HLB's Liver Cancer Drug Listed as First-Line Treatment in ESMO Guidelines Ahead of FDA Approval

· ESMO strongly recommends rivoceranib and camrelizumab as a first-line treatment for liver cancer.

 

HLB's liver cancer drug listed as first-line treatment in ESMO guidelines ahead of FDA approval. (IT Times)

SEOUL, South Korea, February 27, 2025 (IT Times) – HLB announced that its liver cancer treatment, rivoceranib and camrelizumab, has been listed as a first-line treatment in the European Society for Medical Oncology (ESMO) Clinical Practice Guidelines for the diagnosis and treatment of hepatocellular carcinoma (HCC), with less than a month remaining until the U.S. Food and Drug Administration (FDA) announces its new drug approval decision.

The ESMO guidelines, published by its hepatocellular carcinoma division, serve as a key reference for physicians worldwide, alongside the National Comprehensive Cancer Network (NCCN) guidelines. These guidelines provide extensive information on cancer diagnosis, treatment, and follow-up care.

It is highly unusual for a drug that has not yet received regulatory approval to be recommended for prescription in medical guidelines. The guidelines also strongly recommend the prescription of rivoceranib/camrelizumab as a treatment option.

The newly revised journal, updated for the first time in three years since 2022, describes the rivoceranib/camrelizumab combination therapy as the first VEGFR-TKI and immune checkpoint inhibitor (anti-PD-1) combination to demonstrate remarkable treatment efficacy. The guidelines highlight key clinical data, including an overall survival (mOS) rate of 23.8 months, the longest recorded period to date.

Additionally, the guidelines classify the clinical evidence supporting rivoceranib/camrelizumab’s effectiveness as Level of Evidence I, the highest rating, and strongly recommend it as a first-line treatment for liver cancer patients with relatively well-preserved liver function.

Rivoceranib/camrelizumab has been listed alongside other widely used first-line treatments, including the bevacizumab/atezolizumab and durvalumab/tremelimumab combinations. However, the guidelines specify that bevacizumab-based therapies require pre-screening for patients with a history of gastrointestinal bleeding due to potential side effects. This underscores the necessity of conducting endoscopic evaluations to detect internal bleeding risks before prescribing the treatment.

Unlike Bevacizumab-based therapies, rivoceranib/camrelizumab does not pose significant gastrointestinal bleeding risks. As a result, if approved as a first-line treatment, it is expected to rapidly gain market share.

"The strong recommendation from ESMO, a globally respected authority, for rivoceranib/camrelizumab as a first-line treatment for liver cancer, signifies its recognition as an emerging international standard of care," stated Dr. Yonghae Han, Chief Technology Officer of HLB Group. "This positive endorsement provides further momentum for the ongoing regulatory review processes with the U.S. FDA and the European Medicines Agency (EMA), as well as potential inclusion in the National Comprehensive Cancer Network guidelines."

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HLB's Liver Cancer Drug Listed as First-Line Treatment in ESMO Guidelines Ahead of FDA Approval - IT타임스