FDA Approves Durvalumab (Imfinzi) for Urothelial Cancer

Nick Mulcahy


May 01, 2017

The US Food and Drug Administration (FDA) today granted accelerated approval to durvalumab (Imfinzi, AstraZeneca) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with that chemotherapy.

The FDA also approved the Ventana PD-L1 Assay (Ventana Medical Systems) as a complementary diagnostic test for assessing the programmed cell death ligand-1 (PD-L1) protein in urothelial carcinoma tissue.

Urothelial cancers include carcinomas of the bladder, which are most common, as well as the ureters and renal pelvis.

The new drug joins atezolizumab (Tecentriq, Genentech) and nivolumab (Opdivo, Bristol-Myers Squibb) as immunotherapies approved in this setting.

Approval was based on one single-arm trial of 182 patients with locally advanced or metastatic urothelial carcinoma whose disease progressed after prior platinum-containing chemotherapy.

Objective response rate (ORR) as assessed and confirmed by blinded independent central review was 17.0%. The median response duration was not reached (range, 0.9+ to 19.9+ months).

ORR was also analyzed by PD-L1 expression status, as measured by the approved assay. Among the 182 patients, the confirmed ORR was 26.3% in 95 patients with a high PD-L1 score and 4.1% in 73 patients with a low or negative PD-L1 score.

The most common adverse reactions (≥15% of patients) were fatigue, musculoskeletal pain, constipation, decreased appetite, nausea, peripheral edema, and urinary tract infection. Serious, grade 3 to 4 adverse events were seen in 43% of patients. Infection and immune-related adverse events, including pneumonitis, hepatitis, colitis, thyroid disease, adrenal insufficiency, and diabetes, were also seen with durvalumab.

The recommended dose of durvalumab is 10 mg/kg, administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.

Full prescribing information is available online.

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