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Loxo Oncology, Inc, a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to LOXO-101, a selective inhibitor of tropomyosin receptor kinase (TRK), “for the treatment of unresectable or metastatic solid tumors with NTRK-fusion proteins in adult and pediatric patients who require systemic therapy and who have either progressed following prior treatment or who have no acceptable alternative treatments.”
“We’re pleased to have been granted Breakthrough Therapy Designation for LOXO-101 and look forward to working more closely with the FDA to bring this therapy to patients with TRK fusion cancers,” said Josh Bilenker, M.D., chief executive officer at Loxo Oncology. “Data presented to date from the ongoing adult and pediatric studies of LOXO-101 have demonstrated durable anti-tumor activity across TRK fusion cancers, further validating LOXO-101’s potential to address the unmet medical need among patients with these genetically defined cancers. We remain on track to provide an enrollment update regarding the LOXO-101 Phase 2 trial in the second half of 2016.”
The LOXO-101 Breakthrough Therapy Designation application included data from the ongoing Phase 1 dose-escalation study of LOXO-101 in adult patients with advanced solid tumors, the ongoing Phase 1 pediatric study of LOXO-101 in patients with advanced solid tumors or primary CNS tumors, and the ongoing Phase 2 basket trial of LOXO-101 in adult cancer patients whose tumors harbor TRK fusions.
