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 The priority review covers expanded use of Zykadia (ceritinib) for
patients with metastatic non-small cell lung cancer (NSCLC) whose
tumors are anaplastic lymphoma kinase (ALK)-positive, it said.
The FDA also granted breakthrough therapy designation to Zykadia for
the first-line treatment of patients with ALK+ metastatic NSCLC with
metastases to the brain.
Novartis AG had said in December that Zykadia was twice as effective
as chemotherapy in slowing the progression of the rare form of lung
cancer in a late-stage study.
The drug competes with Roche Holding AG's Alecensa, which is widely
seen to have a leg up in the race to secure regulatory approval as a
first-line treatment.
ALK+ non-small cell lung cancer affects between 2 and 7 percent of
roughly 1.8 million new lung cancer cases reported annually.
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(Reporting by Michael Shields; editing by Jason Neely)
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