EU CHMP recommends expanding approval of Zykadia (ceritinib) to include first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive- Novartis

Novartis announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of expanding the use of Zykadia (ceritinib) to include the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive. If approved, Zykadia will provide a new treatment option for previously untreated and newly diagnosed patients with ALK-positive advanced NSCLC.

The positive CHMP opinion was based on results from the ASCEND-4 study, a randomized, open-label, global Phase III trial. The study showed that patients treated with first-line Zykadia experienced a 45% reduction in the risk of disease progression compared to patients treated with standard first-line pemetrexed-platinum chemotherapy with pemetrexed maintenance. The median progression-free survival (PFS) was 16.6 months for patients receiving Zykadia compared to 8.1 months for patients in the chemotherapy arm of the study.

Additionally, patients receiving Zykadia without brain metastases at baseline experienced a median PFS of 26.3 months, compared with 8.3 months among patients treated in the chemotherapy arm. Among patients with brain metastases at baseline, the median PFS was 10.7 months in the Zykadia group versus 6.7 months in the chemotherapy group. Of these patients, 59% did not receive prior brain radiotherapy. The high intracranial overall response rate (ORR) (72.7%) was consistent with whole body ORR (72.5%).