Genmab: FDA OKs Combo for Frontline Multiple Myeloma

• DARZALEX (daratumumab) approved by U.S. FDA in combination with lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant
• Approval based on Phase III MAIA study

Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. Food and Drug Administration (U.S. FDA) has approved the use of DARZALEX^® (daratumumab) in combination with lenalidomide and dexamethasone (Rd) for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The supplemental Biologics License Application (sBLA) for this indication was submitted by Genmab’s licensing partner, Janssen Biotech, Inc., under the Real-Time Oncology Review (RTOR) pilot program. In August 2012, Genmabgranted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

https://www.marketscreener.com/GENMAB-1412914/news/Genmab-Announces-U-S-FDA-Approval-of-DARZALEX-daratumumab-in-Combination-with-Lenalidomide-and-28825025/