www.fdanews.com/articles/196923-bms-gets-priority-review-for-investigational-leukemia-treatment
BMS Gets Priority Review for Investigational Leukemia Treatment
May 4, 2020
The FDA granted a priority review to Bristol-Myers Squibb’s CC-486 as a maintenance treatment for adults in remission with acute myeloid leukemia.
BMS based its new drug application on the results of a phase 3 trial that showed an improvement in overall survival for patients receiving maintenance treatment with CC-486 vs. a placebo.
CC-486 is not currently approved for use in any country. The& FDA& is expected to make a decision on approval by Sept. 3.