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An extended labeling claim has added detection of three additional EGFR mutations to help ID NSCLC patients for whom Boehringer Ingelheim's Gilotrif is indicated.
The researchers found that most advanced EGFR-mutant lung cancer patients harbored changes in an average of two to three other oncogenes.
A Mount Sinai team performed targeted sequencing on non-small cell lung cancer samples to find mutations with clinical implications.
The changes include recommendations for first line immunotherapy in patients with high PD-L1 expression, and clarification on use of targeted therapies.
The so-called universal CDx approved by the FDA can gauge alterations across multiple genes associated with response to three lung cancer treatments.
Clinicians say they are using blood-based tests for patients who can't be biopsied as a way to get test results sooner, but implementing tests smartly and appropriately remains a challenge.
In head-to-head studies, a next-generation EGFR inhibitor and an ALK inhibitor beat their older counterparts in staving of cancer progression.
The companies believe the database can facilitate outcomes research, improve variant interpretations, inform drug development efforts.
The IHC test was used in clinical studies that led to Zykadia's approval last week as a first-line option for metastatic NSCLC patients with ALK rearrangements.
The recent failure of Bristol-Myers Squibb's lung cancer immunotherapy to meet its primary endpoint demonstrates the challenge of working with imperfect biomarkers.