FDA Grants Accelerated Approval to Avelumab for Urothelial Carcinoma

Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to avelumab (Bavencio) for patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

JAVELIN Solid Tumor Trial

Approval was based on data from the open-label, single arm, multicenter JAVELIN Solid Tumor Trial. The study enrolled 242 patients with locally advanced or metastatic urothelial carcinoma whose disease progressed on or after platinum-based therapy or within 12 months of a platinum-containing neoadjuvant or adjuvant chemotherapy regimen. Patients received avelumab, 10 mg/kg intravenously, every 2 weeks until radiographic or clinical progression or unacceptable toxicity. All patients received premedication with an antihistamine and acetaminophen prior to each avelumab administration.

Confirmed overall response rate (ORR) in patients who had been followed for at least 13 weeks was 13.3% (n = 30) (95% confidence interval [CI] = 9.1–18.4), and 16.1% (n = 26) (95% CI = 10.8–22.8) in patients who had been followed for at least 6 months. Median time to response was 2.0 months (range = 1.3–11.0). The median response duration had not been reached in patients followed for at least 13 weeks or at least 6 months, but ranged from 1.4+ to 17.4+ months in both groups.

Deaths due to an adverse reaction occurred in 6% of patients. Serious adverse reactions were reported in 41% of patients. The most frequent serious adverse reactions reported in 2% or more of patients were urinary tract infection/urosepsis, abdominal pain, musculoskeletal pain, creatinine increased/renal failure, dehydration, hematuria/urinary tract hemorrhage, intestinal obstruction/small intestinal obstruction, and pyrexia. The most common adverse reactions that occurred in at least 20% of patients were fatigue, infusion-related reaction, musculoskeletal pain, nausea, decreased appetite, and urinary tract infection.

The recommended dose of avelumab is 10 mg/kg as an intravenous infusion over 60 minutes every 2 weeks. Premedicate with an antihistamine and acetaminophen prior to the first four infusions of avelumab.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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