Janssen’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) + Pomalidomide and Dexamethasone Receive the US FDA’s Approval to Treat Patients with Multiple Myeloma

July 13, 2021 Auto Bot approval, daratumumab, FDA, Janssen, multiple myeloma, regulatory 0

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

Click here to read full press release/ article | Ref: PR Newswire | Image: Shutterstock

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