FDA Review Timeline Set for HLB’s Liver Cancer Drug, Raising Hopes for Commercialization of Two Anticancer Drugs

[Financial News] HLB’s liver cancer drug is once again drawing attention after the schedule for its FDA approval review was finalized. Interest is growing in whether HLB, which received FDA approval this year for its biliary tract cancer treatment LYRFIGTU, can also secure approval for its liver cancer drug and become the first company in Korea to hold two FDA-approved anticancer drugs.
According to HLB on the 4th, its U.S. subsidiary Elevar Therapeutics was notified by the FDA that the resubmitted application for approval of the rivoceranib-camrelizumab combination as a first-line treatment for liver cancer had been classified as Class 2. Accordingly, the FDA review period was set at six months, with a target action date of April 9 next year. Elevar had previously resubmitted the application for approval of the combination therapy on the 9th of last October (all dates and times hereafter are local).
HLB received FDA approval on the 23rd of last September for its biliary tract cancer treatment LYRFIGTU (ingredient: futibatinib). If its liver cancer drug is also approved, the company will have two FDA-approved anticancer drugs targeting different cancer types: biliary tract cancer and liver cancer.
Expectations for the liver cancer drug are based on treatment benefits demonstrated in the global Phase 3 trial (CARES-310). The rivoceranib-camrelizumab combination achieved a median overall survival (mOS) of 23.8 months, significantly extending survival compared with 15.2 months for the control group treated with sorafenib. It also showed a statistically significant improvement in progression-free survival (PFS), demonstrating its potential as a first-line treatment for liver cancer.
Measures have also been taken to address issues raised during the approval process. The manufacturing and quality control (CMC) issues with camrelizumab flagged in an earlier review were not raised again in a subsequent Complete Response Letter (CRL), while matters related to the rivoceranib manufacturing facility were closed with a Voluntary Action Indicated (VAI) classification following an FDA inspection. Notably, no separate requests for additional information about the combination therapy’s clinical efficacy or safety have been made in the reviews conducted to date.
Another reason the liver cancer drug’s potential approval is drawing attention is the business synergy it could bring with LYRFIGTU, which has already received FDA approval. Last September, Elevar secured FDA approval for LYRFIGTU for patients with cholangiocarcinoma involving FGFR2 fusions or rearrangements, and is pursuing entry into the U.S. market through a direct sales system.
Because treatments for cholangiocarcinoma and liver cancer are primarily prescribed by the same specialists in gastrointestinal cancers, the company is expected to be able to leverage the U.S. sales network built for LYRFIGTU if the liver cancer drug is also approved. Expanding the market for both anticancer drugs while reducing the burden of building a separate sales organization is expected to further improve sales efficiency and business competitiveness.
The ability to use the sales and marketing infrastructure built for LYRFIGTU’s U.S. launch is also expected to benefit the liver cancer drug’s initial market entry. If commercialization of both anticancer drugs gains momentum, Elevar’s revenue base is expected to expand, while its position as a global company specializing in anticancer drugs is also expected to strengthen.
An HLB Group representative said, “With FDA approval of LYRFIGTU, we secured our first achievement in developing innovative anticancer drugs for global markets and entering the U.S. market.” The representative added, “If the liver cancer drug is also approved, we will be able to commercialize two anticancer drugs directly in different therapeutic areas, and we will continue to strengthen our competitiveness by leveraging our business foundation in the United States.”
[email protected] Choi Doo-seon Reporter