Novartis has received European approval for the expanded use of Zykadia in ALK advanced non-small cell lung cancer.
This follows a positive opinion granted in May by the Committee for Medicinal Products for Human Use (CHMP). It is applicable to all 28 European Union member states plus Iceland, Lichtenstein, and Norway.
The approval 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.
Patients treated with first-line Zykadia had a median progression-free survival (PFS) of 16.6 months (95%), compared to 8.1 months (95%) for patients treated with standard first-line pemetrexed-platinum chemotherapy with pemetrexed maintenance.
Overall intracranial response rate (OIRR) in patients with measurable brain metastases at baseline and at least one post-baseline assessment was 72.7% for patients treated with Zykadia, versus 27.3% for patients treated with chemotherapy.
In May, US Food and Drug Administration approved the expanded use of Zykadia to include the first-line treatment of patients with metastatic non-small cell lung cancer whose tumours are anaplastic lymphoma kinase-positive, as detected by an FDA-approved test.