European Commission Expands Use of Ceritinib for First-Line Use in ALK-Positive Advanced NSCLC

On June 29, the European Commission approved expanding the use of ceritinib (Zykadia) 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, and is applicable to all 28 European Union member states plus Iceland, Lichtenstein, and Norway.

In May, the U.S. Food and Drug Administration (FDA) approved the expanded use of ceritinib to include the first-line treatment of patients with metastatic NSCLC whose tumors ALK-positive as detected by an FDA-approved test.


The first-line approval of ceritinib 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 ceritinib arm, compared to the chemotherapy arm (hazard ratio [HR] = 0.55; 95% confidence interval [CI] = 0.42–0.73; one-sided P value < .0001).Patients treated with first-line ceritinib had a median progression-free survival 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.

Overall intracranial response rate in patients with measurable brain metastases at baseline and at least one post-baseline assessment was 72.7% (95% CI = 49.8–89.3; n = 22) for patients treated with ceritinib vs 27.3% (95% CI = 10.7–50.2; n = 22) for patients treated with chemotherapy. The overall response rate (ORR) was 72.5% (95% CI = 65.5–78.7; n = 189) in patients treated with ceritinib.

Further, patients without brain metastases at screening receiving ceritinib experienced a median progression-free survival of 26.3 months (95% CI = 15.4–27.7), compared with 8.3 months (95% CI = 6.0–13.7) among patients treated with chemotherapy (HR = 0.48; 95% CI = 0.33–0.69). Among patients with brain metastases at screening, the median progression-free survival was 10.7 months (95% CI = 8.1–16.4) in the ceritinib group vs 6.7 months (95% CI = 4.1–10.6) in the chemotherapy group (HR = 0.70; 95% CI = 0.44–1.12).

“Today’s European Commission approval of ceritinib as a first-line treatment of ALK-positive non–small cell lung cancer is an important step forward for patients with this type of serious disease,” said Bruno Strigini, CEO, Novartis Oncology.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.




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