Roche wins speedy FDA re­view for Tecen­triq; South Ko­re­an au­thor­i­ties to look in­to Sam­sung Bi­o­Log­ics ac­count­ing prac­tices

→ Trail­ing be­hind im­munother­a­py of­fer­ings from Mer­ck $MRK and Bris­tol-My­ers Squibb $BMY, Roche $RHH­BY has been plot­ting to se­cure ap­proval of its Tecen­triq for dif­fi­cult-to-treat can­cers. On Tues­day, the Swiss drug­mak­er an­nounced the FDA had agreed to an ac­cel­er­at­ed re­view of Tecen­triq in com­bi­na­tion with the chemother­a­py Abrax­ane for ini­tial treat­ment of metasta­t­ic triple-neg­a­tive breast can­cer with tu­mors that test pos­i­tive for the pro­tein PD-L1. The pri­or­i­ty re­view des­ig­na­tion means the FDA is ex­pect­ed to make a de­ci­sion on the drug by March 12, 2019, Roche said.

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