Under Priority Review status and its Real-Time Oncology Review and Orbis Pilot Programs, the FDA accepts Pfizer's (NYSE:PFE) supplemental New Drug Application (sNDA) for Lorbrena (lorlatinib) as a first-line treatment for people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer.

The agency's action date is April 2021.

Lorbrena is a third-generation ALK inhibitor specifically developed to inhibit the most common tumor mutations that drive resistance to current medications and to address brain metastases.