Novartis’s cancer drug wins FDA’s sNDA, priority review and breakthrough therapy designation

US Food and Drug Administration (FDA) has accepted Novartis’s supplemental New Drug Application (sNDA) for filing, and granted Priority Review for the expanded use of Zykadia (ceritinib) as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.

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. This is the second Breakthrough Therapy designation for Zykadia.

The sNDA submission for first-line use of Zykadia is based on the study conducted at 134 clinical trial sites across 28 countries, and randomized across 376 patients.

Since the application has been granted priority review, FDA will take action within 6 months of submission instead of 10 months under standard review timelines.

According to WHO, worldwide, lung cancer causes more deaths than colon, breast and prostate cancer combined, and an estimated 1.8 million new cases of lung cancer are diagnosed each year.