Impinzi's indication is expected to be approved in Korea

Food and Drug Administration's approval review is underway

Expect to improve the treatment environment

Impinzi is also expected to have options for treating immuno-cancer drugs in the area of biliary tract cancer.

 

According to related industries, the Ministry of Food and Drug Safety is reviewing the expansion of biliary tract cancer indications of Imfinzi, an immuno-cancer drug before PD-L1 inhibition mechanism.

 

Permission is possible as early as this year.

 

Impinzi is drawing more attention in Korea as researcher-led clinical trials conducted by Oh Do-yeon, a professor of oncology at Seoul National University Hospital, played a leading role in adding indications.

 

Impinzi's specific biliary tract cancer indication was validated through a TOPAZ-1 study with "conventional chemotherapy (Gemcitabine·Cisplatin, GemCis) in the primary treatment of local progressive or metastatic biliary tract cancer" and obtained approval from the U.S.

 

FDA in September.

 

The TOPAZ-1 study is a multinational, randomized, double-blind, and placebo-controlled phase 3 clinical trial in 685 patients with progressive biliary tract cancer that compared and evaluated the combination of Impinzi, which is added to the existing standard treatment "GemCis." It is also worth noting that in the TOPAZ-1 study, patient recruitment was conducted in 17 countries, including the United States, Europe, and South America, and about 55% of the total was registered in Asian countries including Korea, Thailand, Japan, and China.

 

As a result of the study, the Impinzi combined group had a 20% lower risk of death than the placebo combined group.

 

However, the extension of the median value of the total survival period was only 1.3 months compared to the control group.

 

The most commonly reported side effects were anemia (48.2%), neutropenia (31.7%), and zones (40.2%).

 

Potentially serious side effects were 62.7% in the Impinge combined group and 64.9% in the placebo combined group, suggesting that most side effects were due to chemotherapy in both groups.

 

Impinzi's expansion of biliary tract cancer indication was made under Project Orbis, priority screening, and designation of rare drugs.

 

AstraZeneca, a developer, is currently in the process of expanding its indication in many countries, including Korea, Europe, and Japan.