FDA Approves Novartis’s Zykadia For Type of Late-Stage Lung Cancer

The Food and Drug Administration April 29 granted accelerated approval to Zykadia (ceritinib) for patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC).

Zykadia, which is made by Novartis, is an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor that blocks proteins that promote the development of cancerous cells, the agency said. It is intended for patients with metastatic ALK-positive NSCLC who previously were treated with crizotinib, the only other approved ALK tyrosine kinase inhibitor. Novartis is based in Switzerland.

Breakthrough Therapy Status.

Zykadia is the fourth drug with breakthrough therapy designation to receive FDA approval, the ...