Priority Rev. Schedule for BMS and Otsuka’s sNDA for Sprycel as 1st-Line CML Therapy

Jul 12 2010

FDA Sets Priority Review Schedule for BMS and Otsuka’s sNDA for Sprycel as First-Line CML Therapy

FDA accepted an sNDA for Bristol-Myers Squibb (BMS) and Otsuka Pharmaceutical’s chronic myeloid leukemia (CML) drug, Sprycel®, and has granted the application priority review status. The sNDA specifically relates to use of the BCR-ABL inhibitor for the treatment of adult patients with newly diagnosed CML in chronic phase. The projected FDA action data is October 28.

Sprycel was originally developed by BMS. The drug has been commercialized in the U.S., Japan, and major European countries in collaboration with Otsuka. Sprycel is already approved in the U.S. for the treatment of all stages of CML in adult patients who are resistant or intolerant to prior therapy including Novartis’ Gleevec/Glivec. Sprycel is separately approved for treating adults with Philadelphia chromosome (Ph+) acute lymphoblastic leukemia (ALL) who are resistant to or intolerant to prior therapy.


Read the rest of the article here.

© 2010 Genetic Engineering & Biotechnology News, All Rights Reserved.