Zykadia Wins FDA Priority Review in First-Line Metastatic NSCLC

Novartis has gained FDA Priority Review for the expanded use of Zykadia as a first-line treatment for patients with metastatic non-small cell lung cancer whose tumors are anaplastic lymphoma kinase-positive as detected by an FDA-approved test.

The FDA also granted a Breakthrough Therapy designation to Zykadia for the first-line treatment of patients with ALK+ metastatic NSCLC with brain metastases.