Rinatabart Sesutecan FDA Fast Track Designation for Patients with Advanced Ovarian Cancer
“Our receipt of Fast Track designation from the FDA underscores our belief in the tremendous promise of Rina-S as a potential best-in-class FRα ADC to address the significant need for improved treatment options for advanced ovarian cancer,” said Naomi Hunder, Chief Medical Officer of ProfoundBio. “FRα is a highly prevalent antigen in ovarian cancer and Rina-S has shown encouraging antitumor activity and tolerability in our Phase 1 dose escalation study in ovarian and endometrial cancer patients across the full spectrum of FRα expression. We look forward to working closely with the FDA as we progress further clinical development and registrational studies for Rina-S.”
Share:
More News
Paul Hudson, CEO of Sanofi, commented, “The proposed acquisition of Blueprint Medicines represents a strategic step forward in our rare and immunology portfolios. It enhances our pipeline and accelerates our transformation into the world’s leading immunology company. This acquisition is fully aligned with our strategic intent to strengthen our existing
Adam Pearson, Chief Strategy Officer, Astellas commented, “Astellas is dedicated to advancing innovative therapies for some of the most challenging-to-treat cancers, such as gastric and pancreatic cancer. XNW27011 is a promising new asset that complements Astellas’ pipeline and enhances our leading position in precision oncology. We look forward to harnessing
“We were honored to present our latest research at the American Academy of Neurology Annual Meeting,” said Jay Hartenbach, President and Chief Operating Officer of Diakonos Oncology. “Glioblastoma remains one of the most aggressive and challenging cancers to treat, and we are committed to advancing novel immunotherapy approaches that have
“Patients with HER2-mutant NSCLC are predominantly women, may be of younger age and non-smokers. The FDA’s decision to grant Priority Review designation to our application for sevabertinib is a significant milestone that validates both the unmet need and the potential for sevabertinib to fulfill that need,” said Christine Roth, Executive
