FDA OKs expanded use of J&J’s Darzalex

Genmab A/S (GMAB -0.5%) announces that the FDA has approved the use of licensee Janssen Biotech’s (JNJ -1.9%) Darzalex (daratumumab), combined with Takeda’s Velcade (bortezomib), thalidomide and dexamethasone, to treat newly diagnosed multiple myeloma (MM) patients who are eligible for autologous stem cell transplant (ASCT).

The agency first approved the CD38-directed cytolytic antibody in November 2015 for previously treated MM. In June, it approved the above combination for newly diagnosed MM patients who are ineligible for ASCT.

https://seekingalpha.com/news/3502120-fda-oks-expanded-use-j-and-js-darzalex