Posted by Michael Wonder on 04 Mar 2021
U.S. FDA expands approval of Pfizer's Lorbrena as first-line treatment for ALK positive metastatic lung cancer
3 March 2021 - Approval is based on CROWN trial, which showed a 72% reduction in risk of progression or death for treatment with Lorbrena vs. Xalkori.
The U.S. FDA approved Pfizer's supplemental new drug application for Lorbrena (lorlatinib), expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).
Lorbrena is now indicated for adults with metastatic NSCLC whose tumours are ALK-positive as detected by an FDA approved test. The FDA action also converts the 2018 accelerated approval to full approval.
The application was approved under the FDA’s Real-Time Oncology Review pilot program.
