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High-Stakes Meeting With EMA On The Cards For Oncopeptides’ Pepaxto

 
• By Neena Brizmohun

Oncopeptides is nearing the end of the regulatory review cycle in the EU for its multiple myeloma drug, melphalan flufenamide. The product has had an erratic journey in the US, where it was approved but then withdrawn, and the withdrawal was subsequently rescinded.

Multiple myeloma (cancer type) diagnosis medical concept on tablet screen with stethoscope.
Oncopeptides is seeking EU marketing for Pepaxto for multiple myleoma • Source: Alamy

Oncopeptides may today present before the European Medicines Agency to explain why the regulator should recommend in favor of EU marketing approval for its multiple myeloma drug melphalan flufenamide, which has had a bumpy ride in the US following its approval there last year under the brand name Pepaxto.

The company was listed as being possibly due to speak at an oral explanation meeting this afternoon, according to the draft meeting

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