Novartis receives EU approval for first-line use of Zykadia in ALK-positive advanced NSCLC

In ALK-positive advanced NSCLC patients, Zykadia demonstrated superior median progression-free survival compared with SOC chemotherapy with maintenance.

Novartis has 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 tumors are anaplastic lymphoma kinase (ALK)-positive. Approval follows a positive opinion granted in May by the Committee for Medicinal Products for Human Use (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, randomized, 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 with the chemotherapy arm. Patients treated with first-line Zykadia had a median progression-free survival (PFS) of 16.6 months, compared with 8.1 months 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. The whole body overall response rate (ORR) was 72.5% in patients treated with Zykadia.

Further, patients without brain metastases at screening receiving Zykadia experienced a median PFS of 26.3 months, compared with 8.3 months among patients treated with chemotherapy. Among patients with brain metastases at screening, the median PFS was 10.7 months in the Zykadia group, versus 6.7 months in the chemotherapy group.

"Today's EC approval of Zykadia as a first-line treatment of ALK+ non-small cell lung cancer is an important step forward for patients with this type of serious disease," said Bruno Strigini, CEO, Novartis Oncology. "Our commitment to innovation in lung cancer will continue and we look forward to providing additional advancements for patients as the incidence of the disease grows around the world."

In May, FDA approved the expanded use of Zykadia to include the first-line treatment of patients with NSCLC whose tumours are anaplastic lymphoma kinase (ALK)-positive, as detected by an FDA-approved test.