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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