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Pancreatic cancer is classified as a cancer that is difficult to treat. In 2014, a Korean pharmaceutical company received marketing approval from the Ministry of Food and Drug Safety, saying that it developed a new drug to treat pancreatic cancer.

Although the patients and their families had high expectations, this drug was canceled last month. As we reported, the approval process for the new drug was not confirmed in the first place, and there were consistent problems after that, but it was confirmed that it was ignored.

There are many similarities to the Invossa Incident that caused ripples last year.



Reporter Jung Myung-won reports exclusively.



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new drug for treating pancreatic cancer, which was approved by the Ministry of Food and Drug Safety in 2014 for conditional marketing and phase 3 clinical trials, saying it is a new concept anticancer drug.



The reason was to expand treatment opportunities for patients with pancreatic cancer with high levels of iotaxin, an immune substance in the blood.



However, at a general hospital that prescribed Liabax for the past six years, more than 90% of them were administered as an adjuvant to cancer patients other than pancreatic cancer.



What is the reason?



[Professor Jong-kwon Choi / Department of Hematology and Oncology, Konyang University Hospital: This is not an anticancer drug.

Go in and have nothing to do with cancer cells.

How do you know if that chunk of meat is now cancer or not?

It fits your skin too...

.]



As a result of an interim analysis last year, it was concluded that the drug was not effective, and the Central Pharmacist Review Committee was also held.



Some committee members pointed out, "Why should doctors use this drug in combination with a pancreatic cancer drug that doctors do not use much, even though there is a better treatment?"



However, the Ministry of Food and Drug Safety only stopped administering new patients and maintained the phase 3 clinical trial and approval.



[Lee Dong-geun / Secretary General of the Pharmacopoeia for a Healthy Society: In order to use this Liavax, we have to use a little less therapeutic agent.

At the same time, you can think of it as such a case that deprives pancreatic cancer patients of adequate treatment opportunities.]



Liabax is a drug that was concluded as a failure in phase 3 clinical trials involving 1,62 people in the UK in 2013, a year before domestic approval. .



As a result of analyzing the blood after obtaining additional consent of 79 patients after clinical failure, the level of iotaxin, an immune substance, was high in 16 patients with longer survival periods, and Liabax applied for approval in Korea, saying that it would be effective for them. .



After clinical failure, the Ministry of Food and Drug Safety reported the findings through retrospective analysis as a new phase 2 clinical result and even gave a conditional marketing authorization.



[Professor Park In-geun/Gachon University Gil Medical Center Hematology Oncology: Analyzing the retrospective data of the Phase 3 study and calling it (New Clinical) Phase 2 is actually ridiculous.

Phase 2 research is actually phase 3 and the goal is different.] In the



first approval review report of the Ministry of Food and Drug Safety, it was confirmed that there was a question about the effectiveness of the eotaxin test.



A poster by a British researcher also concluded that additional clinical trials were needed as the causal relationship between pancreatic cancer and eotaxin was unknown.



It wasn't even that the level of Iotaxin went up in the wake of Liabax.



The iotaxin test, an immune substance in the blood, was not approved as a diagnostic test, and a problem was raised inside the Ministry of Food and Drug Safety last year.



[Kang Yun-hee/Dept. of Diagnostic Laboratory Medicine (Former KFDA clinical review committee): Based on the results of this test, the permission was granted.

Then, patients are in a situation where they are required to receive drugs based on the results of tests that have not been approved.]



Gembax had no production facilities, so it acquired Samsung Pharmaceuticals four months before the approval, and the KFDA first gave permission and then The production facility has been certified.



This is the only case among new domestic drugs.



[Soo-Jung Lee/Director of Drug Quality, Ministry of Food and Drug Safety: At that time, when we approved this drug, we considered it suitable for the approval when we reviewed all such circumstances.]



GemVax innovates two months after obtaining conditional approval. It was also selected as a pharmaceutical company.



It became the target of 100 billion won in research funding and tax benefits.



While suspicion about the permitting process is growing, the Ministry of Food and Drug Safety said it did not even have a final permit review report.



(Video coverage: Lee Won-sik)