FDA/CDC

FDA approves anti-CD38 with VMP in myeloma

Publish date: May 8, 2018
By
Mary Ellen Schneider

 

The Food and Drug Administration has approved daratumumab (Darzalex) for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

The drug is approved in combination with a standard VMP regimen – bortezomib (Velcade), melphalan, and prednisone. The FDA had granted priority review to the drug application in January 2018 based on the results of the phase 3 ALCYONE study (NCT02195479).


Daratumumab, an anti-CD38 monoclonal antibody, reduced the risk of disease progression or death by 50%, compared with VMP alone in the ALCYONE study. The median progression-free survival had not yet been reached in the daratumumab arm; the median progression-free survival was 18.1 months in the VMP-only arm (N Engl J Med. 2018;378:518-28).

CD38 on the surface of multiple myeloma cells. Courtesy Janssen Biotech

CD38 on the surface of multiple myeloma cells.

Daratumumab is already approved as monotherapy for patients with multiple myeloma who have received at least three prior lines of therapy, and in combination with lenalidomide and dexamethasone (or bortezomib and dexamethasone) for patients who have received at least one prior therapy. It is approved in combination with pomalidomide and dexamethasone for patients who received at least two prior therapies.

Daratumumab is marketed by Janssen Biotech as Darzalex.

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