New Post has been published on Green Eating And Living
Results from Phase III Study (AML-001) of VIDAZA® (Azacitidine for Injection) in Acute Myeloid Leukemia Presented at EHA | Business Wire
BOUDRY, Switzerland–(BUSINESS WIRE)–Celgene International Sàrl, a wholly-owned subsidiary of Celgene
Corporation (NASDAQ:CELG) today announced that results from AML-001, its
phase III study of VIDAZA® (azacitidine for injection) compared to
conventional care regimens (CCR) in elderly subjects with
newly-diagnosed acute myeloid leukemia (AML – >30% blasts) were
presented in a late-breaking abstract oral session at the 19th
European Hematology Association annual congress. The study was presented
by Pr. Hervé Dombret of the Hôpital Saint-Louis in Paris, France.
In the global, multi-center, randomized, open-label pivotal study,
patients at least 65 years old with newly diagnosed or secondary AML
with > 30% bone marrow blasts were pre-selected to receive one of three
regimens per investigator’s choice from intensive chemotherapy (standard
7+3 regimen), low-dose Ara-C (20 mg SC twice per day for 10 days of each
28-day cycle) or best supportive care only. Patients then randomized to
receive either azacitidine (n=241) (75 mg/m2/d SC for 7 days
of each 28-day cycle) or their predetermined CCR (n=247).
Median overall survival (OS), the primary endpoint of the study, was
10.4 months (95% CI 8.0-12.7 months) for patients receiving azacitidine
compared to 6.5 months (5.0-8.6) for patients receiving CCR, which did
not achieve statistical significance (unstratified HR=0.84 [95% CI 0.69,
Additionally, a pre-specified sensitivity analysis for OS that censored
patients at the start of subsequent AML therapy was conducted. Results
of this analysis showed a longer median overall survival for patients
receiving azacitidine (median 12.1 months 95% CI, range 9.2-14.2 months)
compared to patients receiving CCR (median 6.9 months 95% CI range
5.1-9.6 months) (stratified HR=0.76 [95% CI 0.60, 0.96], p=0.019).
One-year survival was 47% for patients receiving azacitidine compared to
34% for patients receiving CCR.
“AML in older patients is an area of significant unmet medical need, and
this study provided insight into the use of azacitidine in this
population,” said Professor Dombret.
Grade 3-4 anemia, neutropenia, febrile neutropenia, and thrombocytopenia
rates, respectively, were 16%, 26%, 28%, and 24% with azacitidine; 5%,
5%, 28%, 5% with best supportive care; 23%, 25%, 30%, 28% with low-dose
Ara-C; and 14%, 33%, 31%, 21% with intensive chemotherapy.
VIDAZA® is not indicated for patients with acute myeloid leukemia.
In the U.S., VIDAZA® (azacitidine for injection) is indicated for
treatment of patients with the following French-American-British (FAB)
myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory
anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or
thrombocytopenia or requiring transfusions), refractory anemia with
excess blasts (RAEB), refractory anemia with excess blasts in
transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).
U.S. IMPORTANT SAFETY INFORMATION
• VIDAZA is contraindicated in patients with a known hypersensitivity to
azacitidine or mannitol and in patients with advanced malignant hepatic
WARNINGS AND PRECAUTIONS:
Anemia, Neutropenia and Thrombocytopenia:
• Because treatment with VIDAZA is associated with anemia, neutropenia,
and thrombocytopenia, complete blood counts should be performed as
needed to monitor response and toxicity, but at a minimum, prior to each
Severe Pre-existing Hepatic Impairment:
• Because azacitidine is potentially hepatotoxic in patients with severe
preexisting hepatic impairment, caution is needed in patients with liver
Patients with renal impairment may be at increased risk for renal
toxicity. Also, azacitidine and its metabolites are primarily excreted
by the kidney. Therefore, these patients should be closely monitored for
• VIDAZA may cause fetal harm when administered to a pregnant woman.
Women of childbearing potential should be apprised of the potential
hazard to the fetus. Men should be advised not to father a child while
USE IN SPECIFIC POPULATIONS:
• Nursing mothers should be advised to discontinue nursing or the drug,
taking into consideration the importance of the drug to the mother
• In Studies 1 and 2, the most commonly occurring adverse reactions by
SC route were nausea (70.5%), anemia (69.5%), thrombocytopenia (65.5%),
vomiting (54.1%), pyrexia (51.8%), leukopenia (48.2%), diarrhea (36.4%),
injection site erythema (35.0%), constipation (33.6%), neutropenia
(32.3%), and ecchymosis (30.5%). Other adverse reactions included
dizziness (18.6%), chest pain (16.4%), febrile neutropenia (16.4%),
myalgia (15.9%), injection site reaction (13.6%), and malaise (10.9%).
In Study 3, the most common adverse reactions by IV route also included
petechiae (45.8%), weakness (35.4%), rigors (35.4%), and hypokalemia
• In Study 4, the most commonly occurring adverse reactions were
thrombocytopenia (69.7%), neutropenia (65.7%), anemia (51.4%),
constipation (50.3%), nausea (48.0%), injection site erythema (42.9%),
and pyrexia (30.3%). The most commonly occurring Grade 3/4 adverse
reactions were neutropenia (61.1%), thrombocytopenia (58.3%), leukopenia
(14.9%), anemia (13.7%), and febrile neutropenia (12.6%)
Please see full Prescribing Information, including CONTRAINDICATIONS,
WARNINGS AND PRECAUTIONS, and ADVERSE REACTIONS.
Celgene International Sàrl, located in Boudry, in the Canton of
Neuchâtel, Switzerland, is a wholly-owned subsidiary and international
headquarters of Celgene Corporation. Celgene Corporation, headquartered
in Summit, New Jersey, is an integrated global pharmaceutical company
engaged primarily in the discovery, development and commercialization of
innovative therapies for the treatment of cancer and inflammatory
diseases through gene and protein regulation. For more information,
please visit the Company’s website at www.celgene.com.
Follow us on Twitter @Celgene as well.
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
http://greeneatingandliving.com/homesteading/results-from-phase-iii-study-aml-001-of-vidaza-azacitidine-for-injection-in-acute-myeloid-leukemia-presented-at-eha-business-wire/
