Hus­tling to cap­ture top front­line NSCLC sta­tus, Roche scores a ‘break­through’ on Ale­cen­sa

The FDA has hand­ed Roche brag­ging rights to its sec­ond break­through drug des­ig­na­tion for Ale­cen­sa (alec­tinib), which is like­ly to help make the drug’s case as the new stan­dard for front-line treat­ment of ALK-pos­i­tive non-small cell lung can­cer.

BTDs are not in the least bit un­usu­al for big play­ers like Roche, which has now racked up a long string of them. But this one hits home, of­fer­ing ‘break­through’ sta­tus for this drug for pre­vi­ous­ly un­treat­ed pa­tients. Roche is fac­ing some ma­jor league com­pe­ti­tion on that score, and it won’t mind the added ben­e­fits a BTD of­fers in win­ning over reg­u­la­tors as well as in­flu­en­tial prac­ti­tion­ers.

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