FDA Panel Backs Drug for Rare Type of Leukemia

MedPage Today (03/21/12) Walker, Emily P.
The FDA’s Oncologic Drugs Advisory Committee has voted 7-4 to approve Talon Therapeutics’ Marqibo, or vincristine sulfate liposomal injection, for use in adults with Philadelphia chromosome negative acute lymphoblastic leukemia who have failed at least two prior treatments or who are on at least their second relapse. Adult ALL is extremely rare--just 2,000 cases per year in the United States, and the five-year survival rate for those who have relapsed is just 7 percent. There is no other drug on the market for this subset of patients. The panelists did not wholeheartedly approve the drug as it has not been proven to be extremely effective, but they said patients should have the option. In Talon’s phase II single-arm, open-label, dose-escalation trial of the drug, ten of 65 patients reached complete remission that lasted a median of 28 days, and median overall survival for participants who received the drug was 7.7 months compared to 4.6 for the overall population.

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