Posted by Michael Wonder on 29 Dec 2020
Lorbrena (lorlatinib) supplementary new drug application in previously untreated ALK positive lung cancer accepted for priority review by U.S. FDA
28 December 2020 - Supplemental new drug application being reviewed under FDA Real-Time Oncology Review and Project ORBIS pilot programs.
Pfizer today announced that the U.S. FDA has accepted for priority review the supplemental new drug application for Lorbrena (lorlatinib) as a first-line treatment for people with anaplastic lymphoma kinase positive metastatic non-small cell lung cancer.
The application is based on data from the pivotal CROWN trial and is being reviewed by the FDA under its Real-Time Oncology Review (RTOR) pilot program.
