> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Accelerated Approval for EMD Serono’s Bavencio
- URL: https://www.fdaweb.com/fda-accelerated-approval-for-emd-seronos-bavencio/
- Published: 2017-05-09T12:00:00.000Z
- Updated: 2026-09-14T22:22:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138645

FDA has granted accelerated approval to an EMD Serono NDA for Bavencio (avelumab) 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. Approval was supported by data from an open-label, single arm, multi-center study that enrolled 242 patients with locally advanced or metastatic urothelial carcinoma, an [FDA release](https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm557162.htm?ref=fdaweb.com) says. Confirmed overall response rate in patients who had been followed for at least 13 weeks was 13.3% and 16.1% in patients who had been followed for at least six months. Median time to response was two months, it says.

  
FDA says that deaths due to an adverse reaction occurred in 6% of patients, and 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.