FDA Grants Bladder Cancer Drug Accelerated Approval

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.