AstraZeneca has received the US Food and Drug Administration’s (FDA) acceptance and priority review for its supplemental biologics licence application (sBLA) for Imfinzi (durvalumab).
The drugmaker is seeking approval for Imfinzi to treat muscle-invasive bladder cancer (MIBC) patients.
The FDA’s action date under the Prescription Drug User Fee Act (PDUFA) is expected in Q2 2025.
The sBLA submission is supported by results from the Phase 3 NIAGARA trial, a multi-centre, randomised, open-label study with 1,063 participants.
In the trial, patients received Imfinzi combined with neoadjuvant chemotherapy before radical cystectomy, followed by Imfinzi as adjuvant monotherapy, or neoadjuvant chemotherapy alone before cystectomy.
The global trial had dual primary endpoints, event-free survival (EFS) and pathologic complete response (pCR). Safety and overall survival (OS) were key secondary endpoints.
A planned interim analysis showed that perioperative Imfinzi reduced the risk of disease progression, recurrence, surgery delays, or death by 32% compared to neoadjuvant chemotherapy with radical cystectomy alone.
The estimated median EFS was not yet reached for the Imfinzi arm, compared to 46.1 months for the comparator arm.
At two years, 67.8% of patients treated with Imfinzi were event-free, versus 59.8% in the comparator arm.
The key secondary endpoint of OS showed that the Imfinzi perioperative regimen reduced the risk of death by 25% when compared to the neoadjuvant chemotherapy with radical cystectomy group.
Regulatory applications based on the NIAGARA results are currently under review in the European Union (EU), Japan, and other countries.
AstraZeneca oncology research and development (R&D) executive vice president Susan Galbraith said: “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.”
Imfinzi is approved for various cancers, including unresectable Stage 3 non-small cell lung cancer (NSCLC), limited-stage small cell lung cancer (SCLC), advanced biliary tract cancer, unresectable hepatocellular carcinoma (HCC), and endometrial cancer.
Furthermore, durvalumab is being assessed in various cancers, including bladder, breast, gastrointestinal, and gynaecologic cancers.
In a separate development, AstraZeneca reported positive results from the AMPLIFY Phase 3 trial. It assessed Calquence (acalabrutinib) with venetoclax in previously untreated adult chronic lymphocytic leukaemia (CLL) patients.
As per the data, the Calquence combination significantly improved progression-free survival (PFS) compared to standard chemoimmunotherapy. It lowered the risk of disease progression or death by 58%.
