FDA Grants Priority Review for Zolbetuximab Biologics License Application

“Astellas is committed to bringing innovative therapies to patients with hard-to-treat cancers, including gastric cancer. While rare in the U.S., gastric cancer can be deadly when diagnosed in the late stages,” said Moitreyee Chatterjee-Kishore, PhD, MBA, Senior Vice President and Head of Immuno-Oncology Development, Astellas. “The FDA’s acceptance of the Biologics License Application filing and Priority Review designation for zolbetuximab confirms the urgent therapeutic need and brings us one step closer to delivering on this commitment to patients, families and caregivers.”

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