FDA Grants Bladder Cancer Drug Accelerated Approval

Avelumab (Bavencio) treats advanced or metastatic urothelial carcinoma that advanced during or after platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

Today, the FDA granted accelerated approval to avelumab (Bavencio) for patients with advanced or metastatic urothelial carcinoma whose disease advanced during or after platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

Avelumab is a PD-L1 inhibitor that is thought to prevent cancer cells from harnessing PD-L1 for protection against T cells. In March 2017, avelumab became the first immunotherapy to receive FDA approval for the treatment of metastatic Merkel cell carcinoma, a rare but aggressive type of skin cancer.

The latest approval was based on positive data from a clinical trial that included 242 patients with urothelial carcinoma whose disease was inadequately controlled by a platinum-containing chemotherapy regimen.

Patients received avelumab 10-mg/kg intravenously every 2 weeks until disease progression or toxicity. Prior to each intravenous administration, patients received an anti-histamine and acetaminophen.

The investigators found that 13.3% of patients followed for at least 13 weeks achieved a confirmed overall response rate and patients followed for at least 6 months achieved a 16.1% confirmed overall response rate, according to the FDA.

The positive results were typically seen 2 months into treatment. The median response duration had not been reached, but ranged from at least 1.4 months to more than 17.4 months, according to the release.

Approximately 6% of patients died as a result of an adverse reaction to the treatment, while 41% of patients reported a serious adverse reaction. The most frequent serious adverse reactions 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 reported.

Common adverse events observed in the clinical trial included fatigue, infusion-related reaction, musculoskeletal pain, nausea, decreased appetite, and urinary tract infection.

The drug was previously granted priority review for the urothelial carcinoma indication, and the approval comes approximately 3 months ahead of the goal date, the FDA concluded.