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EU Panel Backs Lorlatinib for ALK+ NSCLC

Jason M. Broderick @jasoncology
Published: Friday, Mar 01, 2019

Chris Boshoff, MD, PhD

Chris Boshoff, MD, PhD
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of lorlatinib (Lorviqua, EU; US, Lorbrena) for the treatment of adult patients with ALK-positive advanced non–small cell lung cancer (NSCLC) whose disease has progressed after alectinib (Alecensa) or ceritinib (Zykadia) as the first ALK TKI, or crizotinib and at least one other ALK TKI.

The CHMP recommendation is based on a nonrandomized, dose-ranging, multicohort, multicenter phase II study (B7461001) that included a subgroup of 215 patients with ALK-positive metastatic NSCLC previously treated with ≥1 ALK kinase inhibitors. The overall response rate with lorlatinib in these 215 patients was 48% (95% CI, 42-55), including a complete response rate of 4% and a partial response rate of 44%. The median duration of response was 12.5 months (95% CI, 8.4-23.7).

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