{"id":13517,"date":"2026-11-04T08:04:55","date_gmt":"2026-11-04T08:04:55","guid":{"rendered":"https:\/\/sotnews.agency\/?p=13517"},"modified":"2026-11-04T08:04:55","modified_gmt":"2026-11-04T08:04:55","slug":"hlb-liver-cancer-drug-enters-fda-review-decision-expected-by-april","status":"publish","type":"post","link":"https:\/\/sotnews.agency\/?p=13517","title":{"rendered":"HLB liver cancer drug enters FDA review, decision expected by April"},"content":{"rendered":"
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HLB corporate logo \/ Courtesy of HLB <\/p>\n<\/figcaption><\/figure>\n

Korean biopharmaceutical group HLB is getting a second shot at U.S. Food and Drug Administration (FDA) approval for its flagship liver cancer therapy. <\/p>\n

The FDA has officially accepted a resubmitted application from HLB\u2019s California-based drug development arm, Elevar Therapeutics, to evaluate a combination treatment for advanced liver cancer, setting a target decision date of April 9.<\/p>\n

Elevar said the FDA had accepted for substantive review its resubmitted new drug application for rivoceranib, an oral VEGF-targeting tyrosine kinase inhibitor, combined with camrelizumab, an anti-PD-1 antibody, as a first-line treatment for hepatocellular carcinoma.<\/p>\n

The FDA classified the application as a Class 2 resubmission, setting April 9 as its target decision date under the Prescription Drug User Fee Act.<\/p>\n

The review covers two applications submitted separately by Elevar and China’s Hengrui Pharma, which resubmitted the biologics license application for camrelizumab.<\/p>\n

The FDA plans to review the applications together to determine whether the combination therapy can be approved.<\/p>\n

The resubmissions are supported by results from the global Phase 3 CARES-310 trial, which evaluated the combination in patients with unresectable or metastatic hepatocellular carcinoma, the most common form of liver cancer.<\/p>\n

The treatment produced a median overall survival of 23.8 months, compared with 15.2 months for sorafenib, representing a statistically significant improvement, according to the company.<\/p>\n

The survival benefit was reflected in a hazard ratio of 0.64, with a 95 percent confidence interval of 0.52 to 0.79 and a P value below 0.0001.<\/p>\n

Final results from CARES-310 were published in The Lancet Oncology in December 2025.<\/p>\n

The combination was also included in 2025 treatment recommendations from the Barcelona Clinic Liver Cancer strategy and European Society for Medical Oncology guidelines for advanced hepatocellular carcinoma.<\/p>\n

“Through the CARES-310 study, we confirmed the potential of rivoceranib and camrelizumab combination therapy to meaningfully improve overall survival in first-line treatment for patients with unresectable hepatocellular carcinoma,” said Kim Dong-gun, chief executive of Elevar Therapeutics.<\/p>\n

“With the substantive review now underway, we will work closely with Hengrui Pharma to ensure thorough cooperation throughout the FDA review process.”<\/p>\n

This article was published with the assistance of generative AI and edited by The Korea Times.<\/span><\/em><\/p>\n

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HLB corporate logo \/ Courtesy of HLB Korean biopharmaceutical group HLB is getting a second shot at U.S. Food and Drug Administration (FDA) approval for its flagship liver cancer therapy. The FDA has officially accepted a resubmitted application from HLB\u2019s California-based drug development arm, Elevar Therapeutics, to evaluate a combination treatment for advanced liver cancer,…<\/p>\n","protected":false},"author":1,"featured_media":13518,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"rop_custom_images_group":[],"rop_custom_messages_group":[],"rop_publish_now":"initial","rop_publish_now_accounts":{"facebook_2277560469115098_106292521332774":"","twitter_aToxNzczMzI3Njk4OTg4ODUxMjAxOw==_1773327698988851200":""},"rop_publish_now_history":[],"rop_publish_now_status":"pending","_monsterinsights_skip_tracking":false,"_templately_pack_id":"","_templately_imported_at":"","_templately_source":"","_templately_import_session_id":"","footnotes":""},"categories":[16,14],"tags":[],"class_list":["post-13517","post","type-post","status-publish","format-standard","has-post-thumbnail","category-korea","category-trending-news"],"aioseo_notices":[],"aioseo_head":"\n\t\t\n\t\n\t\n\t\n\t\n\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t