The approval is based on results of the PROfound trial, which included men with mutations in BRCA1/2 or ATM, and 12 other genes associated with the HRR pathway.
The prospective study will combine real-world, clinical, and genomic data to streamline lung cancer clinical trials and find treatment-response biomarkers.
The oral MET inhibitor, marketed as Tabrecta, is for patients whose tumors have a mutation that leads to MET exon 14 skipping as detected by a Foundation Medicine test.
The FDA approved the drug based on data on response rate but continued approval is contingent on the results of a randomized study showing a PFS and OS advantage.
A new analysis suggests hypermutation can occur in some chemotherapy-treated gliomas, producing heterogeneous, mutation-rich tumors with poor response to anti-PD-1 treatment.
With TMB as a CDx, the drug will be available to more patients as a salvage option, but doctors will still need to consider the complex biomarker amid evolving research.
Foundation Medicine's liquid biopsy test will be used in the third stage of SCRUM-Japan, which focuses on advanced cancer patientsin Japan and other Asian countries.
Florida Politics reports Florida's law barring life, long-term care, and disability insurers from using genetic information in coverage decisions went into effect at the beginning of July.
