The move supports the indication of a single priming anti-CTLA4 antibody dose added to the human monoclonal antibody Imfinzi (durvalumab) to treat HCC patients.
AstraZeneca also submitted a supplemental BLA (sBLA) for Imfinzi in this indication.
The FDA’s decision is expected during the fourth quarter of this year after the use of a priority review voucher.
AstraZeneca’s BLA and sBLA for tremelimumab and Imfinzi, respectively are based on final results obtained from the Phase III HIMALAYA trial.
The randomised, multicentre, open-label, global trial of Imfinzi monotherapy and the STRIDE regimen, included a total of 1,324 patients with unresectable, advanced HCC.
Subjects in the trial were treated with the STRIDE regimen and experienced a 22% reduction in the risk of death versus sorafenib.
AstraZeneca Oncology R&D executive vice-president Susan Galbraith said: “The HIMALAYA Phase III trial showed an unprecedented three-year overall survival in this setting with a single priming dose of tremelimumab added to Imfinzi, highlighting the potential for this regimen to improve longer-term survival outcomes.
“Patients with advanced liver cancer are in great need of new treatment options, and we are working closely with the FDA to bring this novel approach to patients in the US as soon as possible.”
Furthermore, the safety profiles of the STRIDE regimen and for Imfinzi alone were in line with the known profiles of each medicine in the trial. No new safety signals were reported.
In January 2020, Imfinzi and tremelimumab received Orphan Drug Designation in the US to treat HCC.