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US FDA clears Loxo Oncology's application for cancer drug

The U.S. FDA cleared Loxo Oncology Inc.'s investigational new drug application for its next-generation tyrosine receptor kinase, or TRK, inhibitor, LOXO-195, to treat patients with TRK fusion cancers who become resistant while receiving another TRK inhibitor, such as larotrectinib.

Loxo plans to develop the product as a sequential treatment, to follow larotrectinib or another TRK inhibitor, to extend the total time of benefit from TRK inhibition.

The drug will initially be studied in a phase 1/2 trial, whose primary objective will be to determine the maximum tolerated dose or recommended dose for further study.