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FDA Grants Priority Review to Lorlatinib for ALK+ NSCLC

Jason Harris
Published: Monday, Feb 12, 2018

Dr. Mace Rothenberg

Mace Rothenberg, MD
The FDA has granted a priority review to a new drug application (NDA) for lorlatinib for use in patients with ALK-positive metastatic non–small cell lung cancer (NSCLC) who have progressed on 1 or more ALK tyrosine kinases inhibitors (TKIs).

No prior systemic treatment for NSCLC is allowed. Patients must have an ECOG performance status of 0, 1, or 2. Patients cannot enroll if they have had radiation therapy—including stereotactic or partial brain irradiation—within 2 weeks of randomization, or whole brain irradiation within 4 weeks of randomization. The primary outcome measure is progression-free survival. Secondary endpoints include overall survival, ORR, IC-ORR, time to tumor response, and safety.
Solomon BJ, Shaw A, Ignatius Ou S-H, et al. Phase 2 Study of lorlatinib in patients with advanced ALK+/ROS1+ non-small-cell lung cancer. Presented at: the IASLC 18th World Conference on Lung Cancer; October 15-18; Yokohama, Japan. Abstract 8573.

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