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FDA approves avelumab for advanced bladder cancer

Posted on July 1, 2020

The U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application for avelumab (Bavencio) for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy, according to a press release.

Approval is based on results from the Phase III JAVELIN Bladder 100 study, which compared patients treated with avelumab as first-line maintenance with best supportive care to patients receiving best supportive care alone. Those in the treatment group had a significant 7.1-month improvement in median overall survival (OS) compared with best supportive care alone (21.4 months vs 14.3 months, respectively). There was a 31% reduction in the risk of death in the overall population.

“As the first immunotherapy to demonstrate a statistically significant improvement in overall survival in the first-line setting in locally advanced or metastatic urothelial carcinoma, the FDA approval of avelumab is one of the most significant advances in the treatment paradigm in this setting in 30 years,” said Petros Grivas, MD, PhD, one of the principal investigators in the JAVELIN Bladder 100 trial in the press release. “With median overall survival of more than 21 months measured from randomization, the longest overall survival in a Phase III trial in advanced urothelial carcinoma, the JAVELIN Bladder 100 regimen with avelumab as a first-line switch maintenance treatment has the potential to become a new standard of care based on its proven ability to reinforce the benefit (response or stable disease) of induction chemotherapy and extend the lives of patients with this devastating disease.”

Read the full press release here.

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