Shots:

• The approval is based on P-III APOLLO study evaluating Darzalex Faspro (SC) + pomalidomide & dexamethasone (Pd) vs Pd alone in 304 patients with RRMM who have received at least one prior treatment regimen including lenalidomide & a proteasome inhibitor
• The study met its 1EPs of PFS & showed 37% reduction in risk of progression or death- m-PFS (12.4 vs 6.9mos.)- ORR (69% vs 46%)- CR (25% vs 4%) & VGPR (51% vs 20%)- patients with negative status for MRD (9% vs 2%)
• 2% of patients discontinued treatment permanently due to AEs. Darzalex Faspro is the 1st SC CD38-directed Ab for MM & AL amyloidosis. The approval marks the 6th indication for Darzalex Faspro to treat MM

  Ref: PR Newswire | Image: Janssen