Retevmo FDA approval : Eli Lilly and Company (Lilly) has secured approval from the US Food and Drug Administration (FDA) for Retevmo (selpercatinib, 40mg and 80mg capsules) for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC).
Retevmo has also been approved by the FDA for the treatment of both adult and pediatric patients, aged 12 years and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who need systemic therapy, or advanced or metastatic RET fusion-positive thyroid cancer who need systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is not suitable).
Previously known as LOXO-292, Retevmo is a selective RET kinase inhibitor, which has been approved under the FDA’s Accelerated Approval regulations. The accelerated approval has been granted based on the endpoints of the objective response rate (ORR) and duration of response (DoR) of the LIBRETTO-001 phase 1/2 trial.
Continued approval for the indications could be subject to verification and description of clinical benefit in confirmatory trials.
Commenting on Retevmo FDA approval, Alexander Drilon from the Memorial Sloan Kettering Cancer Center, who was the lead investigator for the LIBRETTO-001 phase trial, said: “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.
“The approval of selpercatinib marks an important milestone in the treatment of NSCLC, making RET-driven cancers now specifically targetable in the same manner as cancers with activating EGFR and ALK alterations, across all lines of therapy. I am pleased that patients with these RET-driven cancers have this newly approved option.”
Lilly gained rights to the RET inhibitor after the acquisition of Loxo Oncology, a Connecticut-based biopharma company, in February 2019. (Read : Lilly acquisition of Loxo Oncology)
Anne White – president of Lilly Oncology, commenting on Retevmo FDA approval, said: “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.
“Retevmo entered clinical trials in May of 2017 and is now approved less than three years later, representing the most rapid timeline in the development of an oncology medicine with multiple indications. We applaud the FDA for their leadership and collaboration, recognizing the importance of bringing a new therapy to patients with advanced or metastatic RET-driven lung and thyroid cancers.”