publication date: Jun. 2, 2017

Drugs and Targets

Zykadia gets first-line ALK-positive metastatic NSCLC indication

FDA approved the expanded use of Zykadia (ceritinib) to include the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors are anaplastic lymphoma kinase-positive, as detected by an FDA-approved test.

The drug is sponsored by Novartis. Zykadia first received accelerated approval in 2014 for patients with ALK-positive metastatic NSCLC who progressed on or are intolerant to crizotinib. In January, FDA granted Zykadia Breakthrough Therapy designation for the first-line treatment of patients with ALK-positive metastatic NSCLC with metastases to the brain, and Priority Review for first-line ALK-positive metastatic NSCLC.

The first-line approval of Zykadia is based on results from an open-label, randomized, multicenter, global, phase III trial, ASCEND-4. ASCEND-4 is a phase III randomized, open-label, multicenter, global clinical trial to evaluate the safety and efficacy of Zykadia compared to standard chemotherapy, including maintenance, in adult patients with Stage IIIB or IV ALK-positive advanced NSCLC who received no prior therapy for their advanced disease.

The study demonstrated that patients treated with first-line Zykadia had a median progression-free survival of 16.6 months (95% confidence interval: 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 was 57% (95% CI: 37, 76; n = 28) for patients treated with Zykadia, versus 22% (95% CI: 9, 42; n = 27) for patients treated with chemotherapy. The whole body overall response rate was 73% (95% CI: 66, 79; n = 187) in patients treated with Zykadia.

Patients received Zykadia orally at 750 mg/daily or standard pemetrexed-based platinum doublet chemotherapy … Continue reading Zykadia gets first-line ALK-positive metastatic NSCLC indication

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