- The FDA approves Janssen's (JNJ +0.8%) Darzalex (daratumumab) for the treatment of multiple myeloma (MM) patients who have received at least three prior lines of therapy. Breakthrough Therapy-tagged daratumumab is the first monoclonal antibody approved for MM. The FDA's approval comes early. The PDUFA date was March 9.
- Janssen licensed the product from Genmab in August 2012.
-
Daratumumab is an investigational human IgG1k monoclonal antibody that binds to the transmembrane ectoenzyme CD38, found on the surface of multiple myeloma cells. Once bound, it induces rapid tumor cell death.
- Previously: FDA grants Priority Review for Janssen's daratumumab BLA (Sept. 4)
- Previously: J&J (NYSE:JNJ) unit Janssen Biotech buys the global licensing rights to cancer agent daratumumab... (Aug. 30, 2012)