Oncopeptides’ Pepaxto (melphalan flufenamide) Receives the US FDA’s Approval for Triple Class Refractory Multiple Myeloma

Shots:

• The approval is based on P-II HORIZON study assessing Pepaxto + dexamethasone in 157 patients with r/r MM who have received at least prior 4L of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed mAb
• The P-II HORIZON study resulted in 23.7 % ORR with 4.2mos. median DoR. Of the subset of 97 patients, 41% had EMD
• Pepaxto is the first anticancer peptide-drug conjugate approved in multiple myeloma. The company expects Papexto to be commercially available in the US within ~2wks.

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Cowen