Tretinoin for acute promyelocytic leukemia
Executive Summary
Multicenter trial comparing all trans-retinoic acid (Roche's tretinoin) plus chemotherapy to chemotherapy alone in newly diagnosed acute promyelocytic leukemia finds significantly higher event-free survival at six months and one year in patients receiving ATRA and chemo (91% and 75% versus 73% and 47%), according to data presented at ASCO. Forty of 44 patients in the ATRA plus chemo group achieved complete response, compared to 32 out of 40 patients in the chemo only group. All 10 patients in the chemo group who relapsed were salvaged by ATRA. Roche expects to file an NDA this year for tretinoin as an orphan drug for APL.
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