FDA gives pri­or­i­ty re­view to new Keytru­da sBLA; As­traZeneca's Pearl signs asth­ma de­vel­op­ment pact with Avil­lion

→ The FDA is giv­ing pri­or­i­ty re­view to Mer­ck’s $MRK an­ti-PD-1 ther­a­py, Keytru­da, for a new sup­ple­men­tal bi­o­log­ics li­cense ap­pli­ca­tion (sBLA). The ap­pli­ca­tion is ask­ing for an OK to use Keytru­da as a treat­ment for cer­vi­cal can­cer pa­tients whose can­cer has pro­gressed while on (or af­ter) chemother­a­py. The sBLA is based in part on da­ta from the com­pa­ny’s Phase II KEYNOTE-158 tri­al, ac­cord­ing to a Mer­ck state­ment. The FDA set a PDU­FA date of June 28, 2018.

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