Acting 4 months ahead of schedule, the FDA has granted an accelerated approval to the CD38-targeted monoclonal antibody daratumumab (Darzalex) as a monotherapy for patients with multiple myeloma following at least 3 prior therapies, based on data from two open-label clinical trials. In the phase II MMY2002 study, daratumumab demonstrated a 65% one-year overall survival (OS) rate and a 29.2% objective response rate (ORR).

In the phase I/II GEN501 study, the ORR was 36%, median progression-free survival (PFS) was 5.6 months (95% CI, 4.2-8.1), and the one-year OS rate was 77% (95% CI, 58-88).

"Targeting proteins that are found on the surface of cancer cells has led to the development of important oncology treatments," Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research, said in a statement. "Darzalex provides another treatment option for patients with multiple myeloma who have become resistant to other therapies." Click here to read the full article at OncLive.com