[Reporter's view] Only 2% of patients

Will speed of rare cancer registration be improved?

#Will the new EGFR Exon 20 Insertion-Mutated Non-Small-Cell Lung Cancer treatment, which was useless for existing TKI, be able to receive insurance benefits?

 

It's all the same cancer, but it's different.

 

Cancer species such as liver cancer, stomach cancer, and lung cancer, which we call, are only a simple category, and in fact, they are classified in detail.

 

Even if tumors originate from the same organ, the difficulty of treatment varies according to this detailed classification and the number of patients also varies.

 

For example, EGFR Exon 20 Insertion-Mutated Non-Small-Cell Lung Cancer is so rare that only 2% of EGFR mutated non-small cell lung cancer patients in Korea are identified.

 

Until now, there has been no suitable treatment for the treatment of this disease, and the NCCN guidelines have also recommended platinum-based anticancer therapy.

 

Even this is subject to reduction in Korea.

 

Lung cancer is not a rare disease, but EGFR Exon 20 Insertion–Mutated Non–Small-Cell Lung Cancer can be a rare cancer.

 

EGFR Exon 20 Insertion–Mutated Non–Small-Cell Lung Cancer has a 75% higher risk of death compared to common EGFR mutated non-small cell lung cancer, a 5-year survival rate of 8% and patient life expectancy of less than 2 years.

 

In this situation, the anticancer drug Rybrevant, which targets EGFR Exon 20 Insertion-Mutation, will be submitted to the HIRA Cancer Disease Review Committee on the 29th to register insurance benefits.

 

This drug, well known as Leclaza's combination therapy partner, was approved in Korea in February this year as the first targeted treatment for EGFR Exon 20 Insertion-Mutated Non-Small-Cell Lung Cancer treatment.

 

Rybrevant confirmed the overall response rate (ORR) of 40% through a CHRYSALIS clinical study, with 4% of patients achieving CR and 36% achieving PR.

 

In recognition of its value as a treatment for rare carcinomas, it was quickly approved by the U.S.

 

FDA in May last year with only the results of phase 1 clinical trials, and was designated as a subject for rapid review in Korea before obtaining permission.

 

The question is whether or not value is recognized in the benefit evaluation.

 

As it is a drug licensed as a single-Arm clinical data without a control group, the key is whether the value of Rybrevant, which should take the PE system, can be recognized as rare cancer, not just lung cancer.

 

The new government, which was launched last month, promised to promote a rapid registration system for anticancer drugs and treatments for severe rare diseases without alternative drugs.

 

It remains to be seen whether the speed of registration of rare disease and rare cancer drugs in Korea can be improved in the future.