HLB Liver Cancer Drug Re-enters FDA Review, With Decision Due April 9
HLB’s liver cancer drug candidate has re-entered the U.S. Food and Drug Administration’s review process, bringing its bid to enter the U.S. market closer to a decision. The FDA has set April 9, 2027, as the target action date. However, the application’s Class 2 designation means the review will take
HLB's liver cancer drug candidate, rivoceranib combined with immunotherapy drug camrelizumab, has re-entered the FDA's review process, with a decision due on April 9, 2027. The combination therapy, which showed a 36% reduction in risk of death and longer median progression-free survival in a Phase 3 trial, was resubmitted following three previous Complete Response Letters.
The FDA has classified the resubmission as Class 2, which typically takes six months to review, longer than the company had hoped. The shorter-than-anticipated timeline could have led to an approval decision before the end of 2026, had the application been classified as Class 1. The news of the longer review period caused HLB shares to drop significantly on the KOSDAQ market.
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- HLB liver cancer drug enters FDA review, decision expected by April koreatimes.co.kr
