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.
Sandra Horning hammered the frontline point in a statement. She said:
“The J-ALEX study that supports the second Breakthrough Designation for Alecensa showed superior efficacy versus the standard of care, crizotinib (Xalkori), in Japanese people with advanced ALK-positive disease. The decision by the FDA to grant a second breakthrough therapy designation is recognition of the clinically meaningful improvement in efficacy and safety that Alecensa brings to the care of people with advanced ALK-positive lung cancer who have not received prior treatment with an ALK inhibitor.”
A couple of weeks ago Novartis outlined plans to hustle to regulators with new late-stage data on their cancer drug Zykadia (certinib), looking for an approval to move up to first-line treatment of ALK-positive non-small cell lung cancer. Investigators say the drug outperformed standard chemo in previously untreated patients for progression-free survival. There were also “clinically meaningful” improvements in the overall response rate and duration of response, though that will need to be clarified when the data is released.
Novartis is looking to considerably enhance its market for this drug, given an accelerated approval two years ago as a second-line therapy.
Late last year the FDA handed out an accelerated first approval to use Alecensa for patients who had seen their disease progress while on Xalkori.
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