FDA bars the door — for now — against Mer­ck’s star can­cer drug af­ter Roche beat them to the punch

Mer­ck has been hand­ed a rare set­back at the FDA.

Af­ter fil­ing for the ac­cel­er­at­ed ap­proval of a com­bi­na­tion of their star PD-1 drug Keytru­da with Ei­sai’s Lenvi­ma as a first-line treat­ment for un­re­sectable he­pa­to­cel­lu­lar car­ci­no­ma, the FDA nixed the move, hand­ing out a CRL be­cause Roche beat them to the punch on the same in­di­ca­tion by a mat­ter of weeks.

Ac­cord­ing to Mer­ck:

Ahead of the Pre­scrip­tion Drug User Fee Act ac­tion dates of Mer­ck’s and Ei­sai’s ap­pli­ca­tions, an­oth­er com­bi­na­tion ther­a­py was ap­proved based on a ran­dom­ized, con­trolled tri­al that demon­strat­ed over­all sur­vival. Con­se­quent­ly, the CRL stat­ed that Mer­ck’s and Ei­sai’s ap­pli­ca­tions do not pro­vide ev­i­dence that Keytru­da in com­bi­na­tion with Lenvi­ma rep­re­sents a mean­ing­ful ad­van­tage over avail­able ther­a­pies for the treat­ment of un­re­sectable or metasta­t­ic HCC with no pri­or sys­temic ther­a­py for ad­vanced dis­ease. Since the ap­pli­ca­tions for KEYNOTE-524/Study 116 no longer meet the cri­te­ria for ac­cel­er­at­ed ap­proval, both com­pa­nies plan to work with the FDA to take ap­pro­pri­ate next steps, which in­clude con­duct­ing a well-con­trolled clin­i­cal tri­al that demon­strates sub­stan­tial ev­i­dence of ef­fec­tive­ness and the clin­i­cal ben­e­fit of the com­bi­na­tion.

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