The U.S. Food and Drug Administration granted accelerated approval Tuesday to Bavencio, also called Avelumab, for patients suffering from advanced or metastatic urothelial carcinoma.
Bavencio is targeting patients with the disease which progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
The accelerated approval was based on data from 242 patients with locally advanced or metastatic urothelial carcinoma that enrolled on an open-label, single arm, multi-center study.
Patients received Bavencio, 10 mg/kg through their veins, every two weeks until radiographic or clinical progression occurs or unacceptable toxicity. All patients had received premedication with an antihistamine and acetaminophen before each Bavencio administration.
The confirmed overall response rate in patients had been followed for at least 13 weeks. The median time to response to the drug was two months.
About 6 percent of patients have died due to an adverse reaction, while serious adverse reactions were reported in 41 percent of patients. The most frequent serious adverse reactions reported in 2 percent or more of patients were urinary tract infection, abdominal pain, musculoskeletal pain, creatinine increased/renal failure, dehydration, urinary tract hemorrhage, intestinal obstruction/small intestinal obstruction, and pyrexia.
The most common adverse reactions that occurred in at least 20 percent of patients were fatigue, infusion-related reaction, musculoskeletal pain, nausea, decreased appetite, and urinary tract infection.
The recommended dose of Bavencio is 10 mg/kg as an intravenous infusion over 60 minutes every two weeks. Patients should also be pre-medicated with an antihistamine and acetaminophen before the first four infusions of Bavencio.