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A secondary analysis suggested that using NGS to identify patients with PTEN loss may be better than IHC in identifying best responders to treatment.
The test detects the presence of two biomarkers within a single cell associated with HPV infections that can progress to cervical cancer.
Two studies, one positive and one negative, give proponents and skeptics more data to parse in debating whether genomically guided treatment has broad value in lung cancer.
Entrectinib is authorized for advanced NTRK fusion-positive solid tumors with no alternative treatment, and ROS1-positive NSCLC patients.
The approval is based on the results from the Phase III IMspire150 study, in which patients treated with the three-drug combination had an improvement in progression-free survival.
The test detects the HER2 biomarker in breast cancer and can be completed within the same day, allowing for faster results than other HER2 testing methods.
Over the last six months the agency approved 21 cancer treatments for molecularly defined indications compared to 12 during the same period last year and 20 during all of 2019.
The collaboration will allow the companies to expand pralsetinib to multiple cancer indications and explore codevelopment of a next-generation RET inhibitor.
Thermo Fisher has also applied to the Japanese Ministry of Health, Labor, and Welfare to expand the use of the Oncomine Dx Target test in Japan.
The committee recommended the tumor-agnostic drug for use in the Cancer Drugs Fund while awaiting mature survival data from ongoing clinical trials.