Presentations highlight innovative research in
multiple disease areas including multiple myeloma, lymphoma,
leukemia, myelodysplastic syndromes and beta-thalassemia
Celgene Corporation (NASDAQ:CELG) today announced that data from
a broad range of company-sponsored and investigator-initiated
studies evaluating Celgene investigational agents and
investigational uses of marketed products will be presented at the
22nd European Hematology Association annual meeting in Madrid,
Spain, from June 22-25, 2017.
“Research into blood cancers is at a pivotal point, where we’re
able to apply insights into the biology of disease to help evolve
the treatment pathways, as well as continue to deepen our
understanding of the disease in ways that have the potential to
positively impact patients’ lives,” said Michael Pehl, President,
Hematology and Oncology for Celgene. “The studies being shared this
year illustrate our ongoing commitment to delivering innovative
therapies to patients with serious and sometimes underserved blood
cancers.”
This year’s data presented at EHA will support the role of
Celgene therapies as the foundation of myeloma research, including
data evaluating REVLIMID® (lenalidomide) across a variety of
patient settings ranging from newly diagnosed to those receiving
maintenance treatment following autologous hematopoietic stem cell
transplant. The data also highlight the potential of Celgene
treatments across a range of blood cancers such as lymphoma, MDS
and beta-thalassemia. Findings from key Celgene research
collaborations will also be presented, including updated data from
the Phase I dose escalation and expansion study of IDHIFA®
(enasidenib) in patients with relapsed/refractory acute myeloid
leukemia and an isocitrate dehydrogenase-2 mutation.
Selected abstracts include:
Newly-Diagnosed Multiple
Myeloma
Abstract #S102; Oral; Friday, June 23, 12:00 p.m., Hall A.
Minimal Residual Disease (MRD) by Multiparameter Flow Cytometry
(MFC) in Transplant Eligible Patients with Newly Diagnosed Multiple
Myeloma (MM): Results from the EMN02/HO95 Phase 3 Trial (Oliva)
Abstract #S407; Oral; Saturday, June 24, 11:30 a.m., Hall A.
Quadruplet vs. Sequential Triplet Induction Therapy for Multiple
Myeloma Patients: Results of the MYELOMA XI Study (Pawlyn)
Abstract #S410; Oral; Saturday, June 24, 12:15 p.m., Hall A.
Carfilzomib-Lenalidomide-Dexamethasone vs.
Carfilzomib-Cyclophosphamide-Dexamethasone Induction: Planned
Interim Analysis of the Randomized Forte Trial in Newly Diagnosed
Multiple Myeloma (Gay)
Abstract #P349; Poster Discussion; Friday, June 23, 5:15 p.m.,
Hall 7. The Connect MM Registry: Impact of the Cytogenic
Abnormality (11;14) on Survival Outcomes in African American and
non-African American Patients with Newly Diagnosed Multiple Myeloma
(Gasparetto)
Relapsed/Refractory Multiple
Myeloma
Abstract #S142; Oral; Friday, June 23, 11:45 a.m., Room N109.
First-in-Human Multicenter Study of BB2121 Anti-BCMA CAR T Cell
Therapy for Relapsed/Refractory Multiple Myeloma: Updated Results
(Lin)
Abstract #S456; Oral; Saturday, June 24, 4:00 p.m., Hall A.
Phase 3 ELOQUENT-2 Study: Extended 4-Year Follow-up of Elotuzumab
plus Lenalidomide/Dexamethasone vs. Lenalidomide/Dexamethasone in
Relapsed/Refractory Multiple Myeloma (Dimopoulos)
Abstract #P343; Poster Presentation; Friday, June 23, 5:15 p.m.,
Hall 7. MM-013 Phase 2 Multicenter Study of Pomalidomide (POM) plus
Low-dose Dexamethasone (LODEX) in Patients (PTS) with
Relapsed/Refractory Multiple Myeloma (RRMM) and Renal Impairment
(RI) (Sonneveld)
Abstract #P680; Poster Presentation; Saturday, June 24, 5:30
p.m., Hall 7. Final Results of Phase (PH) 1/2 Study of Carfilzomib,
Pomalidomide, and Dexamethasone (KPD) in Patients (PTS) with
Relapsed/Refractory Multiple Myeloma (RRMM): A Multi-Center MMRC
Study (Jakubowiak)
Maintenance in Multiple Myeloma
Abstract #S781; Oral; Sunday, June 25, 8:30 a.m., Hall D.
Lenalidomide Induction and Maintenance Therapy for Transplant
Eligible Myeloma Patients: Results of the MYELOMA XI Study
(Pawlyn)
Abstract #P332; Poster Discussion; Friday, June 23, 5:15 p.m.,
Hall 7. Lenalidomide Maintenance vs. Placebo After Stem Cell
Transplant for Patients with Multiple Myeloma: Overall Survival and
Progression-free Survival After Adjusting for Treatment Crossover
in CALGB (McCarthy)
Acute Myeloid Leukemia
Abstract #S471; Oral; Saturday, June 24, 4:00 p.m., Hall D.
Enasidenib (AG-221) in Mutant-IDH2 Relapsed or Refractory Acute
Myeloid Leukemia (R/R AML): Results of a Phase 1 Dose-escalation
and Expansion Study (Stein)
Abstract #S791; Oral; Sunday, June 25, 8:30 a.m., Room N101.
Molecular Predictors of Response to Azacitidine Therapy: The
Results of the UK Trials Acceleration Programme RAVVA Study
(Craddock)
Abstract #P208; Poster Discussion; Friday, June 23, 5:15 p.m.,
Hall 7. Stable Disease with Hematologic Improvement is Clinically
Meaningful for Older Patients with Acute Myeloid Leukemia (AML)
Treated with Azacitidine (Schuh)
Abstract #P215; Poster Discussion; Friday, June 23, 5:15 p.m.,
Hall 7. Differentiation Syndrome Associated with Enasidenib
(AG-221), a Selective Inhibitor of Mutant Isocitrate Dehydrogenase
2 (MIDH2) (Fathi)
Abstract #P555; Poster Discussion; Saturday, June 24, 5:30 p.m.,
Hall 7. Response-adapted Azacitidine and Induction Chemotherapy in
Patients >60 Years Old with Newly Diagnosed AML Eligible for
Chemotherapy: Results of the DRKS00004519 Study of the East German
Study Group (Jaekel)
Lymphoma
Abstract #S467; Oral; Saturday, June 24, 4:15 p.m., Hall C.
CC-122 in Combination with Obinutuzumab (GA101): Phase IB study in
Relapsed or Refractory Patients with Diffuse Large B-cell Lymphoma,
Follicular Lymphoma or Marginal Zone Lymphoma (Michot)
Abstract #P634; Poster Discussion; Saturday, June 24, 5:30 p.m.,
Hall 7. Phase IIIB Randomized Study of Lenalidomide plus Rituximab
(R2) followed by Lenalidomide vs. Rituximab Maintenance in Patients
with Relapsed/Refractory NHL: Analysis of Follicular Lymphoma
Patients (Burke)
Myelodysplastic Syndromes
Abstract #P666; Poster Discussion; Saturday, June 24, 5:30 p.m.,
Hall 7. Luspatercept Increases Hemoglobin and Reduces Transfusion
Burden in Patients with Lower-risk Myelodysplastic Syndromes (MDS):
Long-term Results from Phase 2 PACE-MDS Study (Giagounidis)
Beta-Thalassemia
Abstract #S129; Oral; Friday, June 23, 11:45 a.m., Room N105.
Luspatercept Increases Hemoglobin and Decreases Transfusion Burden
in Adults with B-Thalassemia. (Piga)
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 EHA Learning
Center Web site at https://learningcenter.ehaweb.org/eha/.
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
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 4 weeks 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 4 weeks 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 or
REVLIMID 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 Boxed 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
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 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
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%)
- Maintenance Therapy Post
Auto-HSCT: The most frequently reported Grade 3 or 4 reactions
in ≥20% (REVLIMID arm) included neutropenia, thrombocytopenia, and
leukopenia. The serious adverse reactions of lung infection and
neutropenia (more than 4.5%) occurred in the REVLIMID arm
- The most frequently reported adverse
reactions in ≥20% (REVLIMID arm) across both maintenance studies
(Study 1, Study 2) were neutropenia (79%, 61%), thrombocytopenia
(72%, 24%), leukopenia (23%, 32%), anemia (21%, 9%), upper
respiratory tract infection (27%, 11%), bronchitis (5%, 47%),
nasopharyngitis (2%, 35%), cough (10%, 27%), gastroenteritis (0%,
23%), diarrhea (55%, 39%), rash (32%, 8%), fatigue (23%, 11%),
asthenia (0%, 30%), muscle spasm (0%, 33%), and pyrexia (8%,
21%)
- 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 patients with MM taking concomitant
warfarin
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 REVLIMID pregnancy exposure registry that
monitors pregnancy outcomes in females exposed to REVLIMID during
pregnancy as well as female partners of male patients who are
exposed to REVLIMID. This registry is also used to understand the
root cause for the pregnancy. Report any suspected fetal exposure
to REVLIMID 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 lenalidomide in human milk,
the effects of REVLIMID on the breastfed infant, or the effects of
REVLIMID on milk production. Because many drugs are excreted in
human milk and because of the potential for adverse reactions in
breastfed infants from REVLIMID, advise female patients not to
breastfeed during treatment with REVLIMID
- PEDIATRIC USE: Safety and
effectiveness have not been established in pediatric patients
- RENAL IMPAIRMENT: Adjust the
starting dose of REVLIMID based on the creatinine clearance value
and for patients on dialysis
Please see full Prescribing Information, including
Boxed WARNINGS.
About POMALYST®
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 hazard
to a fetus
WARNINGS AND PRECAUTIONS
Embryo-Fetal Toxicity
- Females of
Reproductive Potential: Must avoid pregnancy while taking
POMALYST and for at least 4 weeks after completing therapy. Must
commit either to abstain continuously from heterosexual sexual
intercourse or to use 2 methods of reliable birth control,
beginning 4 weeks prior to initiating treatment with POMALYST,
during therapy, during dose interruptions, and continuing for 4
weeks following discontinuation of POMALYST therapy. Must obtain 2
negative pregnancy tests prior to initiating therapy
- 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 28 days 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
Because of the embryo-fetal risk, POMALYST is available only
through a restricted program under a Risk Evaluation and Mitigation
Strategy (REMS) called “POMALYST REMS®.” Prescribers
and pharmacies must be certified with the program; patients must
sign an agreement form and comply with the 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: Venous
thromboembolic events (DVT and PE) and arterial thromboembolic
events (ATE) (myocardial infarction and stroke) have been observed
in patients treated with POMALYST. In Trial 2, where anticoagulant
therapies were mandated, thromboembolic events occurred in 8.0% of
patients treated with POMALYST and low dose-dexamethasone (Low-dose
Dex) vs 3.3% treated with high-dose dexamethasone. Venous
thromboembolic events (VTE) occurred in 4.7% of patients treated
with POMALYST and Low-dose Dex vs 1.3% treated with high-dose
dexamethasone. Arterial thromboembolic events include terms for
arterial thromboembolic events, ischemic cerebrovascular
conditions, and ischemic heart disease. Arterial thromboembolic
events occurred in 3.0% of patients treated with POMALYST and
Low-dose Dex vs 1.3% treated with high-dose dexamethasone. 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).
Hematologic Toxicity: In trials 1 and 2 in patients who
received POMALYST + Low-dose Dex, neutropenia (46%) was the most
frequently reported Grade 3/4 adverse reaction, followed by anemia
and thrombocytopenia. Monitor patients for hematologic toxicities,
especially neutropenia. 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 trials 1 and 2 in
patients who received POMALYST + Low-dose Dex, 14% experienced
dizziness and 7% a confusional state; 1% of patients experienced
Grade 3 or 4 dizziness and 3% experienced a Grade 3 or 4
confusional state. 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 trials 1 and 2, patients who received
POMALYST + Low-dose Dex experienced neuropathy (18%) and peripheral
neuropathy (~12%). In trial 2, 2% of patients experienced Grade 3
neuropathy.
Risk of 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: Tumor lysis syndrome (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%). In trial 2, 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%), edema peripheral (17.3%), peripheral
neuropathy (17.3%), bone pain (18%), nausea (15%), and muscle
spasms (15.3%). Grade 3 or 4 adverse reactions included neutropenia
(48.3%), thrombocytopenia (22%), and pneumonia (15.7%).
DRUG INTERACTIONS
Pomalidomide is primarily metabolized by CYP1A2 and CYP3A.
Pomalidomide is also a substrate for P-glycoprotein (P-gp). Avoid
the use of strong CYP1A2 inhibitors. If medically necessary to
co-administer strong inhibitors of CYP1A2 in the presence of strong
inhibitors of CYP3A4 and P-gp, reduce POMALYST dose by 50%.
Cigarette smoking may reduce pomalidomide exposure due to CYP1A2
induction. Patients should be advised that smoking may reduce the
efficacy of pomalidomide.
USE IN SPECIFIC POPULATIONS
Pregnancy: 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. Report any suspected fetal
exposure to POMALYST to the FDA via the MedWatch program at
1-800-332-1088 and also to Celgene Corporation at
1-888-423-5436.
Nursing Mothers: It is not known if pomalidomide is
excreted in human milk. 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 nursing infants
from POMALYST, a decision should be made whether to discontinue
nursing or to discontinue the drug, taking into account the
importance of the drug to the mother.
Pediatric Use: Safety and effectiveness of POMALYST in
patients under the age of 18 have not been established.
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 and Hepatic Impairment: Pomalidomide is metabolized
in the liver. Pomalidomide and its metabolites are primarily
excreted by the kidneys. The influence of renal and hepatic
impairment on the safety, efficacy, and pharmacokinetics of
pomalidomide has not been evaluated. Avoid POMALYST in patients
with a serum creatinine >3.0 mg/dL. Avoid POMALYST in patients
with serum bilirubin >2.0 mg/dL and AST/ALT >3.0 x ULN.
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. Celgene undertakes 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
Celgene’s Annual Report on Form 10-K and other reports filed with
the Securities and Exchange Commission.
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