FDA Grants First-Line Approval to Zykadia in ALK-Positive NSCLC

The FDA approved Zykadia (ceritinib), developed by Novartis, for metastatic non-small cell lung cancer patients whose tumors are ALK-positive as detected by an FDA-approved companion diagnostic test.

In April 2014, Zykadia received accelerated approval for ALK-positive metastatic NSCLC whose disease has progressed or who are intolerant to crizotinib.

The new approval is based on data from a Phase III trial in patients with untreated disease. All patients were required to have evidence of ALK gene rearrangement identified by the Ventana ALK (D5F3) test.

The trial doubled progression-free survival to an estimated median of 16.6 months with Zykadia compared to 8.1 months with chemotherapy.