Re­gen­eron and Sanofi pull Lib­tayo app in cer­vi­cal can­cer, cit­ing post-mar­ket study dis­agree­ment with FDA

Sanofi and Re­gen­eron on Fri­day said they’ve de­cid­ed to pull their sBLA for their PD-1 Lib­tayo (cemi­plimab-rwlc) in sec­ond-line cer­vi­cal can­cer af­ter the com­pa­nies and the FDA were not able to align on cer­tain post-mar­ket­ing stud­ies that pre­sum­ably would’ve been re­quired had it won ap­proval.

Nei­ther Sanofi nor Re­gen­eron was will­ing to elab­o­rate on this dis­con­nect over the post-mar­ket­ing re­quire­ments, but talks with reg­u­la­tors out­side the US re­main on­go­ing.

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