Eli Lilly has announced that the US FDA has approved Retevmo (selpercatinib) for treating metastatic RET fusion-positive NSCLC, advanced or metastatic RET-mutant MTC and advanced or metastatic RET fusion-positive thyroid cancer. The drug has been indicated for the treatment of adult patients with metastatic rearranged transfection (RET) fusion positive non-small cell lung cancer and patients aged 12 years old in patients with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) requiring systemic therapy, advanced or metastatic RET fusion-positive thyroid cancer who are radioactive iodine-refractory.
The drug is indicated only in patient suffering from
advanced or metastatic RET fusion positive NSCLC or thyroid cancer
RET mutation in MTC
The approval is based on LIBRETTO-001 Phase 1/2 trial's, primary endpoints being objective response rate (ORR) and duration of response (DoR). The study has included 702 patients.
"We are extremely proud of how quickly the combined Loxo Oncology and Lilly Oncology teams brought Retevmo to patients, further demonstrating our commitment to delivering life-changing medicines to people living with cancer," said Anne White, president of Lilly Oncology.
Retevmo is a selective kinase inhibitor and has received FDA’s accelerated approval. The drug is available in 120mg and 160mg based on weight.
The company has been conducting two confirmatory Phase 3 trials (LIBRETTO-431 and LIBRETTO-531).