Drugs in the Pipeline Poziotinib Under Review for Previously Treated HER2 Exon 20 Insertion Mutation Positive NSCLC Publish Date February 11, 2022 A PDUFA target date of November 24, 2022 has been set for the application.
Features Indications Withdrawn as FDA Evaluates Several Accelerated Approvals Publish Date March 16, 2021 To prove clinical benefit, the FDA requires manufacturers to conduct confirmatory trials, also known as a phase 4 studies.
News Lorbrena Approved for First-Line Treatment of ALK-Positive Metastatic NSCLC Publish Date March 5, 2021 Lorbrena is a third generation ALK tyrosine kinase inhibitor.