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The authors of a recently published study suggested that testing metastatic breast cancer patients for kinase fusions may open up additional treatment opportunities.
The accelerated approval was granted based on data submitted from the Phase I/II LIBRETTO-001 trial.
Increasing understanding of complex tumor biology is reshaping clinical trials in the age of precision medicine, though some view these changes with concern.
The randomized, 400-patient trial will compare selpercatinib to chemotherapy for first-line treatment of medullary thyroid cancer.
The drugmaker hopes to submit this data as part of a new drug application with the FDA later this year.
AmoyDx and Premia will provide large-scale cancer patient screening in Asia to support Loxo-292 RET inhibitor clinical development.
The overlapping development programs for first-generation larotrectinib and second-generation LOXO-195 signal narrowing drug development timelines in the era of precision oncology.
In order to be eligible for the drug, patients must have NTRK fusions, which may be determined via various tests including NGS and FISH.
The companies will develop a version of Illumina's TruSight 170 sequencing panel for two of Loxo's targeted oncology drugs.
Data presented at ASCO showing 76 percent of cancer patients responded to larotrectinib could lead to the availability of the first tissue-agnostic targeted drug.