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.
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. https://www.novartis.com/news/media-releases/novartis-drug-zykadia-receives-fda-priority-review-first-line-use-patients-alk. Feb. 23, 2017.