Lilly’s Retevmo® (selpercatinib, 40 mg & 80 mg capsules) is approved by the U.S. Food and Drug Administration (FDA) as the first therapy for patients with specific lung cancer and the treatment of patients with specific thyroid cancers.
According to Lilly, the drug is specifically for patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), and the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET mutant medullary thyroid cancer (MTC) who require systemic therapy, or advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
Retevmo marks an important milestone as a newly approved selective RET kinase inhibitor that works by targeting RET-driven cancers.
Retevmo received Accelerated Approval by the FDA based on the LIBRETTO-001 Phase 1/2 trial’s endpoints of overall response rate (ORR) and duration of response (DoR). LIBRETTO-001 Phase 1/2 is the largest trial ever reported in patients with RET-driven cancers.
The clinical trial showed meaningful responses to the majority of metastatis lung cancer patients, including difficult-to-treat brain metastases.
Lilly said continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials. Further details about this important treatment option can be found on Lilly’s website here.