Ceritinib Granted Priority Review for ALK-Positive Metastatic NSCLC
The FDA has granted Priority Review for the expanded use of ceritinib as first-line therapy for patients with metastatic NSCLC whose tumors are anaplastic lymphoma kinase (ALK)-positive. Ceritinib was also granted Breakthrough Therapy designation for the first-line treatment of patients with ALK+ metastatic NSCLC and metastases to the brain.
These decisions were based on the primary analysis of ASCEND-4, a global phase 3 multicenter clinical trial that evaluated safety and efficacy of ceritinib compared with platinum-based chemotherapy in adult patients with stage IIIB or IV ALK+ NSCLC.
In ASCEND-4, patients treated with first-line ceritinib had a median progression-free survival (PFS) of 16.6 months compared with 8.1 months for patients treated with standard first-line pemetrexed-platinum chemotherapy, with pemetrexed maintenance.
In a pre-specified analysis of patients without brain metastases at screening who received ceritinib, median PFS was 26.3 months compared with 8.3 months among those treated with chemotherapy. Likewise, in a pre-specified analysis of patients with brain metastases at baseline who received ceritinib, median PFS was 10.7 months versus 6.7 months in the chemotherapy group.
The most common adverse events among patients who received ceritinib were diarrhea, nausea, vomiting, increased ALT /AST, increased gamma-glutamyl transferase, decreased appetite, increased blood alkaline phosphate, and fatigue.