Tagrisso has established itself as an EGFR treatment

Second blockbuster anti-cancer drug - Targrisso

Excellent effect of brain metastasis

Lung cancer is the No.

 

1 cancer death rate among Koreans, but treatment is greatly evolving, with the 5-year survival rate more than tripling over 20 years.

 

What had a significant impact on this was the EGFR target treatment.

 

Targeted treatments targeting EGFR mutations have dramatically improved the overall survival period of patients.

 

Among them, the third generation 'Tagrisso (Osimertinib)' has clearly established itself as a standard treatment for non-small cell lung cancer with current EGFR mutations.

 

Tagrisso is a third-generation EGFR-TKI that inhibits both EGFR variations and T790M variations represented by L858R and exon 19 deficiencies.

 

It is the only third-generation EGFR-TKI that has shown a full survival period of more than three years, which is excellent for patients with brain metastasis.

 

AstraZeneca succeeded in the first generation of Iressa and the third generation of Tagrisso.

 

Tagrisso's global sales reached $4.33 billion as of last year, becoming the first blockbuster drug in five years.

 

Ironically, Tagrisso is going through all sorts of ups and downs in Korea.

 

It's been a problem since the first registration.

 

Since its first rapid approval in the United States in November 2015, Tagrisso has been the fifth in the world to obtain an item permit in Korea.

 

At that time, Olita, the same third generation, was released in Korea.

 

Tagrisso was the only third-generation drug in the world, but competed with Olita in Korea.

 

Tagrisso was "too expensive" for the government, compared to Olita, which offered relatively low prices.

 

In November 2016, the HIRA declared Tagrisso as a non-reimbursement drug, equivalent to the economic evaluation exception scheme.

 

It passed the committee after three challenges, but negotiations with the NHIS were not easy.

 

It was first listed as a secondary treatment in December 2017.

 

Olita's development was suspended due to safety issues, and Tagrisso's quarterly sales jumped from ₩3 billion to ₩10 billion based on IQVIA.

 

However, the Asian subanalysis data of the 2019 FLAURA 3-phase study became a problem.

 

FLAURA is a global clinical trial that identifies Tagrisso's efficacy and safety as a primary treatment.

 

Overall clinical results demonstrated improvement over first-generation drugs with a total survival period of 38.6 months.

 

The problem was the result of a sub-analysis that only Asians did separately.

 

The risk ratio (HR) of the Asian subgroup is 0.995, which is virtually no difference from the control group based on 1.

 

AstraZeneca also submitted FLAURA China data for Chinese to reaffirm its effectiveness in Asians, but failed to pass the Cancer Drugs Benefit Appraisal Committee.

 

Two years have passed since the first treatment indication was added, but conditions have no longer evolved since December 2017.

 

Tagrisso's sales are steadily increasing.

 

According to IQVIA, Tagrisso's annual sales reached ₩59.4 billion in 2018 and ₩79.2 billion in 2019.

 

Last year, its annual sales surpassed ₩100 billion for the first time with ₩106.5 billion.

 

It has become a global primary standard treatment.

 

This year, Tagrisso's situation is not so good.

 

First of all, after Olita, Yuhan's Leclaza is the second competitive drug.

 

The UK, which was passive in primary care benefits due to its high cost, also recognized Tagrisso as primary standard treatment last year and applied the benefits.

 

Currently, 44 countries around the world, including the United States, Britain, Germany, France, Italy and Japan, recognize Tagrisso as a primary treatment.

 

Despite the controversy over the Asian OS, major Asian countries recognize Tagrisso as a primary treatment.

 

Tagrisso is also applied as the first benefit in major Asian countries such as Japan, China, Taiwan and Singapore.

 

After all, Tagrisso's benefit is an irresistible global trend.

 

However, as two years have passed, complaints from patients are growing.

 

It is noteworthy whether Tagrisso will be able to cross the high barrier of salary expansion amid changes in global treatment flow and demands from patients.