The US Food and Drug Administration (FDA) has granted priority review to AstraZeneca's supplemental biologics licence application (sBLA) for Imfinzi (durvalumab), a human monoclonal antibody, for muscle-invasive bladder cancer (MIBC).
The sBLA submission is supported by outcomes from the multi-centre, randomised, open-label Phase III NIAGARA trial involving 1,063 subjects.
Subjects were randomised to receive Imfinzi along with neoadjuvant chemotherapy before and after cystectomy, or to receive neoadjuvant chemotherapy alone before cystectomy without further treatment post-surgery.
Conducted across 192 centres in 22 regions and countries, including Asia, Australia, Europe, North America and South America, the dual primary endpoints of the global trial were event-free survival (EFS) and pathologic complete response, with safety and overall survival (OS) as key secondary endpoints.
Regulatory reviews based on this trial are also underway in Japan, the European Union (EU), and many other countries.
AstraZeneca Oncology research and development executive vice-president Susan Galbraith said: “New options for muscle-invasive bladder cancer are vital because nearly half of patients will see their cancer return or progress despite undergoing curative-intent treatment, including removal of their bladder.
“Today’s priority review designation recognises the urgent need for new options for these patients and the potential of Imfinzi to transform the standard of care as the first and only perioperative immunotherapy regimen to delay recurrence and extend survival in this setting.”
MIBC - in which the tumour has invaded the muscle wall of the bladder without distant metastases - affects one in four bladder cancer sufferers.
The current standard of care for the estimated 117,000 individuals treated in a curative-intent setting includes neoadjuvant chemotherapy and radical cystectomy. Despite this treatment, many face high recurrence rates and a poor prognosis.
The development follows US FDA approval of the therapy to treat limited-stage small-cell lung cancer (LS-SCLC) in the adult population.
