The ODAC meeting will be held on
The General Function of the Committee is to provide advice and
recommendations to the
Acute myeloid leukemia is an aggressive, fast-growing cancer that starts
inside the bone marrow with production of abnormal blood cells. It is
generally a disease of older adults, with an average patient age of 67,
and is slightly more common among men than women. The most common
symptoms of AML include weight loss, tiredness, fever, night sweats, and
loss of appetite. AML can sometimes spread to other parts of the body
including the lymph nodes, liver and spleen. In 2008, there were
slightly more than 13,000 new cases of AML reported and nearly 9,000
Dacogen (decitabine) for Injection is indicated 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.
A five-day dosing regimen for Dacogen was approved by the
Dacogen is currently approved for the treatment of MDS in about
30 countries outside of
Important Safety Information for MDS Patients
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. 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. Men should be advised not to father a child while receiving treatment with Dacogen, and for 2 months following completion of treatment.
In the MDS Phase 3 controlled clinical trial, the highest incidence of Grade 3 or Grade 4 adverse events in the Dacogen arm were 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 MDS single-arm study, the highest incidence of Grade 3 or Grade 4 adverse events were neutropenia (37%), thrombocytopenia (24%), and anemia (22%). Seventy-eight percent of patients had dose delays. 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 hematological recovery from a previous Dacogen treatment cycle requires more than 6 weeks, then the next Dacogen cycle should be delayed and dosing temporarily reduced. If the following non-hematologic toxicities are present, Dacogen treatment should not be restarted until the toxicity is resolved 1) serum creatinine greater than or equal to 2 mg/dL; 2) SGPT, total bilirubin greater than or equal to 2 X ULN; and 3) active or uncontrolled infection.
There are no data on the use of Dacogen in patients with renal or hepatic dysfunction; therefore, Dacogen should be used with caution in these patients.
The full prescribing information for Dacogen is available on the Eisai website at www.eisai.com.
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