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

By Brian Buntz | June 23, 2022

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In March 2022, Oncopeptides rescinded its prior letter asking for voluntary withdrawal of melphalan flufenamide in the U.S. In a press release, the company explained that further data review had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

 


Filed Under: Oncology
Tagged With: EMA, European Medicines Agency, melphalan flufenamide, Oncopeptides, Pepaxti, Pepaxto
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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