HLB submits fourth FDA application for liver cancer drug combination

HLB, through its U.S. subsidiary Elevar Therapeutics and partner Hengrui Pharma, has submitted a fourth application to the U.S. Food and Drug Administration (FDA) for the approval of a combination therapy for first-line liver cancer treatment. The application seeks approval for the combination of riboceranib and camrelizumab for patients with unresectable or metastatic liver cancer.

This submission follows three previous attempts that resulted in Complete Response Letters (CRL) from the FDA. The most recent setback in July was attributed to issues identified during a manufacturing facility inspection. The companies have now completed the necessary manufacturing facility inspection procedures to address these regulatory concerns.

The application is supported by data from the CARES-310 global Phase 3 clinical trial. The study demonstrated a median overall survival (mOS) of 23.8 months for the combination therapy group, compared to 15.2 months for the control group receiving sorafenib. This represents a 36% reduction in the risk of death and is noted as one of the longest survival durations reported for first-line liver cancer treatments to date. The trial results were published in ‘The Lancet Oncology’.