Weeks af­ter Keytru­da CRL in high-risk TNBC, Mer­ck claims a win af­ter da­ta ma­ture. How soon will it re­turn to FDA?

There’s been much afoot re­gard­ing Mer­ck’s at­tempts to ex­pand its block­buster Keytru­da drug in­to high-risk, ear­ly-stage triple-neg­a­tive breast can­cer so far in 2021.

In ear­ly Feb­ru­ary, well af­ter Mer­ck had sub­mit­ted its sup­ple­men­tal BLA for the in­di­ca­tion, the FDA’s ODAC unan­i­mous­ly re­buked the phar­ma’s pitch, say­ing the da­ta were too im­ma­ture to be con­clu­sive. FDA can­cer czar Richard Paz­dur took the ex­tra­or­di­nary step of ad­mon­ish­ing Mer­ck dur­ing the meet­ing, say­ing the com­pa­ny should not have as­sumed or hoped for a pos­i­tive re­sult be­fore the piv­otal study read out. A few weeks lat­er, reg­u­la­tors un­sur­pris­ing­ly hand­ed Mer­ck a com­plete re­sponse let­ter.

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