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In March 2022, Oncopeptides rescinded its prior letter asking for voluntary withdrawal of melphalan flufenamide in the U.S. In a press release, the company explained that further data review had led it to reconsider its previous withdrawal. However, it added that it would not seek to market the drug until it had reached a mutual understanding with the FDA.
The positive CHMP opinion for the drug was based on data from the Phase 2 HORIZON study and the Phase 3 OCEAN study, which was used as a confirmatory study.
On July 28, 2021, FDA released an alert warning of an increased risk of death associated with Pepaxto based on the OCEAN trial. FDA also required Oncopeptides to halt enrollment in the study.
FDA required the company to perform the OCEAN trial as a post-approval requirement for accelerated approval.
“The recommendation for full approval of Pepaxti by EMA is really good news for patients with triple class refractory disease, where the unmet medical need remains high, and treatment options often are exhausted,” said Dr. Pieter Sonneveld, principal investigator of the OCEAN study, in a press release.