FDA Rejects Elevar, Hengrui Pharma’s Liver Cancer Combo

The FDA has declined an application from Elevar Therapeutics for the approval of their oral tyrosine kinase inhibitor rivoceranib in combination with Jiangsu Hengrui Pharmaceuticals’ PD-1 inhibitor camrelizumab for the initial treatment of patients with unresectable hepatocellular carcinoma. This decision, announced by Elevar’s parent company HLB, caused a significant drop in HLB’s stock, hitting the Korean exchange's daily limit of a 30% decrease.

Elevar's CEO, Saeho Chong, expressed his disappointment with the FDA’s decision, which came unexpectedly given the company's positive prior communications with the agency. Chong mentioned that discussions regarding the drug’s label had occurred as recently as the previous week and stated that no concerns had been raised about the clinical data.

HLB Chairman Jin Yang-gon elaborated on the FDA’s complete response letter (CRL), stating that the issues primarily concerned camrelizumab, specifically the responses from Hengrui Pharmaceuticals regarding the drug's manufacturing and quality control. Jin clarified that there were no issues related to rivoceranib and indicated that they would work with Hengrui Pharmaceuticals to address the concerns promptly.

An additional complication cited by the FDA was the inability to inspect clinical trial sites in Russia and Ukraine due to travel restrictions stemming from the ongoing conflict in the region. An Elevar representative mentioned that these inspections would be postponed until a new marketing application is submitted. Moreover, the spokesperson highlighted that the FDA will not approve rivoceranib until camrelizumab receives regulatory approval, as the safety and efficacy of rivoceranib have only been established in combination with camrelizumab.

Elevar had secured global rights, excluding China and Korea, to develop the combination of camrelizumab and rivoceranib from Hengrui Pharmaceuticals in October of the previous year. The agreement entails potential payments to Hengrui Pharma up to $600 million in sales milestones and royalties based on net sales of camrelizumab.

Jin also mentioned that he had not yet reviewed the separate CRL sent to Hengrui Pharmaceuticals by the FDA. However, he assured that Elevar intends to resubmit a new application to the FDA as soon as possible to address the issues raised and continue their efforts toward obtaining approval for the combination treatment.