5 September 2018 - Loxo Oncology today announced that the U.S. FDA has granted breakthrough therapy designation to LOXO-292, a selective RET inhibitor, 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.
  

The LOXO-292 breakthrough therapy designation was based on data from the ongoing global Phase 1/2 LIBRETTO-001 clinical trial. In 2019, the company plans to provide an update on the overall long-term LOXO-292 clinical development plan, based on feedback from global regulators.

Read Loxo Oncology press release