Loxo Oncology to Seek FDA Approval for Pan-Cancer Drug in Patients with TRK Fusions

CHICAGO – Loxo Oncology will seek US Food and Drug Administration approval for larotrectinib as a treatment for patients with TRK fusion-positive tumors after three-quarters of participants in a combined analysis responded to the drug.

The data presented at the American Society of Clinical Oncology, with additional follow up and blinded confirmation via central radiology review, will support a new drug application to the FDA for larotrectinib, Loxo Oncology CEO Joshua Bilenker said. If approved, larotrectinib will be another option for patients whose specific genomic characteristics will determine whether he or she receives the drug, regardless of where in their bodies the tumors occur.

At the meeting, David Hyman from Memorial Sloan Kettering Cancer Center discussed combined analysis from a Phase I, Phase I/II, and Phase II study involving a total of 55 adult and pediatric patients with TRK fusions across 17 unique cancer types, and showed that 76 percent responded to the therapy. In those studies 12 percent saw their tumors entirely disappear while 64 percent saw theirs tumors partially shrink.

Two patients with complete responses were able to have surgery that may be potentially curative, Hyman highlighted. More than 90 percent of responding patients remained on therapy as

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