News
FDA Approves Blood-Based Test as Companion Diagnostic for Multiple Cancer Drugs
Using a blood sample, the test is able to analyze more than 300 cancer-associated genes for alterations.
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Drugs in the Pipeline
Poziotinib Under Review for Previously Treated HER2 Exon 20 Insertion Mutation Positive NSCLC
A PDUFA target date of November 24, 2022 has been set for the application.
Features
Indications Withdrawn as FDA Evaluates Several Accelerated Approvals
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
Lorbrena is a third generation ALK tyrosine kinase inhibitor.
