HLB's liver cancer treatment Rivoceranib closer to FDA approval

HLB Chairman Jin Yang-gon

By Lee Kyung-min

HLB, a local pharmaceutical firm, said it has received a letter of notification from the U.S. Drug Administration (FDA) for its liver cancer treatment drug Rivoceranib to undergo New Drug Application (NDA) filing acceptance, according to the firm, Tuesday.

HLB said this is the final process before FDA approval, an outcome that has been 15 years in the making, since the development of the liver cancer drug began in 2008.

The NDA, according to the FDA, is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.

“We have received the notification through our U.S. subsidiary, Elevar Therapeutics,” an HLB official said.

HLB holds global rights over the anticancer drug. It is a targeted anticancer agent targeting vascular endothelial growth factor receptor 2 by inhibiting angiogenesis growth of cancer tissues, according to the firm.

Elevar Therapeutics successfully completed Phase 3 global treatment with Rivoceranib and submitted the NDA on May 16.

The FDA is expected to announce the results of the application by May 16, 2024, at the latest.

HLB's anticancer drug has proven effective in liver cancer treatment. This is evidenced by a patient survival rate of 22.1 months, as measured by the margin of safety (MOS), the ratio of the lethal dose to 1 percent of the population to the effective dose to 99 percent of the population, which is used to measure drug safety in the pharmaceutical industry.

HLB is the first Korean anticancer drug manufacturer to undergo the NDA review.

Rivoceranib can be prescribed in all patients and no serious side effects have been reported, including bleeding or toxicity common in most anticancer drugs.

The firm said it will accelerate preparations for commercialization, as bolstered by marketing strategies and full preparation for the impending FDA due diligence.

HLB Chairman Jin Yang-gon said the firm is taking small steps.

“We will be able to achieve our goal with the spirit of passion and facing challenges head on,” he said.