First-ever RET inhibitor 'Retevmo' attempts reimbursement

Will swiftly conduct the necessary processes through the approval-reimbursement linkage system

Competitor ‘Gavreto’ also approved… treatment options increase in the field.

The first RET-targeted anticancer therapy is attempting to receive insurance reimbursement in Korea.

 

According to industry sources, Lilly Korea has recently submitted a reimbursement application for its ‘Retevmo (selpercatinib) that targets the RET (Rearranged during transfection)-gene fusions.

 

After receiving approval from the Ministry of Food and Drug Safety through the fast track system, the company has been making progress through the approval-reimbursement linkage system.

 

In 2020, Retevmo was approved as the first treatment option for cancer patients with RET gene alternations in the US after the FDA reviewed the drug through the Accelerated Approval and Priority Review pathway and granted the Breakthrough Therapy & Orphan Drug Designation.

 

Retevmo is indicated for the treatment of:▲ adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC); ▲adults and pediatric patients 12 years of age or older with advanced or metastatic RET-mutated medullary thyroid cancer who require systemic therapy; and ▲ adult patients who are refractory to radioactive iodine therapy and who have prior sorafenib and/or lenvatinib treatment, with advanced or metastatic RET-fusion benign thyroid cancer who require systemic therapy.

 

Retevmo is expected to compete with Roche Korea’s ‘Gavreto (pralcetinib)’ in the future.

 

Gavreto, which has the same mechanism of action as Retevmo, was approved in Korea on the 29th for the treatment of ▲ treat adult patients with RET fusion-positive locally advanced or metastatic NSCLC; and adult patients with RET-mutated locally advanced or metastatic medullary thyroid cancer that require systemic therapy.

 

Professor Byoung Chul Cho of the Yonsei Cancer Hospital’s Lung Cancer Center said, “We had no choice but to conduct chemotherapy in cancer patients with RET gene mutations due to lack of other available treatment options.

 

The approval of Retevmo will become a good alternative for patients who saw relatively low treatment effect from existing chemotherapies and had difficulties due to chemotoxicity.” Meanwhile, Retevmo demonstrated its efficacy through the LIBRETTO-001 trial that was conducted on 702 patients with advanced or metastatic solid cancer with RET mutations.

 

Patients with RET fusion-positive NSCLC, RET-mutated medullary thyroid cancer, and RET fusion-positive thyroid cancer patients with or without prior treatment experience were enrolled in the LIBRETTO-001 trial.

 

The primary endpoints of the trial were the objective response rate (ORR) and duration of response (DOR) as assessed by the independent review committee In patients with RET fusion-positive NSCLC without platinum-based treatment experience, the ORR in the Retevmo-treated group was 85%.

 

Although the median DoR was not yet reached, 79% of the patients showed duration of response during the follow-up period (median 7.4 months).

 

In patients with platinum-based treatment experience, the ORR was 64%, and the median DoR was 17.5 months.