FDA accepts Pfizer's Lorbrena application, action date in April 2021

 

• 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.
• https://seekingalpha.com/news/3647628-fda-accepts-pfizers-lorbrena-application-action-date-in-april-2021