLICITI: fever, chills, rash, trouble breathing, dizziness, light-headedness.
- Those receiving EMPLICITI with REVLIMID and dexamethasone may develop infections; some can be serious.
- Tell your healthcare provider right away if you have any of the signs and symptoms of an infection, including: fever, flu-like symptoms, cough, shortness of breath, burning with urination, or a painful skin rash.
Risk of new cancers (malignancies)
- Those receiving EMPLICITI with REVLIMID and dexamethasone have a risk of developing new cancers.
- Talk with your healthcare provider about your risk of developing new cancers if you receive EMPLICITI.
- Your healthcare provider will check you for new cancers during your treatment with EMPLICITI.
- EMPLICITI may cause liver problems. Your healthcare provider will do blood tests to check your liver during treatment with EMPLICITI.
- Tell your healthcare provider if you have signs and symptoms of liver problems, including: tiredness, weakness, loss of appetite, yellowing of your skin or eyes, color changes in your stools, confusion, or swelling of the stomach area.
The most common side effects of EMPLICITI include:
- numbness, weakness, tingling, or burning pain in your arms or legs
- sore throat or runny nose
- upper respiratory tract infection
- decreased appetite
These are not all of the possible side effects of EMPLICITI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please read Patient Information in the full Prescribing Information.
About Depatuxizumab Mafodotin (Depatux-M; ABT-414)
Depatuxizumab mafodotin, previously known as ABT-414, is an investigational antibody-drug-conjugate (ADC) being developed by AbbVie researchers with components in-licensed from Life Science Pharmaceuticals, Inc. and Seattle Genetics.11 Depatuxizumab mafodotin is a biomarker-driven therapy that binds to an epitope that is exposed on tumor cells with epidermal growth factor receptor (EGFR) amplification and delivers a potent cytotoxin, a substance toxic to cells, that is released inside the tumor cell. It is being evaluated for EGFR-amplified newly diagnosed or recurrent glioblastoma (GBM), an aggressive malignant brain tumor.12
In 2014, the U.S. Food and Drug Administration (FDA) and the European Commission (EC) granted depatuxizumab mafodotin Orphan Drug Designation (ODD) for the treatment of GBM and glioma in adults, respectively.13,14 In 2016, the FDA granted depatuxizumab mafodotin Rare Pediatric Disease Designation for the treatment of diffuse intrinsic pontine glioma (DIPG), a type of pediatric brain tumor.15 Depatuxizumab mafodotin is an investigational compound and its efficacy and safety have not been established by the FDA or any other health authority.
About Rovalpituzumab Tesirine (Rova-T)
Rovalpituzumab tesirine (Rova-T) is an investigational antibody-drug conjugate (ADC) targeting delta-like protein 3 (DLL3), which is expressed in about 80 percent of small cell lung cancer (SCLC) patient tumors. It is prevalent on SCLC tumor cells, but not present in healthy tissue.16 Rova-T combines a targeted antibody with a cytotoxic agent to deliver a substance toxic to cells directly to the DLL3-expressing cancer cells. Rova-T is under investigation for the treatment of SCLC.17 Two randomized Phase 3 trials in the second-line and first-line maintenance setting are ongoing. Additional studies are underway in multiple neuroendocrine tumor types, metastatic melanoma, and glioblastoma (GBM).18
Rova-T is an investigational compound and its efficacy and safety have not been established by the U.S. Food and Drug Administration (FDA) or any other health authority.
Veliparib is an investigational oral poly (adenosine diphosphate [ADP]–ribose) polymerase (PARP) inhibitor being evaluated in multiple tumor types.19,20 PARP is a naturally-occurring enzyme in the body that repairs damage to DNA in cells. While this repair is a useful process to maintain the integrity of healthy cells, the same process may also help repair DNA in cancer cells, causing them to survive.21
Discovered and developed by AbbVie researchers, veliparib is being studied in combination with chemotherapy or radiation to help determine whether it can improve the survival outcome of common DNA-damaging therapies, such as chemotherapy or radiation, compared to platinum chemotherapy regimens alone.19 Veliparib is currently being studied in more than a dozen cancers, including in Phase 3 studies in advanced or metastatic non-squamous non-small cell lung cancer (NSCLC), ovarian cancer and BRCA1/2 breast cancer.22 Veliparib is an investigational medicine and its efficacy and safety have not been established by the U.S. Food and Drug Administration (FDA) or any other health authority.
About ABBV-075 (Mivebresib), ABBV-165 and PF-06647020 (PF-7020)
Mivebresib (ABBV-075) is a small molecule Bromodomain and Extra-Terminal motif (BET) inhibitor being studied in a Phase 1 clinical trial in patients with advanced hematologic malignancies and solid tumors.23 ABT-165 is Dual Variable Domain Immunoglobulin (DVD) targeting DLL4 and VEGF, being investigated to treat solid tumors.24,25 PF-06647020 (PF-7020) is an investigational antibody-drug conjugate (ADC) targeting protein kinase 7 (PTK7) in Phase 1 clinical trials for advanced solid tumors such as ovarian cancer, breast cancer and non-small cell lung cancer (NSCLC).26
About AbbVie in Oncology
At AbbVie, we strive to discover and develop medicines that deliver transformational improvements in cancer treatment by uniquely combining our deep knowledge in core areas of biology with cutting-edge technologies, and by working together with our partners – scientists, clinical experts, industry peers, advocates, and patients. We remain focused on delivering these transformative advances in treatment across some of the most debilitating and widespread cancers. We are also committed to exploring solutions to help patients obtain access to our cancer medicines. With the acquisitions of Pharmacyclics in 2015 and Stemcentrx in 2016, our research and development efforts, and through collaborations, AbbVie's oncology portfolio now consists of marketed medicines and a pipeline containing multiple new molecules being evaluated worldwide in more than 200 clinical trials and more than 20 different tumor types. For more information, please visit http://abbvieoncology.com.
AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2017 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
1 IMBRUVICA US Prescribing Information, February 2018.
2 Genetics Home Reference (2018). Isolated growth hormone deficiency. http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency. Accessed May 2018.
3 U.S. Food and Drug Administration (2018). Fact Sheet: Breakthrough Therapies. Available from: https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FDASIA/ucm329491.htm. Accessed May 2018.
4 VENCLEXTA [Package Insert]. North Chicago, Ill.: AbbVie Inc.
5 Clinicaltrials.gov (2018). NCT02005471: A Study of Venetoclax in Combination With Rituximab Compared With Bendamustine in Combination With Rituximab in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia. Accessed May 2018.
6 Clinicaltrials.gov (2018). NCT01994837: A Phase 2 Study of ABT-199 in subjects with Acute Myelogenous Leukemia (AML). Accessed May 2018.
7 Clinicaltrials.gov (2018). NCT01794520: Study evaluating ABT-199 in subjects with relapsed or refractory Multiple Myeloma. Accessed May 2018.
8 Clinicaltrials.gov (2018). NCT01328626: A Phase 1 study evaluating the safety and pharmacokinetics of ABT-199 in subjects with relapsed or refractory Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma. Accessed May 2018.
9 Clinicaltrials.gov (2018). NCT01889186: A study of the efficacy of ABT-199 in subjects with relapsed/refractory or previously untreated chronic lymphocytic leukemia with the 17p deletion. Accessed May 2018.
10 Empliciti [Package Insert]. Princeton, N.J.: Bristol-Myers Squibb Company.
11 Van den Bent M, et al. ACTR-07. Efficacy of a novel antibody-drug conjugate (ADC), ABT-414, as monotherapy in epidermal growth factor receptor (EGFR) amplified, recurrent glioblastoma (GBM). Neuro Oncol. 2016; 18.
12 Omuro A, et al. Glioblastoma and other malignant gliomas: A clinical review. JAMA. 2013;310(17):1842-1850.
13 AbbVie Inc. ABT-414 Sponsor Briefing Document. Pediatric Oncology Subcommittee. November 19, 2015.
14 U.S. Food and Drug Administration (2018). Orphan Drug Designations and Approvals. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=433214. Accessed May 2018.
15 Warren KE, et al. Diffuse intrinsic pontine glioma: poised for progress. Front Oncol. 2012;2:205.
16 Saunders LR, et al. A DLL3-targeted antibody-drug conjugate eradicates high-grade pulmonary neuroendocrine tumor-initiating cells in vivo. Sci Transl Med. 2015;7(302):1-13.
17 ClinicalTrials.gov (2018). NCT02674568: Study of Rovalpituzumab Tesirine (SC16LD6.5) for Third-line and Later Treatment of Subjects With Relapsed or Refractory Delta-Like Protein 3-Expressing Small Cell Lung Cancer (TRINITY). https://clinicaltrials.gov/ct2/show/NCT02674568?term=NCT02674568&rank=1. Accessed May 2018.
18 ClinicalTrials.gov (2018). Search Results: Rovalpituzumab Tesirine. https://clinicaltrials.gov/ct2/results?term=Rovalpituzumab+Tesirine+&Search=Search. Accessed May 2018.
19 Palma JP, et al. ABT-888 confers broad in vivo activity in combination with temozolomide in diverse tumors. Clin Cancer Res. 2009;15(23):7277-7290.
20 Anders CK, et al. Poly (ADP-Ribose) polymerase inhibition: "targeted" therapy for triple-negative breast cancer. Clin Cancer Res. 2010;16(19):4702-4710.
21 Plummer ER, et al. Targeting Poly (ADP-Ribose) Polymerase: A Two-Armed Strategy for Cancer Therapy. Clin Cancer Res. 2007;13(21): 6252-6256.
22 ClinicalTrials.gov (2018). Results: Veliparib: Open Studies. https://clinicaltrials.gov/ct2/results?term=veliparib&recr=Open. Accessed May 2018.
23 ClinicalTrials.gov (2018). NCT02391480: A Study Evaluating the Safety and Pharmacokinetics of ABBV-075 in Subjects With Cancer. https://clinicaltrials.gov/ct2/show/NCT02391480. Accessed May 2018.
24 ClinicalTrials.gov (2018). NCT01946074: Study of ABT-165 in Subjects With Advanced Solid Tumors. https://clinicaltrials.gov/ct2/show/NCT01946074. Accessed May 2018.
25 ClinicalTrials.gov (2018). NCT03368859: A Study of ABT-165 Plus FOLFIRI vs Bevacizumab Plus FOLFIRI in Subjects With Metastatic Colorectal Cancer Previously Treated With Fluoropyrimidine/ Oxaliplatin and Bevacizumab. https://clinicaltrials.gov/ct2/show/NCT03368859. Accessed May 2018.
26 ClinicalTrials.gov (2018). NCT02222922: A Study Of PF-06647020 For Adult Patients With Advanced Solid Tumors. https://clinicaltrials.gov/ct2/show/NCT02222922. Accessed May 2018.
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