Last re­sort: On­copep­tides for­mal­ly chal­lenges FDA's with­draw­al of can­cer drug's ac­cel­er­at­ed ap­proval

The FDA’s new, ex­pe­dit­ed process around ac­cel­er­at­ed ap­proval with­drawals will be put to its first test with On­copep­tides’ 2021 ac­cel­er­at­ed ap­proval of Pepax­to (mel­pha­lan flufe­namide), which first won ap­proval as a fifth-line ther­a­py for the blood can­cer known as mul­ti­ple myelo­ma, but failed its con­fir­ma­to­ry tri­al.

The Swedish biotech said in its earn­ings yes­ter­day that the chal­lenge at FDA fol­lows its re­ceipt last month of the agency’s for­mal re­quest to vol­un­tar­i­ly with­draw the ap­proval.

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