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.
Ref: PRNewswire | Image: Cowen
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