FDA, EMA, Japan reviewing Pfizer's lorlatinib for NSCLC

Pfizer Inc. (NYSE:PFE) said FDA accepted and granted Priority Review to an NDA for lorlatinib (PF-06463922) to treat anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) in patients previously treated with one or more ALK tyrosine kinase inhibitors (TKIs). The PDUFA date is in August.

The pharma also said Monday that EMA and Japan's Pharmaceutical and Medical Devices Agency (PMDA) have accepted for review applications for lorlatinib.

In the U.S., lorlatinib has breakthrough therapy designation to treat ALK-positive NSCLC in patients previously treated with one or more ALK inhibitors and Orphan Drug designation to treat advanced ALK-positive NSCLC.

Pfizer is also evaluating the candidate in the Phase III CROWN trial in treatment-naïve patients with metastatic ALK-positive NSCLC.

Lorlatinib is an inhibitor of ALK and c-ros proto-oncogene 1 receptor tyrosine kinase (ROS1).