Bristol Sprycel For Gleevec-Resistant Leukemia To Get Committee Review At June ASCO Meeting
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA’s Oncologic Drugs Advisory Committee will meet in Atlanta to review Bristol’s multi-targeted kinase inhibitor dasatinib for two leukemia indications.
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FDA will take its Oncologic Drugs Advisory Committee on the road to review Bristol-Myers Squibb's Sprycel (dasatinib) for the treatment of resistant leukemias. The meeting will take place on June 2 in Atlanta, Ga. on the first day of the American Society for Clinical Oncology annual meeting. The ASCO meeting runs June 2-6. Many of the committee members and FDA oncology reviewers regularly attend the meeting, as do Bristol representatives. FDA will give the committee members a break, as they are likely to have time constraints during the ASCO meeting; the agency is only dedicating a half-day to the review, from 10 a.m. to 2 p.m. Bristol is seeking accelerated approval for dasatinib for the "treatment of adults with chronic, accelerated, or blast phase chronic myeloid leukemia with resistance or intolerance to prior therapy, including imatinib" (Novartis' Gleevec ). The company is also seeking an indication for "treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia, and lymphoid blast chronic myeloid leukemia with resistance or intolerance to prior therapy." [Editor's note: To 1 watch a webcast or order a video/DVD of this meeting, visit FDAAdvisoryCommittee.com.] Bristol submitted the NDA for Sprycel on Dec. 28. FDA is giving the application a priority review, which would give the product a June 28. user fee date. The submission is primarily based on Phase II data from 1,000 Gleevec-resistant or intolerant patients with CML in various phases of disease. According to data presented at the American Society for Hematology in December, 32% of the 74 patients with myeloid blast phase had a major hematologic response with dasatinib and 24% of patients experienced a complete hematologic response. In 107 accelerated phase patients, dasatinib showed a 59% major hematologic response rate with 33% of patients experiencing a complete hematologic response. The response was even higher in chronic phase patients who were intolerant or resistant to Gleevec. Among 59 intolerant patients, 97% had a complete hematologic response. The response rate for 127 resistant chronic phase patients was 87%. Complete cytogenetic response rates for the myeloid blast and accelerated phase patients were in the 30% range, while 22% of chronic phase patients resistant to imatinib had a complete cytogenetic response; 56% of intolerant chronic phase patients had a complete cytogenetic response. The advisory committee will have to determine if the Phase II data on hematologic and cytogenetic responses are enough to predict a clinical benefit for dasatinib, such as prolonged survival in CML patients. Bristol estimates that 15%-20% of patients treated for CML do not achieve major cytogenetic responses to Gleevec within the first 12 months and 5%-10% develop resistance. Dasatinib is an oral multi-target kinase inhibitor, which, Bristol reports, has a pre-clinical potency greater than imatinib. -Danielle Foullon |