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.
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.
