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FDA Alerts
Hematology
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FDA recommends early termination of phase 2 trial of immunotherapy ERC1671 for glioblastoma

Posted on April 7, 2021

The U.S. Food and Drug Administration has recommended the early termination of the onging Phase 2 clinical trial for ERC1671 (ERC-USA), a cell-based immunotherapy, for the treatment of glioblastoma. The FDA recommended that a randomized confirmatory Phase 3 registration trial should be pursued, according to a press release.

Previous preliminary survival data demonstrated that treatment combined with bevacizumab maintained median overall survival of 11 months compared to historical controls demonstrating median overall survival of 5.3 months.

“We are highly reassured that the FDA shares our view that ERC1671 should enter a registration trial and move toward an NDA as soon as possible,” said principal investigator, Daniela A. Bota, MD, PhD, Vice Dean for Clinical Research, University of California, Irvine School of Medicine, and Medical Director, UCI Health Comprehensive Brain Tumor Program.

“We are thrilled that the FDA now recognizes the potential of ERC1671 to treat this intractable disease and major unmet medical need,” said Apostolos Stathopoulos, MD, PhD, President and CEO of ERC Belgium, parent company to ERC-USA. “We believe ERC1671 provides significant hope to patients with recurrent glioblastoma and we are grateful to the FDA’s encouragement to aggressively enter into a registration trial.”

Read the full press release here.

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