Presentations will focus on a wide range of
disease areas including multiple myeloma, lymphoma, leukemia,
myelodysplastic syndromes and beta-thalassemia
Celgene Corporation (NASDAQ:CELG) today announced that data from
nearly 350 abstracts, including more than 150 oral presentations,
evaluating Celgene investigational agents and investigational uses
of marketed products will be presented at the 58th American Society
of Hematology Annual Meeting between Dec. 3-6 in San Diego,
California.
Relevant presentations will include investigational data from
Celgene agents in company-sponsored and investigator-initiated
studies.
“Once again we look forward to an impactful collection of
clinical and scientific data at ASH providing new insights into a
broad range of hematologic malignancies,” said Michael Pehl,
President, Hematology and Oncology for Celgene. “The studies being
shared this year underscore our continuing commitment to delivering
innovative therapies to patients with serious blood cancers around
the world.”
Selected abstracts include*:
Multiple Myeloma
Clinical Data on Lenalidomide in Myeloma:
Abstract #241; Oral; Saturday, Dec. 3, 4 p.m., Seaport Ballroom
ABCD (Manchester Grand Hyatt) Final Analysis of Overall Survival
from the FIRST Trial (Facon)
Abstract #537; Oral; Sunday, Dec. 4, 5 p.m., Room 29 Health
related Quality of Life in Patients with Newly Diagnosed Multiple
Myeloma Receiving Any or Lenalidomide Maintenance after Autologous
Stem Cell Transplant in the Connect MM Disease Registry
(Abonour)
Abstract #673; Oral; Monday, Dec. 5, 7 a.m., Seaport Ballroom DE
(Manchester Grand Hyatt) Intensification Therapy with
Bortezomib-Melphalan-Prednisone Versus Autologous Stem Cell
Transplantation for Newly Diagnosed Multiple Myeloma: An
Intergroup, Multicenter, Phase III Study of the European Myeloma
Network (EMN02/HO95 MM Trial) (Cavo)
Abstract #1143; Oral; Monday, Dec. 5, 5 p.m., Seaport Ballroom
ABCD (Manchester Grand Hyatt) Lenalidomide is a Highly-Effective
Maintenance Therapy in Myeloma Patients of All Ages; results of the
Phase III Myeloma XI Study (Jackson)
Abstract #4497; Poster; Monday, Dec. 5, 6 p.m., Hall GH
Pomalidomide + Low-Dose Dexamethasone Following Second-Line
Lenalidomide-Based Therapy in Relapsed or Refractory Multiple
Myeloma: A Phase 2 Study Investigating Efficacy and Safety
(Siegel)
Clinical Data on Pomalidomide in Relapsed/Refractory
Myeloma:
Abstract #2119; Poster; Saturday, Dec. 3, 5:30 p.m., Hall GH
Pembrolizumab in Combination with Pomalidomide and Dexamethasone
(PEMBRO/POM/DEX) for Pomalidomide Exposed Relapsed or Refractory
Multiple Myeloma (Wilson)
Abstract #3316; Poster; Sunday, Dec. 4, 6 p.m., Hall GH A Phase
I/II Trial of Ixazomib (Ix), Pomalidomide (POM) and Dexamethasone
(DEX), in Relapsed/Refractory (R/R) Multiple Myeloma (MM) Patients;
Responses in Double Refractory and High Risk Disease (Krishnan)
Abstract #3307; Poster; Sunday, Dec. 4, 6 p.m., Hall GH
Selective HDAC6 Inhibitor ACY-241, an Oral Tablet, Combined with
Pomalidomide and Dexamethasone: Safety and Efficacy of Escalation
and Expansion Cohorts in Patients with Relapsed or
Relapsed-and-Refractory Multiple Myeloma (ACE-MM-200 Study)
(Niesvizky)
Abstract #1145; Oral; Monday, Dec. 5, 5:30 p.m., Seaport
Ballroom BC (Manchester Grand Hyatt) A Multicenter, Open Label
Phase I/II Study of Carfilzomib, Pomalidomide and Dexamethasone in
Relapsed and/or Refractory Multiple Myeloma (MM) Patients
(Bringhen)
Abstract #1151; Oral; Monday, Dec. 5, 5:30 p.m., Hall AB
Efficacy of Daratumumab, Lenalidomide, and Dexamethasone Versus
Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple
Myeloma Patients with 1 to 3 Prior Lines of Therapy: Updated
Analysis of Pollux (Usmani)
Early Development Initiatives in Myeloma:
Abstract #1591; Poster; Saturday, Dec. 3, 5:30 p.m., Hall GH
CC-220 is a Potent Cereblon Modulating Agent that Displays
Anti-proliferative, Pro-Apoptotic and Immunomodulatory Activity on
Sensitive and Resistant Multiple Myeloma Cell Lines (Bjorklund)
Abstract #1592; Poster; Saturday, Dec. 3, 5:30 p.m., Hall GH
CC-122 is a Cereblon Modulating Agent that is Active in
Lenalidomide-Resistant and
Lenalidomide/Dexamethasone-Double-Resistant Multiple Myeloma
Pre-clinical Models (Bjorklund)
Abstract #196; Oral; Saturday, Dec. 3, 2:45 p.m., Grand Hall D
(Manchester Grand Hyatt) The Multiple Myeloma Genome Project:
Development of a Molecular Segmentation Strategy for the Clinical
Classification of Multiple Myeloma (Walker)
Lymphomas/CLL
Lenalidomide Maintenance Data:
Abstract #229; Oral; Saturday, Dec. 3, 4 p.m., Room 5AB
Lenalidomide Maintenance after Front Line Therapy Substantially
Prolongs Progression Free Survival in High Risk CLL: Interim
Results of a Phase 3 Study (CLL M1 study of the German CLL Study
Group) (Fink)
Abstract #230; Oral; Saturday, Dec. 3, 4:15 p.m., Room 5AB
Results of the Phase III Study of Lenalidomide Versus Placebo as
Maintenance Therapy Following Second-Line Treatment for Patients
with B-Cell Chronic Lymphocytic Leukemia (the CONTINUUM Trial)
(Foa)
Abstract #471; Oral; Sunday, Dec. 4, 5 p.m., Room 6B Final
Analysis of an International Double-Blind randomized Phase III
Study of Lenalidomide Maintenance in Elderly Patients with DLBCL
Treated with R-CHOP in First Line, the REMARC Study from LYSA
(Thieblemont)
Lenalidomide Combination Data:
Abstract #1798; Poster; Saturday, Dec. 3, 5:30 p.m., Hall GH
MAGNIFY: Phase IIIb Randomized Study of Lenalidomide Plus Rituximab
(R2) Followed by Lenalidomide vs. Rituximab Maintenance in Subjects
with Relapsed/Refractory Follicular, Marginal Zone, or Mantle Cell
Lymphoma (Andorsky)
Abstract #473; Oral; Sunday, Dec. 4, 5:30 p.m., Room 6B A
Multicenter Open-Label Phase 1b/2 Study of Ibrutinib in Combination
with Lenalidomide and Rituximab in Patients with Relapsed or
Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (Goy)
Abstract #1099; Oral; Monday, Dec. 5, 4:30 p.m., Ballroom 20A
Rituximab Plus Lenalidomide Versus Rituximab Monotherapy in
Untreated Follicular Lymphoma Patients in Need of Therapy. First
Analysis of Survival Endpoints of the Randomized Phase II Trial
SAKK 35/10 (Kimby)
Abstract #4199; Poster; Monday, Dec. 5, 6 p.m., Hall GH A Phase
1B Study of CC 122 in Combination with Obinutuzumab (GA101) in
Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Indolent
Non-Hodgkin Lymphoma (Michot)
Lenalidomide Data in Mantle Cell Lymphoma:
Abstract #1786; Poster; Saturday, Dec. 3, 5:30 p.m., Hall GH
Effectiveness of Lenalidomide in Mantle Cell Lymphoma Patients who
Relapsed/Progressed After or were Refractory/Intolerant to
Ibrutinib: The MCL-004 Study (Wang)
Abstract #4188; Poster; Monday, Dec. 5, 6 p.m., Hall GH CC-122
Exhibits Greater Preclinical Activity in Mantle Cell Lymphoma Than
Lenalidomide Through A Combination of Direct Cell-autonomous and
Increased Antibody Dependent Cell-mediated Cytotoxicity
(Hagner)
Surrogate Outcomes Data:
Abstract #3027; Poster; Sunday, Dec. 4, 6 p.m., Hall GH Utility
of Progression-Free Survival at 24 months (PFS24) to Predict
Subsequent Outcome for Patients with Diffuse Large B-cell Lymphoma
(DLBCL) Enrolled on Randomized Clinical Trials: Findings from a
Surrogate Endpoint in Aggressive Lymphoma (SEAL) Analysis of
Individual Patient Data (Maurer)
Abstract #1102; Oral; Monday, Dec. 5, 5:15 p.m., Ballroom 20A
Outcomes for Elderly Patients with Follicular Lymphoma (FL) Using
Individual Patient Data (IPD) from 5922 Patients in 18 Randomized
Controlled Trials (RCTs): A FL Analysis of Surrogate Hypothesis
(FLASH) Group Study (Flowers)
Abstract #4196; Poster; Monday, Dec. 5, 6 p.m., Hall GH
Evaluation of Progression-free Survival (PFS) as a Surrogate
Endpoint for Overall Survival (OS) in First-Line Therapy for
Diffuse Large B-Cell Lymphoma (DLBCL): Findings from the Surrogate
Endpoint in Aggressive Lymphoma (SEAL) Analysis of Individual
Patient Data from 7507 Patients (Shi)
MDS/AML/Beta-Thalassemia
Emerging Clinical Data from Investigational cc486, ag221
(enasidenib) and Luspatercept Studies:
Abstract #905; Oral; Monday, Dec. 5, 3:45 p.m., San Diego
Ballroom AB (Marriott Marquis San Diego Marina) CC-486 (Oral
Azacitidine) in Patients with Hematological Malignancies Who Had
Received Prior Treatment with Injectable Hypomethylating Agents
(HMAs): Results from Phase 1/2 CC-486 Studies (Garcia-Manero)
Abstract #343; Oral; Sunday, Dec. 4, 9:30 a.m., Grand Hall C
(Manchester Grand Hyatt) Enasidenib (AG-221), a Potent Oral
Inhibitor of Mutant Isocitrate Dehydrogenase 2 (IDH2) Enzyme,
Induces Hematologic Responses in Patients with Myelodysplastic
Syndromes (MDS) (Stein)
Abstract #851; Oral; Monday, Dec. 5, 3:45 p.m., Room 7 AB
Luspatercept Increases Hemoglobin, Decreases Transfusion Burden and
Improves Iron Overload in Adults with Beta-Thalassemia (Piga)
Abstract #3168; Poster; Sunday, Dec. 4, 6 p.m., Hall GH
Luspatercept Increases Hemoglobin and Reduces Transfusion Burden in
Patients with Low-Intermediate Risk Myelodysplastic Syndromes
(MDS): Long-Term results from Phase II PACE-MDS Study
(Platzbecker)
The safety and efficacy of the agents and/or uses under
investigation 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 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
(formerly known as the “RevAssist®” 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 hazard to the fetus
Allergic Reactions: REVLIMID is contraindicated in
patients who have demonstrated hypersensitivity (e.g., angioedema,
Stevens-Johnson syndrome, toxic epidermal necrolysis) to
lenalidomide
WARNINGS AND PRECAUTIONS
Embryo-Fetal Toxicity: See Boxed WARNINGS
- Females of
Reproductive Potential: See Boxed WARNINGS
- Males:
Lenalidomide is present in the semen of patients receiving the
drug. Males must always use a latex or synthetic condom during any
sexual contact with females of reproductive potential while taking
REVLIMID and for up to 28 days after discontinuing REVLIMID, even
if they have undergone a successful vasectomy. Male patients taking
REVLIMID must not donate sperm
- Blood
Donation: Patients must not donate blood during treatment
with REVLIMID and for 1 month following discontinuation of the drug
because the blood might be given to a pregnant female patient whose
fetus must not be exposed to REVLIMID
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 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 regimen is based on
patients 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 invasive SPM
notably AML and MDS have been observed. Monitor patients for the
development of SPMs. Take into account both the potential benefit
of REVLIMID and risk of SPMs when considering treatment
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
Allergic Reactions: Angioedema and serious dermatologic
reactions including Stevens-Johnson syndrome (SJS) and toxic
epidermal necrolysis (TEN) have been reported. 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 or TEN is suspected
and should not be resumed following discontinuation for these
reactions. REVLIMID capsules contain lactose; risk-benefit of
treatment should be evaluated in patients with lactose
intolerance
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 of 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
ADVERSE REACTIONS
Multiple Myeloma
- In newly diagnosed: The most
frequently reported Grade 3 or 4 reactions included neutropenia,
anemia, thrombocytopenia, pneumonia, asthenia, fatigue, back pain,
hypokalemia, rash, cataract, lymphopenia, dyspnea, DVT,
hyperglycemia, and leukopenia. The highest frequency of infections
occurred in Arm Rd Continuous (75%) compared to Arm MPT (56%).
There were more grade 3 and 4 and serious adverse reactions of
infection in Arm Rd Continuous than either Arm MPT or RD18
- The most common adverse reactions
reported in ≥20% (Arm Rd Continuous): diarrhea (46%), anemia (44%),
neutropenia (35%), fatigue (33%), back pain (32%), asthenia (28%),
insomnia (28%), rash, (26%), decreased appetite (23%), cough (23%),
dyspnea (22%), pyrexia (21%), abdominal pain (21%), muscle spasms
(20%), and thrombocytopenia (20%)
- After at least one prior therapy
the most common adverse reactions reported in ≥20% (REVLIMID/dex vs
dex/placebo): fatigue (44% vs 42%), neutropenia (42% vs 6%),
constipation (41% vs 21%), diarrhea (39% vs 27%), muscle cramp (33%
vs 21%), anemia (31% vs 24%), pyrexia (28% vs 23%), peripheral
edema (26% vs 21%), nausea (26% vs 21%), back pain (26% vs 19%),
upper respiratory tract infection (25% vs 16%), dyspnea (24% vs
17%), dizziness (23% vs 17%), thrombocytopenia (22% vs 11%), rash
(21% vs 9%), tremor (21% vs 7%), and weight decreased (20% vs
15%)
Myelodysplastic
Syndromes
- Grade 3 and 4 adverse events reported
in ≥ 5% of patients with del 5q MDS were neutropenia (53%),
thrombocytopenia (50%), pneumonia (7%), rash (7%), anemia (6%),
leukopenia (5%), fatigue (5%), dyspnea (5%), and back pain
(5%)
- Adverse events reported in ≥15% of del
5q MDS patients (REVLIMID): thrombocytopenia (61.5%), neutropenia
(58.8%), diarrhea (49%), pruritus (42%), rash (36%), fatigue (31%),
constipation (24%), nausea (24%), nasopharyngitis (23%), arthralgia
(22%), pyrexia (21%), back pain (21%), peripheral edema (20%),
cough (20%), dizziness (20%), headache (20%), muscle cramp (18%),
dyspnea (17%), pharyngitis (16%), epistaxis (15%), asthenia (15%),
upper respiratory tract infection (15%)
Mantle Cell Lymphoma
- Grade 3 and 4 adverse events reported
in ≥5% of patients treated with REVLIMID in the MCL trial (N=134)
included neutropenia (43%), thrombocytopenia (28%), anemia (11%),
pneumonia (9%), leukopenia (7%), fatigue (7%), diarrhea (6%),
dyspnea (6%), and febrile neutropenia (6%)
- Adverse events reported in ≥15% of
patients treated with REVLIMID in the MCL trial included
neutropenia (49%), thrombocytopenia (36%), fatigue (34%), anemia
(31%), diarrhea (31%), nausea (30%), cough (28%), pyrexia (23%),
rash (22%), dyspnea (18%), pruritus (17%), peripheral edema (16%),
constipation (16%), and leukopenia (15%)
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 MM patients taking concomitant warfarin
NURSING MOTHERS
Discontinue drug or nursing taking into consideration the
importance of the drug to the mother
PEDIATRIC USE
Safety and effectiveness in patients below the age of 18 have
not been established
RENAL IMPAIRMENT
REVLIMID is primarily excreted unchanged by the kidneys;
adjustments to the starting dose are recommended to provide
appropriate drug exposure in patients with moderate or severe renal
impairment and in patients on dialysis
Please see full Prescribing Information,
including Boxed WARNINGS.
About POMALYST/IMNOVID
Indication
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 contraindicated in pregnancy. POMALYST is a
thalidomide analogue. Thalidomide is a known human teratogen that
causes severe birth defects or embryo-fetal death. In females of
reproductive potential, obtain 2 negative pregnancy tests before
starting POMALYST treatment.
- Females of reproductive potential must use 2 forms of
contraception or continuously abstain from heterosexual sex during
and for 4 weeks after stopping POMALYST treatment.
POMALYST is only available through a
restricted distribution program called POMALYST
REMS®.
Venous and Arterial
Thromboembolism
- Deep venous thrombosis (DVT), pulmonary embolism (PE),
myocardial infarction, and stroke occur in patients with multiple
myeloma treated with POMALYST. Prophylactic antithrombotic measures
were employed in clinical trials. Thromboprophylaxis is
recommended, and the choice of regimen should be based on
assessment of the patient’s underlying risk factors.
CONTRAINDICATIONS
- Pregnancy: POMALYST can cause fetal
harm and is contraindicated in females who are pregnant. If
POMALYST is used during pregnancy or if the patient becomes
pregnant while taking this drug, the patient should be apprised of
the potential risk to a fetus.
WARNINGS AND PRECAUTIONS
- Embryo-Fetal
Toxicity & Females of Reproductive Potential: See Boxed
WARNINGS
- Males:
Pomalidomide is present in the semen of patients receiving the
drug. Males must always use a latex or synthetic condom during any
sexual contact with females of reproductive potential while taking
POMALYST and for up to 4 weeks after discontinuing POMALYST, even
if they have undergone a successful vasectomy. Males must not
donate sperm.
- Blood
Donation: Patients must not donate blood during treatment
with POMALYST and for 1 month following discontinuation of POMALYST
therapy because the blood might be given to a pregnant female
patient whose fetus must not be exposed to POMALYST.
- POMALYST
REMS® Program: See Boxed WARNINGS
- Prescribers and pharmacies must be
certified with the POMALYST REMS program by enrolling and
complying with the REMS requirements; pharmacies must only dispense
to patients who are authorized to receive POMALYST. 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.
- Further information about the
POMALYST REMS program is available at
www.CelgeneRiskManagement.com or by telephone at
1-888-423-5436.
- Venous and
Arterial Thromboembolism: See Boxed WARNINGS. 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 choice of regimen should
be based on assessment of the patient’s underlying risk
factors.
- Hematologic
Toxicity: Neutropenia (46%) was the most
frequently reported Grade 3/4 adverse reaction in patients taking
POMALYST in clinical trials, followed by anemia and
thrombocytopenia. Monitor complete blood counts weekly for the
first 8 weeks and monthly thereafter. Patients may require dose
interruption and/or modification.
- Hepatotoxicity: Hepatic failure,
including fatal cases, has occurred in patients treated with
POMALYST. Elevated levels of alanine aminotransferase and bilirubin
have also been observed in patients treated with POMALYST. Monitor
liver function tests monthly. Stop POMALYST upon elevation of liver
enzymes. After return to baseline values, treatment at a lower dose
may be considered.
- Hypersensitivity Reactions:
Angioedema and severe dermatologic reactions have been reported.
Discontinue POMALYST for angioedema, skin exfoliation, bullae, or
any other severe dermatologic reactions, and do not resume
therapy.
- Dizziness and
Confusional State: In patients taking POMALYST in
clinical trials, 14% experienced dizziness (1% Grade 3 or 4) and 7%
a confusional state (3% Grade 3 or 4). Instruct patients to avoid
situations where dizziness or confusional state may be a problem
and not to take other medications that may cause dizziness or
confusional state without adequate medical advice.
- Neuropathy: In patients taking
POMALYST in clinical trials, 18% experienced neuropathy (2% Grade 3
in one trial) and 12% peripheral neuropathy.
- Second Primary
Malignancies: Cases of acute myelogenous leukemia
have been reported in patients receiving POMALYST as an
investigational therapy outside of multiple myeloma.
- Tumor Lysis
Syndrome (TLS): TLS may occur in patients treated
with POMALYST. Patients at risk are those with high tumor burden
prior to treatment. These patients should be monitored closely and
appropriate precautions taken.
ADVERSE REACTIONS
Nearly all patients treated with POMALYST + low-dose dex
experienced at least one adverse reaction (99%). The most common
adverse reactions 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 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
- Pregnancy: See
Boxed WARNINGS. If pregnancy does occur during
treatment, immediately discontinue the drug and refer patient to an
obstetrician/gynecologist experienced in reproductive toxicity for
further evaluation and counseling. There is a POMALYST pregnancy
exposure registry that monitors pregnancy outcomes in females
exposed to POMALYST during pregnancy as well as female partners of
male patients who are exposed to POMALYST. This registry is also
used to understand the root cause for the pregnancy. Report any
suspected fetal exposure to POMALYST to the FDA via the MedWatch
program at 1-800-FDA-1088 and also to Celgene Corporation at
1-888-423-5436.
- Lactation: There is no information
regarding the presence of pomalidomide in human milk, the effects
of POMALYST on the breastfed infant, or the effects of POMALYST on
milk production. Pomalidomide was excreted in the milk of lactating
rats. Because many drugs are excreted in human milk and because of
the potential for adverse reactions in breastfed infants from
POMALYST, advise a nursing woman to discontinue breastfeeding
during treatment with POMALYST.
- Pediatric
Use: Safety and effectiveness have not been
established in pediatric patients.
- Geriatric
Use: No dosage adjustment is required for
POMALYST based on age. Patients >65 years of age were more
likely than patients ≤65 years of age to experience pneumonia.
- Renal
Impairment: Reduce POMALYST dose by 25% in
patients with severe renal impairment requiring dialysis. Take dose
of POMALYST following hemodialysis on hemodialysis days.
- Hepatic
Impairment: Reduce POMALYST dose by 25% in
patients with mild to moderate hepatic impairment and 50% in
patients with severe hepatic impairment.
- Smoking
Tobacco: Advise patients that smoking may reduce
the efficacy of POMALYST. Cigarette smoking reduces the AUC of
pomalidomide by 32% by CYP1A2 induction.
Please see full Prescribing Information,
including Boxed WARNINGS.
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: @Celgene, 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.
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