Months after pulling only drug from US, Oncopeptides takes back withdrawal request — but stays mum on why
What happens when you pull a request to pull your drug from the market?
Oncopeptides is trying to find out, revealing late Friday that it has contacted the FDA and rescinded a letter it sent back in October, requesting voluntary withdrawal of the NDA of its multiple myeloma drug, Pepaxto, in the US — the only place where it’s approved.
The Stockholm-based biotech triggered a major meltdown with the announcement back in October, as the withdrawal would force it to close its US and EU business units and enact significant layoffs.
No details were given for the sudden change of mind. From a short, cryptic statement:
Further review and analyses of the heterogenous Overall Survival data from the phase 3 OCEAN study and other relevant trials have led the Company to reconsider its previous voluntary withdrawal request.
At the time, it seemed like Oncopeptides had little choice; Pepaxto, or melphalan flufenamide, first won accelerated approval in early 2021 as a treatment for relapsed or refractory multiple myeloma. But then in July, investigators reported that the drug had failed the overall survival endpoint in a confirmatory study that pit it against Bristol Myers Squibb’s Pomalyst — in fact, the risk of death was higher for patients on the Pepaxto arm.
The FDA quickly followed up with an alert to patients and healthcare providers about the safety concern, and convened an adcomm to weigh in.
But Oncopeptides stopped that discussion from happening by pulling the drug days before the panel of outside experts were set to meet.
Having stopped the marketing of Pepaxto in the US, the company says it has no plans to restart “at this time.” What it will do, though, is initiate a dialogue with the FDA to review the new data.