Posted by Michael Wonder on 29 Jun 2017
Novartis receives EU approval for first-line use of Zykadia in ALK positive advanced non-small-cell lung cancer
29 June 2017 - Zykadia benefit was also seen in patients with brain metastases.
Novartis today announced the European Commission approved expanding the use of Zykadia (ceritinib) to include the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumours are anaplastic lymphoma kinase (ALK)-positive. Approval follows a positive opinion granted in May by the CHMP, and is applicable to all 28 European Union member states plus Iceland, Lichtenstein, and Norway.
The first-line approval of Zykadia is based on results from an open-label, randomised, multicenter, global, Phase III trial, ASCEND-4. The study met its primary endpoint, demonstrating a 45% reduction in the risk of disease progression in the Zykadia arm, compared to the chemotherapy arm (hazard ratio [HR] = 0.55 [95% confidence interval (CI): 0.42, 0.73; one-sided p value <0.0001])[1]. Patients treated with first-line Zykadia had a median progression-free survival (PFS) of 16.6 months (95% CI: 12.6, 27.2), compared to 8.1 months (95% CI: 5.8, 11.1) for patients treated with standard first-line pemetrexed-platinum chemotherapy with pemetrexed maintenance.
