FDA Approves New Treatment for Urothelial Carcinoma

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

Durvalumab is administered as an intravenous infusion at a recommended dosage of 10 mg/kg over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.
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FDA Approves New Option for Urothelial Carcinoma
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Approval for durvalumab was based on the finding of a single-arm trial that included 182 patients with locally advanced or metastatic urothelial carcinoma that progressed after platinum-containing chemotherapy. Participants were administered 10mg/kg dose of durvalumab intravenously every 2 weeks. The objective response rate (ORR), as analyzed by PD-L1 expression status, showed that 95 patients with high PD-L1 score had a confirmed ORR of 26.3% and 73 patients with low or negative PD-L1 score had a confirmed ORR of 4.1%.

The most common adverse events associated with durvalumab that occurred in at least 15% of patients were fatigue, musculoskeletal pain, constipation, decreased appetite, nausea, peripheral edema, and urinary tract infection.

Grade 3 and 4 adverse events were observed in 43% of patients. In addition, pneumonitis, hepatitis, colitis, thyroid disease, adrenal insufficient, and diabetes were also associated with durvalumab.

—Melissa Weiss

Reference:

Durvalumab (Imfinzi) [press release]. FDA. May 1, 2017. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm555930.htm.