J&J (NYSE:JNJ) announced Wednesday that an FDA advisory committee, which reviews cancer drugs, voted in favor of Darzalex Faspro, an antibody therapy the company has developed with Genmab (GMAB) for a type of blood cancer called smoldering multiple myeloma.
During an AdCom meeting on Tuesday, the FDA’s Oncologic Drugs Advisory Committee voted 6-2 in favor of the risk-benefit profile of Darzalex Faspro when used as a single agent for adults with high-risk smoldering multiple myeloma.
While the AdCom recommendations are non-binding, the FDA is expected to consider the outcome of the vote as it reviews the company’s marketing application submitted in November seeking approval of Darzalex Faspro for the above patient group.
The subcutaneously delivered treatment developed with Halozyme’s (NASDAQ:HALO) Enhanze drug delivery technology is already approved in the U.S. for nine indications in MM, including four conditions as a front-line option.
