The US Food and Drug Administration (FDA) has approved durvalumab — a PD-L1 inhibitor — for the treatment of locally advanced or metastatic urothelial carcinoma among patients whose disease progressed during or after platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant chemotherapy.1

The companion diagnostic, the VENTANA PD-L1 (SP263) Assay, was also approved for the evaluation of PD-L1 protein expression of urothelial carcinoma tissue.

Durvalumab is recommended every 2 weeks at a 10 mg/kg intravenous infusion over 60 min until disease progression or unacceptable toxicity.

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Durvalumab was approved based on a single-arm trial of 182 patients, in which the confirmed objective response (ORR) rate by independent central review was 17% (95% CI, 11.9-23.3%).

In the study, the ORR was highest among patients with higher PD-L1 expression levels. The ORR was 26.3% (95% CI, 17.8-36.4) among patients with a high score and 4.1% (95% CI, 0.9-11.5) among patients with a low or negative score.

The median duration of response was not reached at data cutoff and had a range of 0.9+ to 19.9+ months.

RELATED: FDA Grants Priority Review to Avelumab for Urothelial Carcinoma

The FDA granted durvalumab an accelerated approval after being granted Breakthrough Therapy Designation and is contingent on confirmation of clinical benefit from an ongoing clinical trial.

Prescribing information can be found here.


  1. Durvalumab (Imfinzi) [news release]. Silver Spring, MD: US Food and Drug Administration; May 1, 2017. Accessed May 1, 2017.