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FDA Approves New Treatment Option for Patients with Multiple Myeloma at First or Subsequent Relapse

Rye Brook, N.Y., December 1, 2021 – The U.S. Food and Drug Administration (FDA) recently granted the seventh approval to daratumumab for the treatment of multiple myeloma. This injectable antibody is approved alone or in combination with other drugs at different states of multiple myeloma treatment.

This is also the fourth FDA approval for a new multiple myeloma drug this year and is welcome news in the fight against myeloma, the second most common U.S. blood cancer. Myeloma is among LLS’s primary research initiatives with more than 30 active laboratory and clinical projects – a $30 million commitment. LLS is committed to identifying mutations that cause myeloma, understanding therapeutic resistance to the disease and preventing pre-myeloma from advancing to myeloma. 

The latest approval is for the combination of daratumumab plus hyaluronidase-fijh (Darzalex Faspro) plus carfilzomib (Kyprolis) and the steroid dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who received one to three prior treatments. Treatment combinations that include daratumumab plus hyaluronidase can be administered subcutaneously in a fraction of the time it takes to administer the older intravenous formulations.

The approval was based on the PLEIADES clinical trial, which included 66 patients with relapsed/refractory myeloma who had at least one prior treatment and were given the three-drug combination. The overall response rate, which is the percentage of patients whose disease responded to the treatment was 84.8%. Researchers reported that more than 80% of these patients had a response that lasted at least to the 9.2 month follow up mark.

The most common side effects, occurring in at least 20% of the study participants were respiratory tract infections, fatigue, insomnia, high blood pressure, diarrhea, cough, difficulty breathing, headache, fever, nausea and edema peripheral (swelling in the legs and hands).