J&J opens expanded access to daratumumab

The Janssen Biotech Inc. unit of Johnson & Johnson (NYSE:JNJ) launched an expanded access program for daratumumab to treat multiple myeloma in heavily pre-treated U.S. patients. Janssen said the compound will be available at up to 40 U.S. sites, and that the Multiple Myeloma Research Foundation (MMRF) helped identify locations for the program.

Last month, Janssen started submitting a rolling BLA to FDA for the human mAb against CD38. The compound has breakthrough therapy and Fast Track designations from FDA. J&J has exclusive, worldwide rights to daratumumab from Genmab A/S (CSE:GEN; OTCBB:GMXAY). ...