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Presentations will cover a wide range of blood diseases including multiple myeloma, lymphoma, chronic lymphocytic leukemia, acute myeloid leukemia, myelodysplastic syndromes and beta-thalassemia
First data read-out of pivotal Phase 3 MEDALIST trial in patients with myelodysplastic syndrome (MDS) to be highlighted during the ASH Plenary Session
Celgene Corporation (NASDAQ:CELG) today announced that data from more than 100 abstracts, including a study being featured as a plenary presentation and more than 40 selected for oral presentations, evaluating Celgene investigational agents and investigational uses of marketed products will be presented at the 60th American Society of Hematology Annual Meeting between Dec. 1-4 in San Diego, CA.
“Celgene is deeply committed to furthering our understanding of blood cancers and encouraged by the promise of new innovations to improve or extend the lives of patients living with these intractable diseases,” said Dr. Alise Reicin, President, Global Clinical Development for Celgene. “Importantly, this year’s ASH data highlight the advancement of Celgene’s pipeline including first-in-class compounds with the potential to transform treatment across multiple blood cancers.”
Presentations will include data from Celgene investigational agents in company-sponsored or investigator-initiated clinical studies across the company’s approved and investigational portfolio. Abstracts highlight some of the first results of key pivotal data for the company’s pipeline assets, illustrating the breadth and potential of the hematology portfolio. Of note, a first look at the results from the MEDALIST trial in patients with myelodysplastic syndrome (MDS) will be presented during the Plenary Scientific Session, which honors the top six research papers submitted for presentation at the meeting. Experts will also share results from key approved therapies and investigational CAR T cell therapies in non-Hodgkin's lymphoma, chronic lymphocytic leukemia, beta thalassemia and multiple myeloma.
Key presentations include:
Selected abstracts include*:
Plenary Session
Abstract #1: Plenary; Sunday, Dec. 2, 2:00 p.m., Hall AB, The MEDALIST Trial: Results of a Phase 3, Randomized, Double-Blind, Placebo-Controlled, Randomized Study of Luspatercept to Treat Anemia in Patients with Very Low-, Low-, or Intermediate-Risk Myelodysplastic Syndromes (MDS) with Ring Sideroblasts (RS) Who Require Red Blood Cell (RBC) Transfusions (List)
Beta Thalassemia
Abstract #163; Oral; Saturday, Dec. 1, 2:00 p.m., Room 30D, The BELIEVE Trial: Results of a Phase 3, Randomized, Double-Blind, Placebo-Controlled, Study of Luspatercept in Adult Beta-Thalassemia Patients Who Require Regular Red Blood Cell (RBC) Transfusions (Cappellini)
Myeloid Diseases
New data findings evaluate Celgene in-line and investigational therapies in myeloid diseases.
Abstract #835; Oral; Monday, Dec. 3, 2:45 p.m., Room 25B, Real-World Treatment Patterns and Comparative Effectiveness Among a Population of Elderly Patients with Acute Myeloid Leukemia (AML) (Medeiros)
Abstract #4731; Poster; Monday, Dec. 3, 6:00 p.m., Hall GH, Factors Associated with Early Therapy Initiation in Patients (Pts) with Myelodysplastic Syndromes (MDS) in the Connect® MDS/AML Disease Registry (Cogle)
Chimeric Antigen Receptor T-cell therapy (CAR T)
New data highlight growing base of research in cellular immunotherapy across multiple blood cancers.
Abstract #319; Oral; Sunday, Dec. 2, 7:30 a.m., Room 25B, Estimation of the Resource Utilization and Costs of Cytokine Release Syndrome Observed in the TRANSCEND-NHL Clinical Trial: A Micro-Costing Study (Siddiqi)
Abstract #300; Oral; Sunday, Dec. 2, 8:45 a.m., Marriott Marquis San Diego Marina, Pacific Ballroom 20, Rapid MRD-negative Responses in Patients with Relapsed/Refractory CLL Treated with Liso-cel, a CD-19-directed CAR T-cell Product: Preliminary Results from TRANSCEND CLL 004, a Phase 1/2 Study Including Patients with High-Risk Disease Previously Treated with Ibrutinib (Siddiqi)
Abstract #488; Oral; Sunday, Dec. 2, 4:45 p.m., Room 6B, Initial results from a phase 1 clinical study of bb21217, a next-generation anti-BCMA CAR T therapy (Shah)
Abstract #957; Oral; Monday, Dec. 3, 5:00 p.m., Ballroom 20A, JCARH125, Anti-BCMA CAR T-cell Therapy for Relapsed/Refractory Multiple Myeloma: Initial Proof of Concept Results from a Phase 1/2 Multicenter Study (EVOLVE) (Mailankody)
Lymphoma/Chronic Lymphocytic Leukemia (CLL)
Multiple studies evaluate novel chemotherapy-free combinations in lymphoma and chronic lymphocytic leukemia.
Abstract #445; Oral; Sunday, Dec. 2, 4:30 p.m., Hall AB, AUGMENT: A Phase III Randomized Study of Lenalidomide Plus Rituximab (R2) vs. Rituximab/Placebo in Patients with Relapsed/Refractory Indolent Non-Hodgkin’s Lymphoma (Leonard)
Abstract #446; Oral; Sunday, Dec. 2, 4:45 p.m., Hall AB, A Phase II LYSA Study of Obinutuzumab Combined with Lenalidomide for Advanced Front-Line Follicular B-Cell Lymphoma in Need of Systemic Therapy (Morschhauser)
Abstract #999; Oral; Monday, Dec. 3, 6:45 p.m., Room 6F, Lenalidomide in Combination with CHOP in Patients with Angioimmunoblastic T Cell Lymphoma (AITL): Final Analysis of Clinical and Molecular Data of a Phase 2 LYSA Study (Lemonnier)
Multiple Myeloma
New multiple myeloma data reinforces IMiD® therapies as a foundation of myeloma research.
Abstract #112; Oral; Saturday, Dec 1, 10:15 a.m., Marriott Marquis San Diego Marina, Grand Ballroom 7, Clinical Significance and Transcriptional Profiling of Persistent Minimal Residual Disease (MRD) in Multiple Myeloma (MM) Patients With Standard-Risk (SR) and High-Risk (HR) Cytogenetics (Goicoechea)
Abstract #243; Oral; Saturday, Dec. 1, 4:30 p.m., Marriott Marquis San Diego Marina, Grand Ballroom 7, Deep immunoprofiling of the bone marrow microenvironment changes underlying the multistep progression of multiple myeloma (Young)
Abstract #121; Oral; Sunday, Dec 2, 8:30 a.m., Marriott Marquis San Diego Marina, Grand Ballroom 7, Efficacy and Feasibility of Dose/Schedule-Adjusted Rd-R vs. Continuous Rd in Elderly and Intermediate-Fit Newly Diagnosed Multiple Myeloma (NDMM) Patients: RV-MM-PI-0752 Phase III Randomized Study (Larocca)
Abstract #474; Oral; Sunday, Dec 2, 5:45 p.m., Marriott Marquis San Diego Marina, Grand Ballroom 7, Immunofixation (IF) in Urine is Really Necessary to Define Complete Remission in Multiple Myeloma (MM): A Subanalysis from the PETHEMA/GEM2012MENOS65 Phase III Clinical Trial (Ubieto)
Abstract #716; Oral; Monday, Dec. 3, 10:45 a.m., Room 25B, The Impact of Lenalidomide, Bortezomib, and Dexamethasone Treatment on Health-Related Quality of Life in Transplant-Eligible Patients with Newly-Diagnosed Multiple Myeloma: Results from the IFM/DFCI 2009 Trial (Roussel)
Abstract #1960; Poster; Saturday, Dec. 1, 6:00 p.m., Hall GH, Health-Related Quality of Life among Patients with Relapsed or Refractory Multiple Myeloma who Received Pomalidomide, Bortezomib, and Low-Dose Dexamethasone Versus Bortezomib and Low-Dose Dexamethasone – Results from the Phase 3 OPTIMISMM Study (Weisel)
Abstract #2012; Poster; Saturday, Dec. 1, 6:15 p.m., Hall GH, Immune Profiling of Relapsed or Refractory Multiple Myeloma Patients Treated With Pomalidomide and Low-Dose Dexamethasone in Combination With Daratumumab (Pierceall)
Abstract #2243; Poster; Saturday, Dec. 1, 6:15 p.m., Hall GH, Real-World Outcomes for Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma (NDMM) Treated With Lenalidomide, Bortezomib, and Dexamethasone (RVd) or Vd: An Enhanced Electronic Health Records (EHR) Database Analysis (Chari)
Abstract #3271; Poster; Sunday, Dec. 2, 6:00 p.m., Hall GH, Pomalidomide + Low-Dose Dexamethasone + Daratumumab in Relapsed and/or Refractory Multiple Myeloma after Lenalidomide-Based Treatment Failure (Siegel)
Abstract #3278; Poster; Sunday, Dec. 2, 6:00 p.m., Hall GH, Pomalidomide + Bortezomib + Low-Dose Dexamethasone vs Bortezomib + Low-Dose Dexamethasone as Second-Line Treatment in Patients with Lenalidomide-Pretreated Multiple Myeloma: A Subgroup Analysis of the Phase 3 OPTIMISMM Trial (Dimopoulos)
Abstract #3445; Poster; Sunday, Dec. 2, 6:00 p.m., Hall GH, The Impact of RVD or VCD Induction on Response 3 Months after First Line Autologous Transplant in Multiple Myeloma. A single-center Retrospective Analysis (Moksnes)
Abstract #3232; Poster; Sunday, Dec. 2, 6:00 p.m., Hall GH Treatment Choices and Outcomes for Patients with Multiple Myeloma (MM) After Relapse on Lenalidomide (LEN) Maintenance Therapy (mt): Results from the Connect® MM Registry (Jagannath)
Abstract # 3245; Poster; Sunday, Dec. 2, 6:00 p.m., Hall GH, Integrated Analysis of Randomized Controlled Trials Evaluating Bortezomib + Lenalidomide + Dexamethasone or Bortezomib + Thalidomide + Dexamethasone Induction in Transplant-Eligible Newly Diagnosed Multiple Myeloma (Rosinol)
Abstract #4744; Poster; Monday, Dec. 3, 6:00 p.m., Hall GH, Relative Efficacy of Treatment Options in Newly Diagnosed Multiple Myeloma (NDMM): Results from a Systematic Literature Review (SLR) and Network Meta-Analysis (NMA) (Ramasamy)
Abstract #4737; Poster; Monday, Dec. 3, 6:00 p.m., Hall GH, Survival Analysis from the CALGB Study of Lenalidomide Maintenance Therapy in Newly Diagnosed Multiple Myeloma Post-Autologous Stem Cell Transplantation Adjusted for Crossover (McCarthy)
The safety and efficacy of investigational agents and/or investigational uses of approved marketed products have not been established. There is no guarantee that the agents will receive health authority approval or become commercially available in any country for the uses being investigated.
A complete listing of abstracts can be found on the ASH Web site at http://www.hematology.org/Annual-Meeting/Abstracts/.
*All times Pacific Standard Time
ABOUT REVLIMID
REVLIMID® (lenalidomide) in combination with dexamethasone (dex) is indicated for the treatment of patients with multiple myeloma (MM)
REVLIMID is indicated as maintenance therapy in patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT)
REVLIMID® is indicated for the treatment of patients with transfusion-dependent anemia due to low-or intermediate-1–risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities
REVLIMID® is indicated for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib
REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials
Important Safety Information
WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM
Embryo-Fetal Toxicity
Do not use REVLIMID during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting REVLIMID treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after REVLIMID treatment. To avoid embryo-fetal exposure to lenalidomide, REVLIMID is only available through a restricted distribution program, the REVLIMID REMS® program.
Information about the REVLIMID REMS® program is available at www.celgeneriskmanagement.com or by calling the manufacturer’s toll-free number 1-888-423-5436.
Hematologic Toxicity (Neutropenia and Thrombocytopenia)
REVLIMID can cause significant neutropenia and thrombocytopenia. Eighty percent of patients with del 5q MDS had to have a dose delay/reduction during the major study. Thirty-four percent of patients had to have a second dose delay/reduction. Grade 3 or 4 hematologic toxicity was seen in 80% of patients enrolled in the study. Patients on therapy for del 5q MDS should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or reduction. Patients may require use of blood product support and/or growth factors.
Venous and Arterial Thromboembolism
REVLIMID has demonstrated a significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as risk of myocardial infarction and stroke in patients with MM who were treated with REVLIMID and dexamethasone therapy. Monitor for and advise patients about signs and symptoms of thromboembolism. Advise patients to seek immediate medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. Thromboprophylaxis is recommended and the choice of regimen should be based on an assessment of the patient’s underlying risks.
CONTRAINDICATIONS
Pregnancy: REVLIMID can cause fetal harm when administered to a pregnant female and is contraindicated in females who are pregnant. 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 risk to the fetus
Severe Hypersensitivity Reactions: REVLIMID is contraindicated in patients who have demonstrated severe hypersensitivity (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis) to lenalidomide
WARNINGS AND PRECAUTIONS
Embryo-Fetal Toxicity: See Boxed WARNINGS
REVLIMID REMS® Program: See Boxed WARNINGS: Prescribers and pharmacies must be certified with the REVLIMID REMS program by enrolling and complying with the REMS requirements; pharmacies must only dispense to patients who are authorized to receive REVLIMID. Patients must sign a Patient-Physician Agreement Form and comply with REMS requirements; female patients of reproductive potential who are not pregnant must comply with the pregnancy testing and contraception requirements and males must comply with contraception requirements
Hematologic Toxicity: REVLIMID can cause significant neutropenia and thrombocytopenia. Monitor patients with neutropenia for signs of infection. Advise patients to observe for bleeding or bruising, especially with use of concomitant medications that may increase risk of bleeding. MM: Patients taking REVLIMID/dex or REVLIMID as maintenance therapy should have their complete blood counts (CBC) assessed every 7 days for the first 2 cycles, on days 1 and 15 of cycle 3, and every 28 days thereafter. MDS: Patients on therapy for del 5q MDS should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or dose reduction. Please see the Black Box WARNINGS for further information. MCL: Patients taking REVLIMID for MCL should have their CBCs monitored weekly for the first cycle (28 days), every 2 weeks during cycles 2-4, and then monthly thereafter. Patients may require dose interruption and/or dose reduction
Venous and Arterial Thromboembolism: See Boxed WARNINGS: Venous thromboembolic events (DVT and PE) and arterial thromboses (MI and CVA) are increased in patients treated with REVLIMID. Patients with known risk factors, including prior thrombosis, may be at greater risk and actions should be taken to try to minimize all modifiable factors (e.g., hyperlipidemia, hypertension, smoking). Thromboprophylaxis is recommended and the regimen should be based on patient’s underlying risks. ESAs and estrogens may further increase the risk of thrombosis and their use should be based on a benefit-risk decision
Increased Mortality in Patients with CLL: In a clinical trial in the first-line treatment of patients with CLL, single agent REVLIMID therapy increased the risk of death as compared to single agent chlorambucil. Serious adverse cardiovascular reactions, including atrial fibrillation, myocardial infarction, and cardiac failure, occurred more frequently in the REVLIMID arm. REVLIMID is not indicated and not recommended for use in CLL outside of controlled clinical trials
Second Primary Malignancies (SPM): In clinical trials in patients with MM receiving REVLIMID, an increase of hematologic plus solid tumor SPM, notably AML and MDS, have been observed. Monitor patients for the development of SPM. Take into account both the potential benefit of REVLIMID and risk of SPM when considering treatment
Increased Mortality with Pembrolizumab: In clinical trials in patients with multiple myeloma, the addition of pembrolizumab to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials
Hepatotoxicity: Hepatic failure, including fatal cases, has occurred in patients treated with REVLIMID/dex. Pre-existing viral liver disease, elevated baseline liver enzymes, and concomitant medications may be risk factors. Monitor liver enzymes periodically. Stop REVLIMID upon elevation of liver enzymes. After return to baseline values, treatment at a lower dose may be considered
Severe Cutaneous Reactions Including Hypersensitivity Reactions: Angioedema and severe cutaneous reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported. DRESS may present with a cutaneous reaction (such as rash, or exfoliative dermatitis), eosinophilia, fever, and/or lymphadenopathy with systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and/or pericarditis. These events can be fatal. Patients with a prior history of Grade 4 rash associated with thalidomide treatment should not receive REVLIMID. REVLIMID interruption or discontinuation should be considered for Grade 2-3 skin rash. REVLIMID must be discontinued for angioedema, Grade 4 rash, exfoliative or bullous rash, or if SJS, TEN, or DRESS is suspected and should not be resumed following discontinuation for these reactions
Tumor Lysis Syndrome (TLS): Fatal instances of TLS have been reported during treatment with lenalidomide. The patients at risk of TLS are those with high tumor burden prior to treatment. These patients should be monitored closely and appropriate precautions taken
Tumor Flare Reaction (TFR): TFR has occurred during investigational use of lenalidomide for CLL and lymphoma. Monitoring and evaluation for TFR is recommended in patients with MCL. Tumor flare may mimic the progression of disease (PD). In patients with Grade 3 or 4 TFR, it is recommended to withhold treatment with REVLIMID until TFR resolves to ≤Grade 1. REVLIMID may be continued in patients with Grade 1 and 2 TFR without interruption or modification, at the physician’s discretion
Impaired Stem Cell Mobilization: A decrease in the number of CD34+ cells collected after treatment (>4 cycles) with REVLIMID has been reported. Consider early referral to transplant center to optimize timing of the stem cell collection
Thyroid Disorders: Both hypothyroidism and hyperthyroidism have been reported. Measure thyroid function before start of REVLIMID treatment and during therapy
Early Mortality in Patients with MCL: In another MCL study, there was an increase in early deaths (within 20 weeks), 12.9% in the REVLIMID arm versus 7.1% in the control arm. Risk factors for early deaths include high tumor burden, MIPI score at diagnosis, and high WBC at baseline (≥10 x 109/L)
ADVERSE REACTIONS
Multiple Myeloma
Myelodysplastic Syndromes
Mantle Cell Lymphoma
DRUG INTERACTIONS
Periodic monitoring of digoxin plasma levels is recommended due to increased Cmax and AUC with concomitant REVLIMID therapy. Patients taking concomitant therapies such as erythropoietin stimulating agents or estrogen containing therapies may have an increased risk of thrombosis. It is not known whether there is an interaction between dex and warfarin. Close monitoring of PT and INR is recommended in patients with MM taking concomitant warfarin
USE IN SPECIFIC POPULATIONS
Please see full Prescribing Information, including Boxed WARNINGS.
About POMALYST/IMNOVID
POMALYST® (pomalidomide) is a thalidomide analogue indicated, in combination with dexamethasone, for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.
Important Safety Information
WARNING: EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM
Embryo-Fetal Toxicity
POMALYST is only available through a restricted distribution program called POMALYST REMS®.
Venous and Arterial Thromboembolism
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
The most common adverse reactions for POMALYST (≥30%) included fatigue and asthenia, neutropenia, anemia, constipation, nausea, diarrhea, dyspnea, upper-respiratory tract infections, back pain, and pyrexia.
In the phase III trial, nearly all patients treated with POMALYST + low-dose dex experienced at least one adverse reaction (99%). Adverse reactions (≥15% in the POMALYST + low-dose dex arm and ≥2% higher than control) included neutropenia (51.3%), fatigue and asthenia (46.7%), upper respiratory tract infection (31%), thrombocytopenia (29.7%), pyrexia (26.7%), dyspnea (25.3%), diarrhea (22%), constipation (21.7%), back pain (19.7%), cough (20%), pneumonia (19.3%), bone pain (18%), edema peripheral (17.3%), peripheral neuropathy (17.3%), muscle spasms (15.3%), and nausea (15%). Grade 3 or 4 adverse reactions (≥15% in the POMALYST + low-dose dex arm and ≥1% higher than control) included neutropenia (48.3%), thrombocytopenia (22%), and pneumonia (15.7%).
DRUG INTERACTIONS
Avoid concomitant use of POMALYST with strong inhibitors of CYP1A2. Consider alternative treatments. If a strong CYP1A2 inhibitor must be used, reduce POMALYST dose by 50%.
USE IN SPECIFIC POPULATIONS
Please see full Prescribing Information, including Boxed WARNINGS.
About IDHIFA
IDHIFA (enasidenib) is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase-2 mutation as detected by an FDA-approved test.
Important Safety Information
WARNING: DIFFERENTIATION SYNDROME
Patients treated with IDHIFA have experienced symptoms of differentiation syndrome, which can be fatal if not treated. Symptoms may include fever, dyspnea, acute respiratory distress, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, lymphadenopathy, bone pain, and hepatic, renal, or multi-organ dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.
WARNINGS AND PRECAUTIONS
Differentiation Syndrome: See Boxed WARNING. In the clinical trial, 14% of patients treated with IDHIFA experienced differentiation syndrome, which may be life-threatening or fatal if not treated. Differentiation syndrome has been observed with and without concomitant hyperleukocytosis, as early as 10 days and at up to 5 months after IDHIFA initiation. Symptoms in patients treated with IDHIFA included acute respiratory distress represented by dyspnea and/or hypoxia and need for supplemental oxygen; pulmonary infiltrates and pleural effusion; renal impairment; fever; lymphadenopathy; bone pain; peripheral edema with rapid weight gain; and pericardial effusion. Hepatic, renal, and multi-organ dysfunction have also been observed. If differentiation syndrome is suspected, initiate systemic corticosteroids and hemodynamic monitoring until improvement. Taper corticosteroids only after resolution of symptoms. Differentiation syndrome symptoms may recur with premature discontinuation of corticosteroids. If severe pulmonary symptoms requiring intubation or ventilator support and/or renal dysfunction persist for more than 48 hours after initiation of corticosteroids, interrupt IDHIFA until signs and symptoms are no longer severe. Hospitalization for close observation and monitoring of patients with pulmonary and/or renal manifestation is recommended.
Embryo-Fetal Toxicity: Based on animal embryo-fetal toxicity studies, IDHIFA can cause embryo-fetal harm when administered to a pregnant woman. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with IDHIFA and for at least 1 month after the last dose. Pregnant women, patients becoming pregnant while receiving IDHIFA, or male patients with pregnant female partners should be apprised of the potential risk to the fetus.
ADVERSE REACTIONS
LACTATION
Many drugs are excreted in human milk and because of the potential for adverse reactions in breastfed infants, advise women not to breastfeed during treatment with IDHIFA and for at least 1 month after the last dose.
Please see full Prescribing Information, including Boxed WARNING
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. For more information, please visit www.celgene.com.
Follow Celgene on Social Media: Twitter, Pinterest, LinkedIn, Facebook and YouTube.
Forward-Looking Statements
This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," "outlook" and similar expressions. Forward-looking statements are based on management's current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the Securities and Exchange Commission.
Hyperlinks are provided as a convenience and for informational purposes only. Celgene bears no responsibility for the security or content of external websites or websites outside of its control.
View source version on businesswire.com: https://www.businesswire.com/news/home/20181101005659/en/
CelgeneInvestors:+1-908-673-9628 ir@celgene.comorMedia:+1-908-673-2275 media@celgene.com
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