Roche's PD-L1 fran­chise play­er nabs pri­or­i­ty re­view; One of world's first psy­che­delics re­search in­sti­tutes opens in Aus­tralia

The FDA has just put Genen­tech’s lat­est shot at adding block­buster sales for Tecen­triq on the reg­u­la­tor’s in­side track.

Roche said Tues­day that the agency has pro­vid­ed pri­or­i­ty re­view sta­tus for a sup­ple­men­tal NDA to get the big PD-L1 fran­chise play­er ap­proved for ad­ju­vant treat­ment fol­low­ing surgery and plat­inum-based chemother­a­py for peo­ple with non-small cell lung can­cer.

Genen­tech re­searchers came up with the first ev­i­dence of dis­ease-free sur­vival for the drug fol­low­ing surgery and plat­inum-based chemother­a­py. The drug re­duced the risk of dis­ease re­cur­rence or death by 34%, mak­ing it a like­ly win­ner even be­fore the Dec. 1 PDU­FA date.

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