FDA News

FDA grants RET inhibitor breakthrough therapy designation for lung, thyroid cancers

The FDA granted breakthrough therapy designation to LOXO-292, a selective RET inhibitor, for the treatment certain patients with RET-altered non-small cell lung cancer or medullary thyroid cancer, according to the agent’s manufacturer.

The designation includes patients with RET-fusion positive NSCLC who have progressed on platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor, and patients with RET-mutant thyroid cancer who have progressed following prior treatment and have no alternative treatment options.

The FDA based the breakthrough designation of LOXO-292 (Loxo Oncology) on the ongoing phase 1/phase 2 LIBRETTO-001 clinical trial of patients with RET-altered advanced solid tumors.

“We look forward to working with FDA to streamline the development of LOXO-292 in the two patient populations that have comprised the bulk of our initial clinical trial enrollment,” Josh Bilenker, MD, CEO of Loxo Oncology, said in a company-issued press release. “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.”

The FDA granted breakthrough therapy designation to LOXO-292, a selective RET inhibitor, for the treatment certain patients with RET-altered non-small cell lung cancer or medullary thyroid cancer, according to the agent’s manufacturer.

The designation includes patients with RET-fusion positive NSCLC who have progressed on platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor, and patients with RET-mutant thyroid cancer who have progressed following prior treatment and have no alternative treatment options.

The FDA based the breakthrough designation of LOXO-292 (Loxo Oncology) on the ongoing phase 1/phase 2 LIBRETTO-001 clinical trial of patients with RET-altered advanced solid tumors.

“We look forward to working with FDA to streamline the development of LOXO-292 in the two patient populations that have comprised the bulk of our initial clinical trial enrollment,” Josh Bilenker, MD, CEO of Loxo Oncology, said in a company-issued press release. “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.”