Experimental ALK Inhibitor Gains FDA Priority Review Designation for Lung Cancer

Lorlatinib was designed to bypass non-small cell lung cancer mutations that promote drug resistance

Pfizer announced this week that the FDA has accepted a new drug application for lorlatinib, an investigational anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI).

The experimental drug is being explored as a treatment for patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) who were previously treated with at least 1 ALK TKI, according to a company press release.

Pfizer announced that the European Medicines Agency and the Japan Pharmaceutical and Medical Devices Agency also accepted applications for review.

The new submissions are based on positive findings from phase 2 and phase 1/2 clinical trials of lorlatinib, which evaluated patients in cohorts based on previous therapies, according to the release.

Lorlatinib has been observed to be active in preclinical models of lung cancer that have ALK and ROS1 mutations. The experimental drug was specifically designed to block tumor mutations known to cause drug resistance and to cross the blood-brain barrier, according to the release.

“Treatment resistance resulting in disease progression is a major challenge faced by patients with ALK-positive metastatic NSCLC. Lorlatinib was developed by Pfizer scientists with the specific goal of overcoming resistance to first- and second-generation ALK-targeted therapies,” said Mace Rothenberg, MD, chief development officer, Oncology, Pfizer Global Product Development. “The encouraging results observed in a variety of patients previously treated with ALK inhibitors provides the basis for these applications.”