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The agency granted the NDA priority review, putting the application on a six-month review clock, instead of the 10-month standard review time frame.
AmoyDx aims to develop a companion diagnostic for Merck KGaA's non-small cell lung cancer treatment Tepmetko, which was recently approved in Japan.
A Sanford Cancer Center team is genomically profiling head and neck squamous cell cancer samples to look for biomarkers of immunotherapy and chemoradiation response.
The drug, tepotinib, will now be available to treat advanced non-small cell lung cancer patients in Japan with MET exon 14 skipping alterations.
The Phase I trial is hosted at two locations in Europe and will enroll up to 60 patients whose tumors overexpress the PI3K delta protein.
An IASLC survey showed that molecular testing is not performed in line with expert guidelines, which means only a minority of lung cancer patients are benefitting from precision oncology.
The German drugmaker plans to advance the NSCLC treatment in parallel with tissue-based and liquid biopsy companion assays that can identify best responders.