ROCHE VESANOID CLEARS FDA CMTE. WITH 66% RESPONSE RATE IN 35- PATIENT ACUTE PROMYELOCYTIC LEUKEMIA STUDY; HIGH-DOSE STEROID STRATEGY BEING USED WITH ATRA
Executive Summary
Roche's Vesanoid (NDA 20-438) was recommended for second-line use against refractory acute promyelocytic leukemia in a unanimous vote by FDA's Oncologic Drugs Advisory Committee on Dec. 13. The all-trans retinoic acid product was reviewed to induce remission in APL patients who are refractory to or contraindicated for anthracycline-based chemotherapy or who have failed on anthracycline- based therapy after an initial response.
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