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On May 9, 2017, the U.S. Food and Drug Administration granted accelerated approval to 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.
This follows an accelerated approval in March for avelumab to treat Merkel cell carcinoma.
Approval against urothelial carcinoma was based on data from an open-label, single arm, multi-center study that 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 pre-medication with an anti-histamine 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% 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, haematuria/urinary tract haemorrhage, 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.
Source: FDAhttp://ecancer.org/news/11306-fda-grants-avelumab-accelerated-approval-for-merkel-cell-carcinoma.php
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