Is the KRAS gene-targeted drug also released in Korea?

The MFDS has completed Amgen Lumakras' safety and effectiveness screening

There is a possibility of approval soon

The first KRAS gene-targeted anticancer drug approved by the U.S.

 

Food and Drug Administration (FDA) in May last year is expected to be approved soon in Korea.

 

It is Amgen's Lumakras (Sotorasib), which is expected to provide new treatment opportunities to KRAS mutant patients in about 5% to 8% of non-small cell lung cancer patients in Korea.

 

According to the pharmaceutical industry on the 5th, the MFDS recently ended the safety and effectiveness screening of Lumakras.

 

Analysts say that as the safety and effectiveness screening has ended, there is a high possibility of obtaining permission soon if there are no other variables.

 

The drug drew attention when it was approved by the FDA in May last year.

 

This is because it was the first KRAS gene-targeted anticancer drug.

 

Lumakras demonstrated the efficacy of ORR at 36% in a clinical trial (CodeBreaK 100) in 124 patients with KRAS G12C mutation-positive non-small cell lung cancer.

 

The median reaction duration was 10 months.

 

The KRAS gene was the first mutant gene discovered in lung cancer in 1982, but unlike the EGFR and ALK genes, no targeted treatment was available.

 

The KRAS gene itself has many types of mutations and is due to its structural characteristics that are difficult to develop target substances.

 

Lumakras also targets the G12C gene among KRAS gene mutations.

 

In Korea, it is known that KRAS mutation patients account for about 5-8% of all non-small cell lung cancer patients.

 

The patients have been using Taxane therapy because they do not have other targeted treatments, and it is said that immuno-cancer drugs are also being used recently.

 

Amgen reportedly applied for permission to the MFDS immediately after Lumakras received FDA approval.

 

Currently, not only Amgen but also several pharmaceutical companies are focusing on developing new drugs for KRAS mutation.

 

Seven pharmaceutical companies entered clinical trials related to KRAS last year.

 

These include multinational pharmaceutical companies such as Novartis, Roche, Beringer Ingelheim, MSD, and Lilly.

 

Clinical research is also underway to see if Lumakras can be applied not only to non-small cell lung cancer but also to direct bowel cancer.

 

This is because 3-5% of patients with direct bowel cancer are caused by KRAS mutations.