Why wait? FDA gives ear­ly OK to Mer­ck’s Keytru­da for front­line lung can­cer

That didn’t take long.

Two weeks af­ter Mer­ck $MRK made a tri­umphant vic­to­ry march against Bris­tol-My­ers Squibb on the front­line non-small cell lung can­cer front at ES­MO, the FDA has fol­lowed up with a cru­cial ap­proval for the ear­ly use of its check­point in­hibitor Keytru­da.

The agency green-light­ed the use of Keytru­da among high ex­pressers of PD-L1, one of the key in­stru­ments that can­cer cells use to de­flect an at­tack by T cells. The FDA had set the PDU­FA date on this sBLA for Christ­mas Eve, but reg­u­la­tors are mov­ing much faster than the nor­mal time­lines per­mit when it comes to the es­tab­lished check­point drugs.

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