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News and reporting on ROS1 biomarkers.
This is the third drug the agency has approved with a pan-cancer indication.
The study plans to recruit close to 300 patients with advanced non-small cell lung cancer, with half being treated based on liquid biopsy results.
Regulators in the country granted additional approval of the test as a companion diagnostic for Rozlytrek, marketed in Japan by Roche's Chugai Pharmaceutical.
Researchers are collecting genomic and clinical data on cancer patients outside of clinical trials to understand tumor biology, treatment efficacy, and care gaps.
In the Phase I/IB study, only patients with NTRK or ROS1 fusions, or an ALK fusion or mutation responded to entrectinib, while patients without these tumor markers didn’t respond.
News on molecular markers used to guide cancer treatment, assess prognosis, or detect relapse.
In the JAMA study, researchers confirmed the previously known clinical and genomic features of NSCLC patients in their large clinico-genomics database.
The draft guidelines have intrigued industry players interested in pursuing labeling that would allow their CDx to direct treatment for a class of drugs instead of one drug.
The new guidelines said ROS1, KRAS, BRAF, MET, RET, and HER2 should be included in targeted and expanded panels.
Next year, the company will submit regulatory filings for the drug in two molecularly defined indications and a next-generation sequencing companion diagnostic.