Lung Cancer Drug Receives FDA Priority Review
Jennifer Barrett, Assistant Editor
The FDA has accepted Novartis’ supplemental new drug application (sNDA) for filing and granted priority review for the expanded use of a new cancer drug. Zykadia (ceritinib) is indicated as a first-line treatment for patients with metastatic non-small cell lung cancer (NSLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive.
Novartis’ submission for Zykadia’s first-line use is based on clinical trials that evaluated the safety and efficacy of the treatment compared to platinum-based chemotherapy in adult patients. The results found that patients treated with first-line Zykadia had a median progression-free survival of 16.6 months compared with 8.1 months in patients treated with chemotherapy.
The FDA has also granted breakthrough therapy designation to Zykadia for the first-line treatment of patients with ALK+ metastatic NSCLC with brain metastases.
The most common adverse events observed in the trial included diarrhea, mausea, vomiting, ALT increase, AST increase, gamma-glutamyltransferase increase, decreased appetite, blood alkaline phosphate increase, and fatigue.
Novartis drug Zykadia receives FDA Priority Review for first-line use in patients with ALK+ metastatic NSCLC [news release]. Basel. Novartis’ website. . Feb. 23, 2017.