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FDA Approval: New Treatment Indication for Multiple Myeloma Drug

Rye Brook, N.Y., August 3, 2021 - The U.S. Food and Drug Administration (FDA) today announced approval of daratumumab plus hyaluronidase (Darzalex Faspro®) in combination with pomalidomide and dexamethasone (Pd) for the treatment of adults with multiple myeloma who have received at least one prior type of treatment, including lenalidomide (Revlimid®) and a proteosome inhibitor (Kyprolis®, Ninlaro®, Velcade®).

This is the first and only daratumumab formulation that can be delivered by subcutaneous injection; it can be administered in minutes rather than the hours necessary for intravenous administration. This is the sixth indication for daratumumab plus hyaluronidase in patients with multiple myeloma. It was first approved in 2015 and can be given alone or in combination with other drugs at different stages of treatment.

Daratumumab is a CD38-directed antibody. LLS supported early research into CD38 as a target in myeloma treatment beginning more than 15 years ago. LLS academic grant and venture philanthropy programs support both foundational research, including early work on the CD38 gene that underpins the success of daratumumab, and clinical studies that are moving effective treatments from the laboratory into clinical practice.

Multiple myeloma generally becomes resistant to all treatment eventually, meaning that patients will ultimately fail most, if not all, therapies. This makes it urgent that researchers continue to discover new treatments, and new combinations of treatments, that can slow disease progression after others have stopped working.

Today’s FDA approval was based on results from the phase 3 APOLLO study, which was presented at the American Society of Hematology (ASH) 2020 Annual Meeting. Participants who received daratumumab plus hyaluronidase with Pd had significantly reduced risk of disease progression or death by 37% compared to participants who received Pd alone. The median progression free survival was 12.4 months for patient treated with the triple combination compared to 6. 9 months for those who received only Pd.

The most common adverse drug reactions in patients treated with daratumumab plus hyaluronidase were fatigue, pneumonia, upper respiratory tract infection and diarrhea. Two percent of participants discontinued treatment due to adverse reactions and 7% had fatal adverse reactions.

LLS continues to invest in expansion of the use of CAR T-cell immunotherapy in myeloma by exploring ways to “supercharge” the body’s immune system to attack BCMA (B-cell maturation antigen), a protein found on the surface of myeloma cells, and we continue investing in research targeting CD38-expressing myeloma cells. LLS is also supporting the development of new therapies to prevent pre-myeloma conditions from advancing to myeloma.