Oncopeptides AB’s appeal of the US FDA drugs center proposal to withdraw accelerated approval for the multiple myeloma drug Pepaxto (melphalan flufenamide, or melflufen) will be the first measure of the speed offered by new expedited withdrawal procedures.
How Fast Is ‘Expedited’? Pepaxto To Show Speed Of New Withdrawal Process For Accelerated Approval Drugs
For the Pepaxto appeal to be wrapped up on a faster timeline than Genentech’s dispute with the US FDA drugs center over Avastin’s breast cancer claim, CBER Director Peter Marks, the commissioner’s designee, would have to render a final decision before January 2024.
