FDA Grants Priority Review to Lorlatinib in ALK-Positive NSCLC

On February 12, the U.S. Food and Drug Administration (FDA) accepted and granted Priority Review to Pfizer’s new drug application for lorlatinib. The Prescription Drug User Fee Act goal date for a decision by the FDA is in August 2018.

Lorlatinib is an investigational, anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor for the treatment of patients with ALK-positive metastatic non–small cell lung cancer (NSCLC) previously treated with one or more ALK tyrosine kinase inhibitors. It has been shown to be highly active in preclinical lung cancer models harboring chromosomal rearrangements of both ALK and ROS1. Lorlatinib was specifically designed to inhibit tumor mutations that drive resistance to other ALK inhibitors and to penetrate the blood-brain barrier.

The European Medicines Agency and the Japan Pharmaceutical and Medical Devices Agency have also accepted marketing applications for the use of lorlatinib.

In April 2017, lorlatinib received Breakthrough Therapy designation from the FDA for patients with ALK-positive metastatic NSCLC previously treated with one or more ALK inhibitors.

Phase I/II Trial Data

The submissions are based on phase II data from a phase I/II clinical trial of lorlatinib evaluating patients treated in distinct cohorts based on prior therapy.

Full results from the phase II portion of the trial were presented in October 2017 by Solomon et al at the International Association for the Study of Lung Cancer 18th World Conference on Lung Cancer. 

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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