Eli Lilly: Olomorasib receives Breakthrough Therapy designation from FDA

 Eli Lilly has won a key U.S. Food and Drug Administration designation for its investigational drug olomorasib in certain lung cancer patients.

Eli Lilly on Thursday said the FDA granted breakthrough-therapy designation to olomorasib, in combination with Merck's blockbuster cancer drug Keytruda, for the first-line treatment of patients with unresectable advanced or metastatic non-small cell lung cancer with a KRAS G12C mutation.

The FDA's breakthrough-therapy designation aims to expedite the development and review of a drug for serious conditions when preliminary clinical evidence shows the drug might offer substantial improvement over available therapies.

Eli Lilly said the FDA's designation for olomorasib is based on encouraging results from a Phase 1/2 study and the dose-optimization portion of a Phase 3 trial.

The Indianapolis drugmaker said the designation recognizes the potential for olomorasib to be a meaningful treatment advance and highlights the continued unmet need for improved options for patients with KRAS G12C-mutant NSCLC non-small cell lung cancer.

https://www.morningstar.com/news/dow-jones/202509043391/eli-lilly-gets-fda-breakthrough-designation-for-olomorasib-in-lung-cancer