FDA Orphan Drug Designation Granted to Rucosopasem for Pancreatic Cancer
“Orphan drug designation for rucosopasem highlights the urgent need for more treatment options to extend survival in patients with pancreatic cancer, which is the fourth leading cause of cancer death in the U.S.,” said Mel Sorensen, M.D., Galera’s President and CEO. “Following our announcement of encouraging survival results from our pilot proof-of-concept trial in patients with LAPC in 2021, we initiated the GRECO-2 trial, which is currently enrolling. We believe rucosopasem has the potential to improve the efficacy of SBRT for pancreatic cancer, and we anticipate topline data from GRECO-2 by the end of next year.”
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.