[News Story] Leabax, the second invoicing company?... Suspicious new drug license

Liabax, which was developed as a treatment for pancreatic cancer and received conditional marketing approval in 2014.

At that time, the Ministry of Food and Drug Safety introduced this new drug as a new-concept anticancer drug, and inquiries from patients swarmed to pharmaceutical companies.

The pharmaceutical company was also selected as an innovative pharmaceutical company in two months.

However, the Ministry of Food and Drug Safety suddenly canceled the marketing permission of the item last month.

Why was the conditional permit revoked after six years?

The reporters found several questions during the approval process of the Ministry of Food and Drug Safety.

Liabaxju (GV1001), which was approved as a domestic new drug No. 21, was already a drug that was concluded as a failure in 2013.

Phase 3 clinical trials were conducted in 1,000 patients for 5 years in the UK, but efficacy was not proven.

It was confirmed that there was no significant difference in survival time in the group administered with the existing pancreatic cancer treatment and Liabax strain.

That new drug was conditionally licensed in Korea as a new drug for pancreatic cancer in just one year.

Another question is that many of the patients taking this drug, known as a treatment for pancreatic cancer, are not pancreatic cancer patients.

The medical staff of the general hospital who administered the new drug in the emergency clinical trial said that it was not used as a treatment for pancreatic cancer, but as an ``immune supplement'' that helps the treatment.

When looking at the approval process of the Ministry of Food and Drug Safety, the 29th Korean drug,'Invossakeiju', a gene therapy for osteoarthritis, is reminiscent.

It is similar in the fact that the poor verification method at the time of approval and the question about the efficacy of Invossa were buried afterwards.

The Ministry of Food and Drug Safety replied that it did not even have an examination report at the time of approval from the Liabax state.

This week, SBS <News Story> focused on the controversy and problems of the approval process about the new pancreatic cancer treatment drug'Leavaxju', whose marketing license was canceled after six years.