Loxo Oncology announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to LOXO-292 for the treatment of patients with metastatic RET-fusion-positive non-small cell lung cancer who require systemic therapy and have progressed following platinum-based chemotherapy and an anti-PD-1 or anti-PD-L1 therapy, and for the treatment of patients with RET-mutant medullary thyroid cancer who require systemic therapy, have progressed following prior treatment and have no acceptable alternative treatment options. 

LOXO-292, a selective RET inhibitor, is intended to treat patients with cancers that have abnormalities in the rearranged during transfection (RET) kinase. It is being evaluated in the ongoing Phase 1/2 LIBRETTO-001 clinical trial. The open-label, first-in-human study was designed to evaluate the safety, pharmacokinetics, tolerability, and preliminary anti-tumor activity in patients with advanced solid tumors, including RET-fusion-positive solid tumors, medullary thyroid cancer and other tumors with RET activation.

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“Given the many available therapies for non-small cell lung cancer and medullary thyroid cancer, we are pleased that LOXO-292 has shown encouraging data in refractory patients, and hope to demonstrate the full potential of this treatment in additional populations over time,” said Josh Bilenker, MD, chief executive officer at Loxo Oncology.

For more information visit LoxoOncology.com.