MFDS has completed verification of the efficacy of Retevmo

Safety and efficiency evaluation is over, prospects of item approval

The RET (Rearranged during transfection)) gene target anticancer drug developed by Lilly seems to be at the end of the domestic approval process.

 

It is a drug called Retevmo (Selpercatinib), which began licensing last year, and safety and efficiency evaluation have recently been completed and is about to be approved.

 

According to the pharmaceutical industry on the 21st, Retevmo's safety and efficiency evaluation by Lilly applied for permission, has recently ended.

 

Analysts say that the end of safety and efficiency evaluation has further increased the possibility of product approval.

 

In the case of new drugs, the MFDS will conduct GMP review to check safety, effectiveness, product quality, and compliance with manufacturing process standards through analysis of result data such as clinical trials to determine final product approval.

 

The termination of safety and efficiency evaluation, which verifies drug efficacy, is interpreted as meaning that it is almost done.

 

Retevmo is highly likely to obtain a domestic product license in that it has already received approval from the U.S.

 

FDA based on multinational clinical trials such as data on safety and efficiency evaluation by the MFDS.

 

At the time of FDA approval in May 2020, the drug was approved for use in adult patients with metastatic RET fusion-positive non-small cell cancer, medullary thyroid carcinoma over the age of 12, and Radioiodine-Refractory Thyroid Cancer.

 

The RET gene is a phosphate enzyme that can cause cancer and is known to promote the proliferation of cancer cells when mutated or combined with other genes.

 

About 2% of non-small cell carcinoma patients are found to have RET gene mutations.

 

As RET gene mutations are also found in various carcinomas, Lilly is conducting an expanded study on Retevmo's indications.

 

Retevmo was also designated as a rare drug in Korea by the MFDS in February last year.

 

In addition to Retevmo, Roche's Gavreto (Pralsetinib) targeting the RET gene is also being introduced in Korea.

 

In addition, among domestic pharmaceutical companies, HK inno.N introduced the RET target anticancer drug "VRN061782" from Voronoi in February last year and began commercialization development.