U.S. FDA approves durvalumab (durvalumab) for the treatment of muscle-invasive bladder cancer

On 20253month28, the U.S. Food and Drug Administration approved durvalumab (durvalumab) ( pan>durvalumab) as neoadjuvant therapy in combination with gemcitabine and cisplatin, followed by single-agent durvalumab as adjuvant therapy after radical cystectomy for the treatment of muscle-invasive bladder cancer (MIBC) in adult patients.

NIAGARA (NCT03732677) is a randomized, open-label, multicenter Phase III trial to evaluate efficacy in 1,063 patients who were candidates for radical cystectomy and had not received systemic therapy for bladder cancer. Patients were randomized in a 1:1 ratio to receive neoadjuvant durvalumab combined with chemotherapy and postoperative adjuvant durvalumab treatment, or neoadjuvant chemotherapy and postoperative surgery alone.

The primary efficacy outcome was event-free survival by blinded independent central review (EFS). Overall survival (OS) is another efficacy outcome. In a prespecified interim analysis, the trial showed statistically significant improvements in EFS and OS . durvalumab The median EFS was not reached in the combination chemotherapy group (NR) (95% CI: NR, NR) and the median EFS was in the chemotherapy group 46.1 months (95% CI: 32.2, NR) (hazard ratio 0.68 [95% CI: 0.56, 0.82]; bilateral p Value <0.0001). Median OS was not reached in either group (hazard ratio 0.75 [95% CI: 0.59, 0.93] ; bilateral p value = 0.0106).

For patients weighing≥30 kg, the recommended dose is 1,500 every3weeks mg, in combination with chemotherapy (neoadjuvant therapy) and 1,500 mg every4weeks (monotherapy) (adjuvant therapy). For patients weighing <30 kg, the recommended dose is 20 mg/kg every 3 weeks in combination with chemotherapy (neoadjuvant therapy) and 20 mg/kg every 4 weeks mg/kg (monotherapy) (adjuvant therapy). Treatment should be continued until disease has progressed beyond definitive surgery, recurrence or toxicity is unacceptable, or for a maximum of 8 cycles after surgery.

References: https://www.fda.gov/drugs/resources-information-approved-drugs