FDA scientists set date to discuss next steps for Pepaxto

An upcoming meeting of the US regulator’s Oncologic Drugs Advisory Committee (ODAC) will discuss the benefit/risk profile of Oncopeptides’ (STO: ONCO) Pepaxto (melphalan flufenamide).

The Swedish blood disorder specialist has previously  changed its mind about voluntarily withdrawing its New Drug Application (NDA) for Pepaxto, after studying overall survival (OS) data from the Phase III OCEAN study.

Pepaxto was approved under the US Food and Drug Administration’s accelerated approval scheme as a later-line option for people with multiple myeloma.