J&J wins another FDA label expansion for multiple myeloma therapy

Johnson & Johnson (NYSE:JNJ) has received FDA approval to market Darzalex Faspro, an antibody therapy it developed with Genmab (GMAB) and Halozyme (NASDAQ:HALO), for another group of patients with multiple myeloma, a form of blood cancer.

The latest decision allows its use in combination with some other cancer drugs for newly diagnosed patients with multiple myeloma who are not eligible for autologous stem cell transplant, the company said.

The New Jersey-based pharma giant added that the approval marks the ninth indication that the subcutaneously delivered CD38-directed antibody is approved in the U.S. for multiple myeloma.

The FDA based its decision on the company’s ongoing Phase 3 PERSEUS study, which reached the primary endpoint, with a statistically significant improvement in progression-free survival.

According to findings from PERSEUS, those who received Darzalex Faspro, with a drug combination comprising bortezomib, lenalidomide, and dexamethasone (D-VRd), indicated a 60% decline in the risk of disease progression or death compared to those on VRd alone.