Shots:

• The approval is based on the P-II (PLEIADES) trial evaluates the clinical benefit of Darzalex Faspro + Kyprolis & dexamethasone (Kd) in patients with MM who have received 1-3 prior lines of therapy
• The trial met its 1EPs i.e., ORR (84.8%), 77.3% achieved a VGPR, median duration of follow-up of 9.2mos. while response rates with Darzalex Faspro & Kd were similar with Darzalex (IV) & Kd in the P-III (CANDOR) study. The safety profile was consistent with known safety profiles of Darzalex Faspro, carfilzomib & dexamethasone
• The approval marks the 9th indication for Darzalex Faspro. The therapy in combination with 3 SoC regimen used to treat newly diagnosed AL amyloidosis

Ref: PR Newswire | Image: Janssen