The U.S. Food and Drug Administration has approved a new cancer drug from Indianapolis-based Eli Lilly and Co. (NYSE: LLY). Lilly says Retevmo is the first therapy specifically used for the treatment of certain types of lung and thyroid cancers.
The company says Retevmo, or selpercatinib, was approved under the FDA’s Accelerated Approval regulations based on results of a Phase 1/2 clinical trial.
The drug, Lilly says, is used for the treatment of adult patients with metastatic rearranged during transfection fusion-positive non-small cell lung cancer, as well as the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer who require systemic therapy, or advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory.
“In the clinical trial, we observed that the majority of metastatic lung cancer patients experienced clinically meaningful responses when treated with selpercatinib, including responses in difficult-to-treat brain metastases,” said Dr. Alexander Drilon, lead investigator for the clinical trial. “The approval of selpercatinib marks an important milestone in the treatment of NSCLC, making RET-driven cancers now specifically targetable…I am pleased that patients with these RET-driven cancers have this newly approved option.”
Lilly Oncology President Anne White says the clinical trial began in May 2017 and the FDA approval represents the “most rapid timeline in the development of an oncology medicine with multiple indications.”