Connecticut biotech Loxo Oncology is hoping to upend decades of Food and Drug Administration dogma with its cancer drug, seeking what would be a pioneering approval to treat a wide array of tumors with one pill. And, judging from an early peek at Loxo’s clinical data, experts say the plan just might work.
Loxo’s drug, larotrectinib, is designed to kill off tumors by attacking a protein called TRK, which becomes hyperactive in people with certain genetic mutations. But where most drugs are studied in one cancer type at a time, Loxo aims to market its therapy for any tumor that expresses the TRK protein, and it’s building up evidence to convince the FDA.
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Ignyta’s product Entrectinib is having good results, works on a variety of tumors that have TRK and other mutations AND passes the blood brain barrier. Disclosure I have a family member in a trial and she has had amazing results and we are very grateful. Your mileage may vary.
Isn’t this what just got approved with Merck’s Keytruda (pembrolizumab), based on PD-L1 expression biomarker, not tumor location? Loxo isn’t breaking any new barriers.