Roche scores a suc­cess for Ale­cen­sa PhI­II; FDA sched­ules Ad­Comm for Hep­lisav-B; New CMO at Sarep­ta

Roche re­port­ed this morn­ing that its lat­est Phase III study for Ale­cen­sa (alec­tinib) came through, hit­ting the end­point on pro­gres­sion-free sur­vival for non-small cell lung can­cer pa­tients who had failed chemo com­bined with crizo­tinib. “We are pleased to an­nounce that the re­sults of the phase III ALUR tri­al fur­ther sup­port the use of Ale­cen­sa as a treat­ment for peo­ple with ALK-pos­i­tive lung can­cer who, af­ter hav­ing pro­gressed on both chemother­a­py and crizo­tinib, are in need of new treat­ment op­tions,” said San­dra Horn­ing, Chief Med­ical Of­fi­cer and Head of Glob­al Prod­uct De­vel­op­ment. “The re­sults of this tri­al will sup­port our ac­cess dis­cus­sions with glob­al health au­thor­i­ties as we seek to bring Ale­cen­sa to pa­tients faster.”

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