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The pandemic has underscored the importance of "bringing the trial to the patient," a concept that is likely to persist, particularly in precision oncology.
Thermo Fisher said the assay is the first and, so far, only FDA-approved test of its kind for a targeted treatment for RET fusion-positive NSCLC.
The agency approved the drug for metastatic, RET fusion-positive, non-small cell lung cancer patients who are identified by an FDA-approved test.
The collaboration will allow the companies to expand pralsetinib to multiple cancer indications and explore codevelopment of a next-generation RET inhibitor.
The Cambridge, Massachusetts-based company recently reported positive interim results for the RET-targeting agent from the Phase I/II ARROW study.
At ASCO, Blueprint presented positive data on its RET inhibitor pralsetinib across a range of cancers and in a call with investors discussed regulatory plans in lung and thyroid cancers.
The accelerated approval was granted based on data submitted from the Phase I/II LIBRETTO-001 trial.
The company announced that it is planning to submit an NDA for the drug in RET-mutant medullary thyroid cancer.
Increasing understanding of complex tumor biology is reshaping clinical trials in the age of precision medicine, though some view these changes with concern.
The company will submit the data as part of a new drug application for pralsetinib for RET fusion-positive non-small cell lung cancer.