The agency approved the drug for ALK-positive non-small cell lung cancer among patients already treated with Xalkori (crizotinib)
The FDA's approval of Zykadia marks a new chapter in cancer drug development.
Investigators for the pharma giant recently reported that in a group of 114 ALK-positive lung cancer patients taking a daily dose ranging up from 400 mg, investigators tracked a 58% overall response that included complete and partial responses and a median progression-
An early approval like this could also encourage other developers to shoot for accelerated approval in cancer. Pfizer, which is now focused on a megamerger with AstraZeneca, has been studying its chances with the breast cancer drug palbociclib. And Novartis has also been hinting recently that it may take the plunge on Phase II data for LDE225, an oral therapy for basal cell carcinoma.
Novartis didn't miss the chance of celebrating its effectiveness in the cancer drug field, an arena that is slated to soon swell as it swaps out its vaccines business for GlaxoSmithKline's oncology drugs--along with rights to its AKT inhibitor afuresertib--
"The approval of Zykadia less than three and a half years after the first patient entered our clinical trial exemplifies what is possible with a highly focused approach to drug development and strong collaboration,"
"Today's approval illustrates how a greater understanding of the underlying molecular pathways of a disease can lead to the development of specific therapies aimed at these pathways," said Pazdur in a statement. "It also demonstrates the FDA's commitment to working cooperatively with companies to expedite a drug's development, review and approval, reflecting the promise of the breakthrough therapy designation program."
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