FDA formally accepts resubmission, initiates 6-month review with a target date of April 9, 2027
Following cholangiocarcinoma approval, market eyes subsequent milestone; global Phase 3 shows 23.8-month overall survival
HLB (028300), which secured its first oncology drug approval in the US last September, has entered the formal US Food and Drug Administration (FDA) review process for its liver cancer treatment. The FDA has classified the resubmission of the combination therapy of rivoceraninib and camrelizumab as a Class 2 review, setting a Prescription Drug User Fee Act (PDUFA) target action date of April 9, 2027. Consequently, approval within this calendar year is no longer expected, putting the combination therapy back under regulatory scrutiny after global Phase 3 trials demonstrated an 8.6-month extension in overall survival compared to existing therapies.
HLB announced on the 4th that its US subsidiary, Elevar Therapeutics, received notification from the FDA that the New Drug Application (NDA) for the rivoceraninib and camrelizumab combination therapy as a first-line treatment for hepatocellular carcinoma has been accepted for formal review.
FDA resubmission reviews are typically categorized into Class 1, which takes roughly two months, and Class 2, which takes six months, depending on the scope of the resubmission. The current application has been classified as Class 2, with the PDUFA target review date set for April 9, 2027. This target date represents the FDA's goal for completing the review and does not guarantee final approval.
Elevar resubmitted the NDA for rivoceraninib on October 9. China’s Hengrui Pharma also resubmitted the Biologics License Application (BLA) for the combination partner, camrelizumab. The FDA will review the approval of both drugs concurrently.
Expanding US Oncology Business from Cholangiocarcinoma to Liver Cancer
On September 23 (local time), HLB secured FDA approval for Repictu (generic name: lirafugratinib). Repictu is indicated for previously treated adult patients with locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene fusions or rearrangements.
Elevar holds the global exclusive commercialization license for Repictu and has been preparing for its US launch. Securing approval for the liver cancer treatment would allow the company to supply two distinct oncology drugs targeting different cancer types to the US market. Furthermore, the FDA regulatory experience and local business infrastructure accumulated during the Repictu approval process can be leveraged for the commercialization of subsequent pipeline drugs.
Rivoceraninib is an oral targeted anti-cancer drug that inhibits tumor angiogenesis, while camrelizumab is an immune checkpoint inhibitor targeting the PD-1 protein. The combination therapy was approved in China in 2023 as a first-line treatment for unresectable or metastatic hepatocellular carcinoma. Elevar holds commercialization rights for the combination therapy in regions outside of China and South Korea.
The 23.8-month overall survival is among the longest reported in major global Phase 3 trials for first-line liver cancer treatments. It is comparable to the 23.7 months recorded by Bristol Myers Squibb’s (BMS) Opdivo-Yervoy combination therapy in the CheckMate-9DW trial. Because these figures stem from separate clinical trials, they do not imply a direct head-to-head superiority between the treatments.
The final results of the CARES-310 study were published in December 2025 in the international medical journal *The Lancet Oncology*. The combination therapy has also been included as a first-line treatment option for advanced hepatocellular carcinoma in the Barcelona Clinic Liver Cancer (BCLC) and European Society for Medical Oncology (ESMO) guidelines.
HLB proceeded with the resubmission process by addressing the manufacturing and quality control deficiencies raised during the previous FDA review. The current formal review will evaluate the supplementary data and compliance with manufacturing and quality standards.
Kim Dong-gun, CEO of Elevar Therapeutics, stated, “Through the CARES-310 study, we demonstrated the potential for meaningful improvements in overall survival in first-line treatment for patients with unresectable hepatocellular carcinoma using the rivoceraninib and camrelizumab combination. Now that the formal review has resumed, we will work closely with Hengrui Pharma to ensure a rigorous and thorough FDA review process.”
