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FDA grants accelerated approval to Bavencio for advanced urothelial carcinoma
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The FDA granted accelerated approval to avelumab for the treatment of locally advanced or metastatic urothelial carcinoma, according to the drug’s manufacturer.
This approval of avelumab (Bavencio, EMD Serono) is indicated for patients with disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
Researchers of an open-label, single-arm, multicenter study evaluated avelumab — a fully human monoclonal antibody — in 242 patients with locally advanced or metastatic urothelial carcinoma.
Patients received 10 mg/kg IV avelumab 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.
Researchers reported an overall response rate of 13.3% (95% CI, 9.1-18.4) at 13 weeks of follow-up, and 16.1% (95% CI, 10.8-22.8) at 6 months of follow-up.
Median time to response was 2 months (range, 1.3-11); however, median response duration had not been reached in patients followed for at least 13 weeks or at least 6 months.
The most common adverse reactions included fatigue, infusion-related reaction, musculoskeletal pain, nausea, decreased appetite and urinary tract infection.
Deaths due to an adverse reaction occurred in 6% of patients. Further, 41% of patients experienced serious adverse reactions, which included 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 FDA recommended a dose of 10 mg/kg IV avelumab over 60 minutes every 2 weeks, premedicated with an antihistamine and acetaminophen prior to the first four infusions of avelumab.
The FDA had granted this application priority review. Avelumab also is approved for the treatment of patients aged 12 years and older with metastatic Merkel cell carcinoma.