Results from two trials (ELOQUENT-2 &
009) in which elotuzumab’s novel mechanism of action demonstrated a
significant and sustained reduction in the risk of disease
progression or death in patients with relapsed or refractory
multiple myeloma to be presented
Updated data from Opdivo (nivolumab)
early-stage research in relapsed or refractory lymphoid
malignancies to be presented
Real-world data for multiple compounds which
advance the understanding of chronic myeloid leukemia and multiple
myeloma patient care to be presented
Bristol-Myers Squibb Company (NYSE:BMY) today announced the
presentation of clinical research from its hematology portfolio at
the 20th Congress of the European Hematology Association (EHA) in
Vienna, Austria from June 11-14. Bristol-Myers Squibb will present
data for elotuzumab, an investigational immunostimulatory antibody,
in relapsed or refractory multiple myeloma; Opdivo (nivolumab), in
patients with relapsed or refractory lymphoid malignancies; and
Sprycel (dasatinib), in chronic myeloid leukemia.
Data to be presented at EHA exemplify Bristol-Myers Squibb’s
commitment to advancing the treatment of blood cancers through its
experience in hematology and its transformative science of
Immuno-Oncology.
Key oral presentations include:
- ELOQUENT-2: A Phase 3,
open-label study [Abstract #S471] comparing elotuzumab in
combination with lenalidomide and dexamethasone (ELd) versus
lenalidomide and dexamethasone alone (Ld) in patients with relapsed
or refractory multiple myeloma, will be featured in the EHA press
briefing on Friday, June 12 at 8:30 a.m. CEST and will be presented
during the Presidential Symposium, also on June 12, at 3:45 p.m.
CEST. The ELOQUENT-2 study was published in the New England Journal
of Medicine on June 2.
- Study 009: A Phase 2, open-label
study [Abstract #S103] comparing elotuzumab in combination with
bortezomib (a proteasome inhibitor) and dexamethasone versus
bortezomib and dexamethasone in patients with relapsed or
refractory multiple myeloma will be presented in an oral session on
June 12 at 12:00 p.m. CEST.
- PREAMBLE: A preliminary analysis
of an ongoing, multinational, observational study [Abstract #S148]
evaluating the real-world clinical effectiveness of standard
treatments, including immunomodulatory drugs (IMiDs) and proteasome
inhibitors (PIs), in patients with relapsed or refractory multiple
myeloma will be presented in an oral session on June 12 at 12:00
p.m. CEST.
- CheckMate -039: Updated data
from a Phase 1 study [Abstract #S808] evaluating the safety,
tolerability and potential efficacy of Opdivo in several
hematologic malignancies, including classical Hodgkin Lymphoma will
be presented in an oral session on Sunday, June 14 at 8:45 a.m.
CEST.
“Bristol-Myers Squibb is leveraging its broad experience in
oncology and leading Immuno-Oncology science to develop a portfolio
of innovative therapies, including a novel modality for multiple
myeloma, because we believe patients with blood cancers deserve
more,” said Michael Giordano, senior vice president, Head of
Development, Oncology, Bristol-Myers Squibb. “These data at EHA
illustrate our commitment to transforming survival expectations for
more patients with a variety of hematologic malignancies.”
The full set of data to be presented by Bristol-Myers Squibb
includes:
Title
Date/Time
Multiple Myeloma
An Ongoing Multinational Observational
Studyin Multiple Myeloma (PREAMBLE): A Preliminary Reportof Disease
Impact on Quality of Life
Abstract #S148
Oral Presentation
Friday, June 12
12:00-12:15 p.m. CEST
A Randomized, Open-label Phase 2 Studyof
Bortezomib/Dexamethasone with or withoutElotuzumab in Patients with
Relapsed/Refractory Multiple Myeloma Abstract #S103
Oral Presentation
Friday, June 12
12:00-12:15 p.m. CEST
ELOQUENT-2: A Phase 3, Randomized,
Open-label Studyof Lenalidomide/Dexamethasone with or without
Elotuzumabin Patients with Relapsed/Refractory Multiple Myeloma
Abstract #S471
Presidential Symposium
Friday, June 12
3:45-4:00 p.m. CEST
Lymphoma
Nivolumab in Patients with Relapsed or
RefractoryLymphoid Malignancies and Classical Hodgkin
Lymphoma:Updated Safety and Efficacy Results of a Phase 1 Study
(CA209-039)
Abstract #S80
Oral Presentation
Sunday, June 14
8:45-9:00 a.m. CEST
Chronic Myeloid Leukemia
Cardiovascular (CV) and Pulmonary Adverse
Events (AEs)
in Patients (Pts) Treated with BCR-ABL
Tyrosine KinaseInhibitors (TKIs): Updated Analysis from the FDA
AdverseEvent Reporting System (FAERS)
Abstract #P601
Poster Presentation
Saturday, June 13
5:15–6:45 p.m. CEST
Cardiovascular (CV)-Related
Hospitalization in Patientswith Chronic-Phase Chronic Myeloid
Leukemia (CP-CML)in SIMPLICITY, a Prospective Observational
Study
Abstract #E1099
Eposter Presentation
Available to view Friday, June 12, 9:30
a.m.to Saturday, June 13, 6:45 p.m. CEST
Efficacy and Safety of Dasatinib vs.
Imatinib in Latin AmericanSubpopulation from the DASISION Trial in
Patients with NewlyDiagnosed Chronic Myeloid Leukemia (CML) in
Chronic Phase (CP)
Abstract #E1119
Eposter Presentation
Available to view Friday, June 12, 9:30
a.m.to Saturday, June 13, 6:45 p.m. CEST
Estimated Glomerular Filtration Rates of
Chronic MyeloidLeukemia (CML) Patients Treated with Tyrosine Kinase
Inhibitors (TKIs)in Dasatinib Trials: DASISION (CA180-056),
CA180-034, And CA180-035
Abstract #E1100
Eposter Presentation
Available to view Friday, June 12, 9:30
a.m.to Saturday, June 13, 6:45 p.m. CEST
About Elotuzumab
Elotuzumab is an investigational immunostimulatory antibody
targeted against Signaling Lymphocyte Activation Molecule (SLAMF7),
a cell-surface glycoprotein that is highly and uniformly expressed
on myeloma cells and Natural Killer (NK) cells, but is not detected
on normal solid tissues or on hematopoietic stem
cells. Elotuzumab is being investigated to determine whether
the compound may selectively target myeloma cells. It is believed
that elotuzumab works through a dual mechanism of action: binding
to SLAMF7 on NK cells, directly activating them and binding to
SLAMF7 on myeloma cells, flagging them for NK cell recognition and
destruction.
In May 2014, the U.S. Food and Drug Administration (FDA) granted
elotuzumab Breakthrough Therapy Designation for use in combination
with one of the chemotherapy treatments for multiple myeloma
(lenalidomide, used in combination with dexamethasone) in patients
who have received one or more prior treatments. Elotuzumab is an
investigational compound, and its safety and efficacy have not been
evaluated by the FDA or any other health authority.
Bristol-Myers Squibb and AbbVie are co-developing elotuzumab,
with Bristol-Myers Squibb solely responsible for commercial
activities.
About Opdivo
Bristol-Myers Squibb has a broad, global development program to
study Opdivo in multiple tumor types consisting of more
than 50 trials – as monotherapy or in combination with other
therapies – in which more than 8,000 patients have been enrolled
worldwide.
In May 2014, the FDA granted Opdivo Breakthrough Therapy
Designation for the treatment of patients with Hodgkin Lymphoma
after failure of autologous stem cell transplant and brentuximab.
Opdivo became the first PD-1 immune checkpoint inhibitor to
receive regulatory approval anywhere in the world on July 4, 2014
when Ono Pharmaceutical Co. announced that it received
manufacturing and marketing approval in Japan for the treatment of
patients with unresectable melanoma. In the U.S., the (FDA) granted
its first approval for Opdivo for the treatment of
patients with unresectable or metastatic melanoma and disease
progression following Yervoy (ipilimumab) and, if BRAF
V600 mutation positive, a BRAF inhibitor. On March 4,
2015, Opdivo received its second FDA approval for the
treatment of patients with metastatic squamous non-small cell lung
cancer with progression on or after platinum-based
chemotherapy.
OPDIVO (nivolumab) IMPORTANT SAFETY INFORMATION
Immune-Mediated Pneumonitis
- Severe pneumonitis or interstitial lung
disease, including fatal cases, occurred with OPDIVO treatment.
Across the clinical trial experience in 691 patients with solid
tumors, fatal immune-mediated pneumonitis occurred in 0.7% (5/691)
of patients receiving OPDIVO; no cases occurred in Trial 1 or Trial
3. In Trial 1, pneumonitis, including interstitial lung disease,
occurred in 3.4% (9/268) of patients receiving OPDIVO and none of
the 102 patients receiving chemotherapy. Immune-mediated
pneumonitis occurred in 2.2% (6/268) of patients receiving OPDIVO;
one with Grade 3 and five with Grade 2. In Trial 3, immune-mediated
pneumonitis occurred in 6% (7/117) of patients receiving OPDIVO,
including, five Grade 3 and two Grade 2 cases. Monitor patients for
signs and symptoms of pneumonitis. Administer corticosteroids for
Grade 2 or greater pneumonitis. Permanently discontinue OPDIVO for
Grade 3 or 4 and withhold OPDIVO until resolution for Grade 2.
Immune-Mediated Colitis
- In Trial 1, diarrhea or colitis
occurred in 21% (57/268) of patients receiving OPDIVO and 18%
(18/102) of patients receiving chemotherapy. Immune-mediated
colitis occurred in 2.2% (6/268) of patients receiving OPDIVO; five
with Grade 3 and one with Grade 2. In Trial 3, diarrhea occurred in
21% (24/117) of patients receiving OPDIVO. Grade 3 immune-mediated
colitis occurred in 0.9% (1/117) of patients. Monitor patients for
immune-mediated colitis. Administer corticosteroids for Grade 2 (of
more than 5 days duration), 3, or 4 colitis. Withhold OPDIVO for
Grade 2 or 3. Permanently discontinue OPDIVO for Grade 4 colitis or
recurrent colitis upon restarting OPDIVO.
Immune-Mediated Hepatitis
- In Trial 1, there was an increased
incidence of liver test abnormalities in the OPDIVO-treated group
as compared to the chemotherapy-treated group, with increases in
AST (28% vs 12%), alkaline phosphatase (22% vs 13%), ALT (16% vs
5%), and total bilirubin (9% vs 0). Immune-mediated hepatitis
occurred in 1.1% (3/268) of patients receiving OPDIVO; two with
Grade 3 and one with Grade 2. In Trial 3, the incidences of
increased liver test values were AST (16%), alkaline phosphatase
(14%), ALT (12%), and total bilirubin (2.7%). Monitor patients for
abnormal liver tests prior to and periodically during treatment.
Administer corticosteroids for Grade 2 or greater transaminase
elevations. Withhold OPDIVO for Grade 2 and permanently discontinue
OPDIVO for Grade 3 or 4 immune-mediated hepatitis.
Immune-Mediated Nephritis and Renal Dysfunction
- In Trial 1, there was an increased
incidence of elevated creatinine in the OPDIVO-treated group as
compared to the chemotherapy-treated group (13% vs 9%). Grade 2 or
3 immune-mediated nephritis or renal dysfunction occurred in 0.7%
(2/268) of patients. In Trial 3, the incidence of elevated
creatinine was 22%. Immune-mediated renal dysfunction (Grade 2)
occurred in 0.9% (1/117) of patients. Monitor patients for elevated
serum creatinine prior to and periodically during treatment. For
Grade 2 or 3 serum creatinine elevation, withhold OPDIVO and
administer corticosteroids; if worsening or no improvement occurs,
permanently discontinue OPDIVO. Administer corticosteroids for
Grade 4 serum creatinine elevation and permanently discontinue
OPDIVO.
Immune-Mediated Hypothyroidism and Hyperthyroidism
- In Trial 1, Grade 1 or 2 hypothyroidism
occurred in 8% (21/268) of patients receiving OPDIVO and none of
the 102 patients receiving chemotherapy. Grade 1 or 2
hyperthyroidism occurred in 3% (8/268) of patients receiving OPDIVO
and 1% (1/102) of patients receiving chemotherapy. In Trial 3,
hypothyroidism occurred in 4.3% (5/117) of patients receiving
OPDIVO. Hyperthyroidism occurred in 1.7% (2/117) of patients,
including one Grade 2 case. Monitor thyroid function prior to and
periodically during treatment. Administer hormone replacement
therapy for hypothyroidism. Initiate medical management for control
of hyperthyroidism.
Other Immune-Mediated Adverse Reactions
- In Trial 1 and 3 (n=385), the following
clinically significant immune-mediated adverse reactions occurred
in <2% of OPDIVO-treated patients: adrenal insufficiency,
uveitis, pancreatitis, facial and abducens nerve paresis,
demyeliniation, autoimmune neuropathy, motor dysfunction, and
vasculitis. Across clinical trials of OPDIVO administered at doses
3 mg/kg and 10 mg/kg, additional clinically significant,
immune-mediated adverse reactions were identified: hypophysitis,
diabetic ketoacidosis, hypopituitarism, Guillain-Barré syndrome,
and myasthenic syndrome. Based on the severity of adverse reaction,
withhold OPDIVO, administer high-dose corticosteroids, and, if
appropriate, initiate hormone- replacement therapy.
Embryofetal Toxicity
- Based on its mechanism of action,
OPDIVO can cause fetal harm when administered to a pregnant woman.
Advise pregnant women of the potential risk to a fetus. Advise
females of reproductive potential to use effective contraception
during treatment with OPDIVO and for at least 5 months after the
last dose of OPDIVO.
Lactation
- It is not known whether OPDIVO is
present in human milk. Because many drugs, including antibodies,
are excreted in human milk and because of the potential for serious
adverse reactions in nursing infants from OPDIVO, advise women to
discontinue breastfeeding during treatment.
Serious Adverse Reactions
- In Trial 1, serious adverse reactions
occurred in 41% of patients receiving OPDIVO. Grade 3 and 4 adverse
reactions occurred in 42% of patients receiving OPDIVO. The most
frequent Grade 3 and 4 adverse drug reactions reported in 2% to
<5% of patients receiving OPDIVO were abdominal pain,
hyponatremia, increased aspartate aminotransferase, and increased
lipase.
- In Trial 3, serious adverse reactions
occurred in 59% of patients receiving OPDIVO. The most frequent
serious adverse drug reactions reported in ≥2% of patients were
dyspnea, pneumonia, chronic obstructive pulmonary disease
exacerbation, pneumonitis, hypercalcemia, pleural effusion,
hemoptysis, and pain.
Common Adverse Reactions
- The most common adverse reactions
(≥20%) reported with OPDIVO in Trial 1 were rash (21%) and in Trial
3 were fatigue (50%), dyspnea (38%), musculoskeletal pain (36%),
decreased appetite (35%), cough (32%), nausea (29%), and
constipation (24%).
Please see U.S. Full Prescribing Information for OPDIVO.
About Sprycel
Sprycel is a prescription medicine used to treat adults who have
newly diagnosed Philadelphia chromosome–positive (Ph+) chronic
myeloid leukemia (CML) in chronic phase. The effectiveness of
Sprycel in these patients is based on a study that measured two
types of response to treatment (cytogenetic and molecular) by one
year. The study is ongoing to find out how Sprycel works over a
longer period of time. Sprycel is also indicated for adults with
Ph+ CML who are no longer benefitting from, or did not tolerate,
other treatment including Gleevec® (imatinib mesylate).
SPRYCEL® (dasatinib) INDICATIONS &
IMPORTANT SAFETY INFORMATION
INDICATIONS
SPRYCEL® (dasatinib) is indicated for the treatment of adults
with:
- Newly diagnosed Philadelphia
chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic
phase. The effectiveness of SPRYCEL is based on cytogenetic and
major molecular response rates. The trial is ongoing and further
data will be required to determine long-term outcome
- Chronic, accelerated, or myeloid or
lymphoid blast phase Ph+ CML with resistance or intolerance to
prior therapy including imatinib
- Philadelphia chromosome-positive acute
lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to
prior therapy
IMPORTANT SAFETY INFORMATION
Myelosuppression:
Treatment with SPRYCEL® (dasatinib) can cause severe (NCI CTC
Grade 3/4) thrombocytopenia, neutropenia, and anemia. Their
occurrence is more frequent in patients with advanced phase CML or
Ph+ ALL than in chronic phase CML. Myelosuppression was reported in
patients with normal baseline laboratory values as well as in
patients with pre-existing laboratory abnormalities.
- Perform complete blood counts (CBCs)
weekly for the first 2 months and then monthly thereafter, or as
clinically indicated
- Myelosuppression was generally
reversible and usually managed by dose interruption, dose
reduction, or discontinuation
- Hematopoietic growth factor has been
used in patients with resistant myelosuppression
Bleeding Related Events:
SPRYCEL caused platelet dysfunction in vitro and
thrombocytopenia in humans. In all clinical trials, severe central
nervous system (CNS) hemorrhage, including fatalities, occurred in
1% of patients receiving SPRYCEL. Severe gastrointestinal
hemorrhage, including fatalities, occurred in 4% of patients and
generally required treatment interruptions and transfusions. Other
cases of severe hemorrhage occurred in 2% of patients.
- Most bleeding events were associated
with severe thrombocytopenia. Exercise caution in patients required
to take medications that inhibit platelet function or
anticoagulants
Fluid Retention:
SPRYCEL is associated with fluid retention. In clinical trials,
fluid retention was severe in up to 10% of patients. Severe
ascites, pulmonary edema, and generalized edema were each reported
in ≤1% of patients.
- Patients who develop symptoms
suggestive of pleural effusion, such as dyspnea or dry cough,
should be evaluated by chest X-ray
- Severe pleural effusion may require
thoracentesis and oxygen therapy
- Fluid retention was typically managed
by supportive care measures that included diuretics or short
courses of steroids
QT Prolongation:
In vitro data suggest that SPRYCEL has the potential to prolong
cardiac ventricular repolarization (QT interval).
- In 865 patients with leukemia treated
with SPRYCEL in five phase 2 single-arm studies, the maximum mean
changes in QTcF (90% upper bound CI) from baseline ranged from 7.0
ms to 13.4 ms
- In clinical trials of patients treated
with SPRYCEL (N=2440), 16 patients (1%) had QTc prolongation as an
adverse reaction. Twenty-two patients (1%) experienced a
QTcF>500 ms
- Administer SPRYCEL with caution to
patients who have or may develop prolongation of QTc, including
patients with hypokalemia, hypomagnesemia, or congenital long QT
syndrome and patients taking antiarrhythmic drugs, other medicinal
products that lead to QT prolongation, and cumulative high-dose
anthracycline therapy
- Correct hypokalemia or hypomagnesemia
prior to SPRYCEL administration
Congestive Heart Failure, Left Ventricular Dysfunction, and
Myocardial Infarction:
Cardiac adverse reactions were reported in 7% of 258 patients
taking SPRYCEL, including 1.6% of patients with cardiomyopathy,
heart failure congestive, diastolic dysfunction, fatal myocardial
infarction, and left ventricular dysfunction.
- Monitor patients for signs or symptoms
consistent with cardiac dysfunction and treat appropriately
Pulmonary Arterial Hypertension (PAH):
SPRYCEL may increase the risk of developing PAH, which may occur
any time after initiation, including after more than one year of
treatment. Manifestations include dyspnea, fatigue, hypoxia, and
fluid retention. PAH may be reversible on discontinuation of
SPRYCEL.
- Evaluate patients for signs and
symptoms of underlying cardiopulmonary disease prior to initiating
SPRYCEL and during treatment. If PAH is confirmed, SPRYCEL should
be permanently discontinued
Use in Pregnancy:
SPRYCEL may cause fetal harm when administered to a pregnant
woman. There are no adequate and well-controlled studies of SPRYCEL
in pregnant women.
- Women of childbearing potential should
be advised of the potential hazard to the fetus and to avoid
becoming pregnant when taking SPRYCEL
Nursing Mothers:
It is unknown whether SPRYCEL is excreted in human milk.
- Because of the potential for serious
adverse reactions in nursing infants, a decision should be made
whether to discontinue nursing or to discontinue SPRYCEL
Drug Interactions:
SPRYCEL is a CYP3A4 substrate and a weak time-dependent
inhibitor of CYP3A4.
- Drugs that may increase SPRYCEL plasma
concentrations are:
- CYP3A4 inhibitors: Concomitant
use of SPRYCEL and drugs that inhibit CYP3A4 should be avoided. If
administration of a potent CYP3A4 inhibitor cannot be avoided,
close monitoring for toxicity and a SPRYCEL dose reduction should
be considered
- Strong CYP3A4 inhibitors (eg,
ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir,
nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin,
voriconazole). If SPRYCEL must be administered with a strong CYP3A4
inhibitor, a dose decrease or temporary discontinuation should be
considered
- Grapefruit juice may also
increase plasma concentrations of SPRYCEL and should be
avoided
- Drugs that may decrease SPRYCEL plasma
concentrations are:
- CYP3A4 inducers: If SPRYCEL must
be administered with a CYP3A4 inducer, a dose increase in SPRYCEL
should be considered
- Strong CYP3A4 inducers (eg,
dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin,
phenobarbital) should be avoided. Alternative agents with less
enzyme induction potential should be considered. If the dose of
SPRYCEL is increased, the patient should be monitored carefully for
toxicity
- St John’s Wort may decrease
SPRYCEL plasma concentrations unpredictably and should be
avoided
- Antacids may decrease SPRYCEL
drug levels. Simultaneous administration of SPRYCEL and antacids
should be avoided. If antacid therapy is needed, the antacid dose
should be administered at least 2 hours prior to or 2 hours after
the dose of SPRYCEL
- H2 antagonists/proton
pump inhibitors (eg, famotidine and omeprazole): Long-term
suppression of gastric acid secretion by use of H2 antagonists or
proton pump inhibitors is likely to reduce SPRYCEL exposure.
Therefore, concomitant use of H2 antagonists or proton pump
inhibitors with SPRYCEL is not recommended
- Drugs that may have their plasma
concentration altered by SPRYCEL are:
- CYP3A4 substrates (eg,
simvastatin) with a narrow therapeutic index should be administered
with caution in patients receiving SPRYCEL
Adverse Reactions:
The safety data reflect exposure to SPRYCEL in 258 patients with
newly diagnosed chronic phase CML in a clinical trial (minimum of
36 months follow up; median duration of therapy was 37 months), and
in 2182 patients with imatinib-resistant or -intolerant CML or Ph+
ALL in clinical trials (1520 patients had a minimum of 2 years
follow up and 662 patients with chronic phase CML had a minimum of
60 months follow up).
The majority of SPRYCEL-treated patients experienced adverse
reactions at some time. Patients aged 65 years and older are more
likely to experience toxicity. In the newly diagnosed chronic phase
CML trial, the cumulative discontinuation rate was 9% with a
minimum of 36 months follow up. In patients resistant or intolerant
to prior imatinib therapy, the discontinuation rate for SPRYCEL at
2 years for adverse reactions was: 15% of patients in chronic phase
CML (all doses), 16% of patients in accelerated phase CML, 15% of
patients in myeloid blast phase CML, 8% in lymphoid blast phase
CML, and 8% in Ph+ ALL. In patients resistant or intolerant to
prior imatinib therapy with chronic phase CML (minimum 60 months
follow up), the rate of discontinuation for adverse reactions was
18% in patients treated with 100 mg once daily.
- In newly diagnosed chronic phase CML
patients:
- The most frequently reported serious
adverse reactions included pleural effusion (4%), hemorrhage (2%),
congestive heart failure (1%), pulmonary hypertension (1%), and
pyrexia (1%)
- The most frequently reported adverse
reactions (reported in ≥10% of patients) included myelosuppression,
fluid retention events (pleural effusion and superficial localized
edema), diarrhea, headache, musculoskeletal pain, rash, and
nausea
- Grade 3/4 laboratory abnormalities
included neutropenia (24%), thrombocytopenia (19%), anemia (12%),
hypophosphatemia (7%), hypocalcemia (3%), elevated bilirubin (1%),
and elevated creatinine (1%)
- In patients resistant or intolerant to
prior imatinib therapy:
- The most frequently reported serious
adverse reactions included pleural effusion (11%), gastrointestinal
bleeding (4%), febrile neutropenia (4%), dyspnea (3%), pneumonia
(3%), pyrexia (3%), diarrhea (3%), infection (2%), congestive heart
failure/cardiac dysfunction (2%), pericardial effusion (1%), and
CNS hemorrhage (1%)
- The most frequently reported adverse
reactions (reported in ≥20% of patients) included myelosuppression,
fluid retention events, diarrhea, headache, dyspnea, skin rash,
fatigue, nausea, and hemorrhage
- Grade 3/4 hematologic laboratory
abnormalities in chronic phase CML patients resistant or intolerant
to prior imatinib therapy who received SPRYCEL 100 mg once daily
with a minimum follow up of 60 months included neutropenia (36%),
thrombocytopenia (24%) and anemia (13%). Other grade 3/4 laboratory
abnormalities included: hypophosphatemia (10%) and hypokalemia (2%)
- Among chronic phase CML patients with
resistance or intolerance to prior imatinib therapy, cumulative
Grade 3 or 4 cytopenias were similar at 2 and 5 years including:
neutropenia (36% vs 36%), thrombocytopenia (23% vs 24%), and anemia
(13% vs 13%)
- Grade 3/4 elevations of transaminase or
bilirubin and Grade 3/4 hypocalcemia, hypokalemia, and
hypophosphatemia were reported in patients with all phases of CML
- Elevations in transaminase or bilirubin
were usually managed with dose reduction or interruption
- Patients developing Grade 3/4
hypocalcemia during the course of SPRYCEL therapy often had
recovery with oral calcium supplementation
Please see the full Prescribing Information
http://packageinserts.bms.com/pi/pi_sprycel.pdf.
Immuno-Oncology at Bristol-Myers
Squibb
Surgery, radiation, cytotoxic or targeted therapies have
represented the mainstay of cancer treatment over the last several
decades, but long-term survival and a positive quality of life have
remained elusive for many patients with advanced disease.
To address this unmet medical need, Bristol-Myers Squibb is
leading research in an innovative field of cancer research and
treatment known as Immuno-Oncology, which involves agents whose
primary mechanism is to work directly with the body’s immune system
to fight cancer. The company is exploring a variety of compounds
and immunotherapeutic approaches for patients with different types
of cancer, including researching the potential of combining
Immuno-Oncology agents that target different pathways in the
treatment of cancer.
Bristol-Myers Squibb is committed to advancing the science of
Immuno-Oncology, with the goal of changing survival expectations
and the way patients live with cancer.
About Bristol-Myers
Squibb
Bristol-Myers Squibb is a global pharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information about Bristol-Myers Squibb, visit www.bms.com, or
follow us on Twitter at http://twitter.com/bmsnews.
Bristol-Myers Squibb Forward-Looking
Statement
This press release contains "forward-looking statements" as that
term is defined in the Private Securities Litigation Reform Act of
1995 regarding the research, development and commercialization of
pharmaceutical products. Such forward-looking statements are based
on current expectations and involve inherent risks and
uncertainties, including factors that could delay, divert or change
any of them, and could cause actual outcomes and results to differ
materially from current expectations. No forward-looking statement
can be guaranteed. Among other risks, there can be no guarantee
that elotuzumab will receive regulatory approval or, if approved,
that it will become a commercially successful product or that
Opdivo or Sprycel will receive approval for any additional
indications described herein or, if approved, become commercially
successful in such indications. Forward-looking statements in this
press release should be evaluated together with the many
uncertainties that affect Bristol-Myers Squibb's business,
particularly those identified in the cautionary factors discussion
in Bristol-Myers Squibb's Annual Report on Form 10-K for the year
ended December 31, 2014 in our Quarterly Reports on Form 10-Q and
our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no
obligation to publicly update any forward-looking statement,
whether as a result of new information, future events or
otherwise.
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Bristol-Myers SquibbMedia:Audrey Abernathy,
609-419-5375Cell:
919-605-4521audrey.abernathy@bms.comorInvestors:Ranya
Dajani, 609-252-5330Cell: 215-666-1515ranya.dajani@bms.comorWilliam
Szablewski, 609-252-5894Cell:
215-801-0906william.szablewski@bms.com
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