FDA OKs Darzalex immunotherapy for multiple myleoma patients

Janssen Biotech's Darzalex immunotherapy was approved by the U.S. Food and Drug Administration.
Janssen Biotech's Darzalex immunotherapy was approved by the U.S. Food and Drug Administration. | Contributed image

Janssen Biotech's Darzalex immunotherapy was approved by the U.S. Food and Drug Administration for treating patients with multiple myeloma in combination with pomalidomide and dexamethasone.

“Despite tremendous progress, most patients with multiple myeloma continually relapse or become resistant to available therapies, such as PLS and immunomodulatory agents. Therefore, these patients continue to need new options,” Dr. Ajai Chari, associate professor of medicine at the Multiple Myeloma Program and Associate Director of Clinical Research at Mount Sinai Hospital, said in a statement. “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.”

The drug is specifically for those patients who have received at least two prior types of therapies – immunomodulatory agent lenalidomide and a proteasome inhibitor. Darzalex is administered as an intravenous infusion and its dosage depends on patient body weight.

“The recent approval of DARZALEX is significant for patients and clinicians who urgently need new options and regimens. This milestone underscores the versatility of DARZALEX with a range of treatment regimens,” Dr. Peter Lebowitz, global oncology head for Janssen Research & Development, said. “We look forward to continued study of daratumumab in earlier stages of multiple myeloma and other cancers.”

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Janssen Biotech, Inc. 800 Ridgeview Dr Horsham, PA - 19044