The U.S. Food and Drug Administration approved Novartis AG's Zykadia as a first-line treatment for patients with a specific type of lung cancer.
The drug was already approved for anaplastic lymphoma kinase-positive, metastatic non-small cell lung cancer patients that failed treatment with Pfizer Inc.'s Xalkori.
The U.S. FDA expanded the use of Zykadia based on the results of a phase 3 trial in patients who received no prior treatment. The study showed a median progression-free survival rate of 16.6 months as opposed to the 8.1 months achieved by those on standard, first-line pemetrexed-platinum chemotherapy with pemetrexed maintenance.