Oncopeptides’ Pepaxti wins positive opinion from CHMP for multiple myeloma patients

Oncopeptides AB (Nasdaq Stockholm:ONCO) has won a unanimous positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for Pepaxti (melphalan flufenamide) in the EU.

The European Commission will make a final decision on the drug candidate in the next 60 days.

An approval would make the drug available throughout the EU and in Iceland, Liechtenstein and Norway.

Stockholm-based Oncopeptides received FDA approval for the drug, marketed as Pepaxto, combined with dexamethasone for some adult patients with relapsed or refractory multiple myeloma on February 26, 2021.

Oncopeptides voluntarily withdrew the drug after the Phase 3 study on October 22, 2021, after analyzing data from the Phase 3 OCEAN study.

In March 2022, Oncopeptides rescinded its prior letter asking for voluntary withdrawal of melphalan flufenamide in the U.S. In a press release, the company explained that further data rev…

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