Mer­ck scores pri­or­i­ty re­view Keytru­da in squa­mous NSCLC; Syn­thet­ic Ge­nomics spin­out SGI-DNA gets new CEO

→ The FDA has ac­cept­ed — and giv­en pri­or­i­ty re­view — to Mer­ck’s sup­ple­men­tal bi­o­log­ics li­cense ap­pli­ca­tion for its can­cer im­munother­a­py Keytru­da. The phar­ma gi­ant is hop­ing the drug will be ap­proved in a new in­di­ca­tion: metasta­t­ic squa­mous non-small cell lung can­cer. This is Mer­ck’s an­ti-PD-1 ther­a­py, in com­bi­na­tion with car­bo­platin-pa­cli­tax­el or nab-pa­cli­tax­el as a first-line treat­ment. Mer­ck $MRK has been pour­ing bil­lions of dol­lars in­to its Keytru­da pipeline, and the in­vest­ment has paid off hand­some­ly with a block­buster fran­chise and a col­lec­tion of more than 750 tri­als — an ex­plo­sion of clin­i­cal re­search. For this lat­est in­di­ca­tion, the FDA gave Mer­ck a PDU­FA of Oc­to­ber 30, 2018.

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