May 8, 2020 – The U.S. FDA has approved RetevmoTM (selpercatinib), manufactured by Eli Lilly, to treat certain patients who have lung or thyroid cancer and RET gene alterations. It is the first therapy to receive FDA approval to treat cancers that have an associated RET gene alteration.

Retevmo is indicated to treat:

Adult patients who have metastatic RET fusion-positive non-small cell lung cancer (NSCLC);
Adult and pediatric patients 12 years of age and older who have advanced or metastatic RET-mutant medullary thyroid cancer (MTC) and require systemic therapy; and
Adult and pediatric patients 12 years of age and older who have advanced or metastatic RET fusion-positive thyroid cancer, require systemic therapy, and are radioactive iodine-refractory (if radioactive iodine is appropriate).

Up to half of all RET fusion-positive NSLC will metastasize into the brain, while RET gene alterations occur in the majority of medullary thyroid cancers and a significant portion of other types of thyroid cancer. Retevmo targets RET alterations and blocks an enzyme that cancer cells need to maintain their growth.

In a clinical trial, Retevmo delivered up to an 84% overall response rate (ORR) in patients diagnosed with RET-fusion positive NSCLC. Patients diagnosed with advanced or metastatic RET-mutant MTC had up to a 73% ORR, while patients with RET fusion-positive thyroid cancer had an ORR of up to 100%. The ORR was lower across all three diagnoses for patients who had received previous treatment for their cancer than patients who were treatment naïve. For all three diagnoses, at least half of patients who responded to treatment experienced a duration of response lasting six months or more.

Recommended dosing with Retevmo is based on weight. Patients who weigh less than 50kg (110 pounds) should take 120mg by mouth twice daily, while patients who weigh 50kg or more should take 160mg by mouth twice a day. Retevmo requires dosage adjustment in patients who have severe hepatic impairment. Eli Lilly has launched the drug at a wholesale acquisition cost (WAC) of $20,600 for a one-month supply at the 160mg daily dosing.