ZURICH (Reuters) - The U.S. Food and Drug Administration (FDA) has granted priority review to Novartis drug Zykadia as a first-line treatment for some lung cancer patients, the Swiss drugmaker said on Thursday.
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.
Reporting by Michael Shields; editing by Jason Neely
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