- FDA Announcements
FDA Approved for RRMM: Daratumumab + Pomalidomide & Dexamethasone
HORSHAM, PA, June 16, 2017 – Janssen Biotech, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved the immunotherapy DARZALEX® (daratumumab) in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide (an immunomodulatory agent) and a proteasome inhibitor (PI).1 Clinical trial results showed an overall response rate (ORR) of 59.2 percent with DARZALEX in combination with pomalidomide and dexamethasone in these patients.
DARZALEX is the first CD38-directed antibody approved anywhere in the world. It was first approved by the FDA in November 2015 as a monotherapy treatment for patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double refractory to a PI and an immunomodulatory agent. It received additional approvals in November 2016 in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.
To date, approximately 16,000 patients have been treated with DARZALEX.
Despite tremendous progress, most patients with multiple myeloma continually relapse or become resistant to available therapies, such as PIs and immunomodulatory agents. Therefore, these patients continue to need new options,” said Ajai Chari M.D., Associate Professor of Medicine, Multiple Myeloma Program and Associate Director of Clinical Research, Mount Sinai Hospital. “With today’s approval of DARZALEX, we now have a promising new combination therapy that in clinical trials demonstrated pronounced clinical benefit for patients who have relapsed on two of the most widely used treatments.
This new indication for DARZALEX is supported by data from the Phase 1b EQUULEUS study, which showed that the combination of DARZALEX with pomalidomide and dexamethasone resulted in an ORR of 59.2 percent (95 percent CI: 49.1, 68.8), with very good partial response (VGPR) achieved in 28.2 percent of patients. Complete response (CR) was achieved in 5.8 percent of patients, stringent CR (sCR) was achieved in 7.8 percent of patients, and partial response (PR) was achieved in 17.5 percent of patients.1 The median time to response was one month (range: 0.9 to 2.8 months), and the median duration of response was 13.6 months (range: 0.9+ to 14.6+ months).
06/16/2017: FDA Approval