FDA Accepts DACOGEN® (Decitabine) sNDA Submission in Acute Myeloid Leukemia
13 Luglio 2011 - 2:00PM
Business Wire
SuperGen, Inc. (NASDAQ:SUPG), a pharmaceutical company dedicated
to the discovery and development of novel cancer therapies,
announced that Eisai Inc. today released information that the U.S.
Food and Drug Administration (FDA) has accepted for review its
supplemental New Drug Application (sNDA) seeking approval of
DACOGEN® (decitabine) for injection in the treatment of acute
myeloid leukemia. Acute myeloid leukemia (AML) is a
life-threatening cancer of the blood for which there are few
treatment options.
Acceptance of the sNDA indicates that the FDA has found Eisai’s
submission to be sufficiently complete to review. The sNDA was
submitted to FDA on May 6, 2011.
The application is based on the Phase III randomized open-label,
multi-center trial (DACO-016) comparing DACOGEN versus patient’s
choice with physician’s advice of either supportive care or
low-dose cytarabine in patients 65 years and older with newly
diagnosed de novo or secondary AML and with poor- or
intermediate-risk cytogenetics. It is the largest randomized
controlled study in older patients with AML conducted to date.
About DACOGEN
DACOGEN is currently approved for treatment of patients with
myelodysplastic syndromes (MDS), including previously treated and
untreated, de novo and secondary MDS of all French-American-British
(FAB) subtypes (refractory anemia, refractory anemia with ringed
sideroblasts, refractory anemia with excess blasts, refractory
anemia with excess blasts in transformation, chronic myelomonocytic
leukemia), and Intermediate-1, Intermediate-2 and High-Risk
International Prognostic Scoring System (IPSS) groups.
Important Safety Information
Treatment with DACOGEN is associated with neutropenia and
thrombocytopenia. Complete blood and platelet counts should be
performed as needed to monitor response and toxicity but at a
minimum prior to each dosing cycle. After administration of the
recommended dosage for the first cycle, treatment for subsequent
cycles should be adjusted if indicated by dose adjustment
guidelines. Clinicians should consider the need for early
institution of growth factors and/or antimicrobial agents for the
prevention or treatment of infections in patients with MDS.
DACOGEN may cause fetal harm when administered to a pregnant
woman. Women of childbearing potential should be advised to avoid
becoming pregnant while receiving treatment with DACOGEN and for 1
month following completion of treatment. Women of childbearing
potential should be counseled to use effective contraception during
this time. Men should be advised not to father a child while
receiving treatment with DACOGEN and for 2 months following
completion of treatment. DACOGEN may cause fetal harm. Men with
female partners of childbearing potential should use effective
contraception during this time.
In the phase 3 clinical trial, the highest incidence of Grade 3
or Grade 4 adverse events in the DACOGEN arm was neutropenia (87%),
thrombocytopenia (85%), febrile neutropenia (23%), and leukopenia
(22%). Bone marrow suppression was the most frequent cause of dose
reduction, delay, and discontinuation. Six patients had fatal
events associated with their underlying disease and
myelosuppression (anemia, neutropenia, and thrombocytopenia) that
were considered at least possibly related to drug treatment. Of the
83 DACOGEN-treated patients, 8 permanently discontinued therapy for
adverse events compared to 1 of 81 patients in the supportive care
arm.
In the single-arm study, the highest incidence of Grade 3 or
Grade 4 adverse events was neutropenia (37%), thrombocytopenia
(24%), and anemia (22%). Seventy-eight percent of patients had dose
delays, the median duration of this delay was 7 days. Hematologic
toxicities and infections were the most frequent causes of dose
delays and discontinuation. Eight patients had fatal events due to
infection and/or bleeding that were considered at least possibly
related to drug treatment. Nineteen of 99 patients permanently
discontinued therapy for adverse events.
Other commonly occurring reactions include fatigue, pyrexia,
nausea, cough, petechiae, constipation, diarrhea, and
hyperglycemia.
If hematologic recovery from a previous DACOGEN treatment cycle
requires more than 6 weeks when administering the 3-day dosing,
then the next DACOGEN cycle should be delayed and dosing
temporarily reduced. When administering the 5-day dosing, the
DACOGEN cycle should be delayed until there is hematologic
recovery. If the following nonhematologic toxicities are present,
DACOGEN treatment should not be restarted until the toxicity is
resolved: (1) serum creatinine ≥2 mg/dL; (2) SGPt, total bilirubin
≥2 × ULN; and (3) active or uncontrolled infection.
Because there are no data on use of DACOGEN in patients with
renal or hepatic dysfunction, DACOGEN should be used with caution
in these patients.
For DACOGEN full prescribing information, please click here.
About SuperGen
SuperGen is a pharmaceutical company dedicated to the discovery
and development of novel cancer therapeutics in epigenetic and cell
signaling modulation. The Company develops products through
biochemical and clinical proof of concept to partner for further
development and commercialization. SuperGen developed DACOGEN® and
receives significant royalties on global sales.
On April 6, 2011, SuperGen entered into a definitive merger
agreement to acquire Astex Therapeutics Limited, a UK based
biotechnology company. The transaction was approved by SuperGen
stockholders on June 16, 2011 and by Astex Therapeutics
shareholders on June 13, 2011. The transaction is subject to
customary regulatory and legal approvals and is targeted to close
in July 2011.
Further information about this transaction is available at
http://www.astex-supergen.com. For more information about SuperGen,
please visit http://www.supergen.com.
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