ATLANTA ? The FDA's Oncologic Drugs Advisory Committee (ODAC) unanimously recommended approval of Sprycel (dasatinib) for chronic myelogenous leukemia (CML) patients who are refractory or intolerant to Gleevec (imatinib mesylate).
ATLANTA, June 3 ? The FDA's Oncologic Drugs Advisory Committee (ODAC) unanimously recommended approval of Sprycel (dasatinib) for chronic myelogenous leukemia (CML) patients who are refractory or intolerant to Gleevec (imatinib mesylate).
Meeting during the opening day of the American Society of Clinical Oncology (ASCO) meeting, the ODAC session was believed to be the first time an agency advisory committee convened outside the Washington area.
The session was marked by a lack of controversy or dispute. In short, the FDA advisers felt that Bristol-Myers Squibb, the maker of Sprycel, answered most of their questions and the advisers seemed to like what they heard.
The company submitted one phase I trial and five phase II trials for review that enrolled a total of 94 Gleevec-intolerant patients and 457 Gleevec-resistant patients. In the data reported Sprycel demonstrated hematologic and cytogenic response in 31% to 59% of patients who were resistant or intolerant to Gleevec.
Moreover, and most responses occurred within the first three months.
Responses were observed in all CML phases. The duration of response was four to five months for lymphoid blast CML, with longer duration of response observed in chronic phase, accelerated phase, and myeloid blast CML.
The effective dose was 70 mg bid, but there were some indications that a lower dose might also have efficacy. In chronic phase CML patients, the Gleevec-intolerant patients had a higher response rate than Gleevec-resistant patients.
Although the company is seeking FDA approval for the Sprycel for treatment of Gleevec-resistant patients, Bristol-Myers Squibb is also conducting trials of the drug as a first-line agent. Gleevec is indicated as first-line therapy for all phases of CML.