FDA authorizes Expanded Access Program for MNPR-101-Zr and MNPR-101-Lu in Advanced Cancers

“We are pleased to provide patients in the United States with access to MNPR-101-Zr and MNPR-101-Lu, which were developed to target aggressive cancers, such as triple-negative breast, pancreatic, and colorectal cancer,” said Andrew Cittadine, Chief Operating Officer of Monopar. “This EAP represents continued progress in our radiopharmaceutical pipeline following last year’s initiation of Phase 1 clinical trials in Australia with MNPR-101-Zr and MNPR-101-Lu. We are grateful for the opportunity to work with Dr. Delpassand to make these therapies available to patients on a compassionate use basis,” added Mr. Cittadine.

Share:

More News

“The designation reinforces the significant unmet need for effective treatment options for patients with advanced breast cancer,” said Charles Baum, M.D., Ph.D., Chief Executive Officer of Terremoto Biosciences. “We are committed to advancing highly selective therapies designed to expand treatment options for patients with difficult to treat cancers.”

“Up to five U.S. clinical sites are planned for THIO-101 Parts C and D this year, and we expect to activate a second U.S. site in the coming weeks,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. “To date, data has shown overall survival (OS) beyond two

Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said: “The positive CHMP opinion for the sqNSCLC indication marks another important milestone in serplulimab’s regulatory journey in Europe and brings the product one step closer to achieving comprehensive coverage of first-line lung cancer treatment indications in the EU.