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Roche's real-time PCR test detects defined mutations of the epidermal growth factor receptor gene in DNA from non-small cell lung cancer patients.
The agency approved the test for use across solid tumors and with multiple companion diagnostic indications including one for prostate cancer and three for lung cancer.
However, the lack of biomarker-specific treatment data kept researchers from definitively concluding that precision oncology treatments were behind an accelerated rate of NSCLC mortality decline.
The agency based its decision on a trial showing that patients receiving the combo had a median PFS of 19.4 months versus 12.4 months for those on Tarceva.
Results from the CheckMate-227 trial provided evidence for the use of nivolumab and ipilimumab in combination, while the FLAURA study focused on osimertinib.
Progression-free survival times were comparable for EGFR-mutated non-small cell lung cancer cases treated with a combination of erlotinib and bevacizumab treatment or erlotinib.
Labs in China can now use the Cobas EGFR Mutation Test v2 with either tissue or plasma samples as a CDx for three Roche oncology drugs in NSCLC patients.
Instead of trying to tackle resistance by targeting rare mutations, researchers are looking to antibody based therapies that are more broadly active in lung cancer patients.
New tumor profiling papers stemming from prior clinical trials led to informative mutations in early-stage, ER+/HER2- breast cancer and lung squamous cell carcinoma.