Sevabertinib, a potential treatment for HER2-mutant non-small cell lung cancer (NSCLC), has received priority review designation from the FDA. Christine Roth of Bayer highlighted the significance of this milestone, emphasizing the unmet need and potential of sevabertinib to improve outcomes for patients. If approved, sevabertinib could address critical unmet needs and offer hope to a […]
Category: Priority Review
FDA Priority Review for Sevabertinib NDA in HER2 Lung Cancer
Sevabertinib, an investigational oral treatment, is under Priority Review by the FDA for patients with HER2+ non-small cell lung cancer (NSCLC) and other solid tumors harboring HER2-activating mutations. Developed through a research collaboration between Bayer and the Broad Institute of MIT and Harvard, Sevabertinib is a reversible tyrosine kinase inhibitor (TKI) specifically designed to target […]
FDA Prioritizes TransCon® CNP NDA Review
The FDA has accepted the New Drug Application (NDA) for TransCon CNP, a treatment for children with achondroplasia, for priority review. This decision highlights the potential of TransCon CNP in addressing serious complications of achondroplasia and improving health outcomes compared to current therapies. Ascendis Pharmaceuticals aims to collaborate with the FDA to expedite the availability […]
FDA Grants Priority Review for Ziftomenib in NPM1-Mutant AML
The FDA has granted priority review to the new drug application (NDA) of Ziftomenib for patients with NPM1-mutant acute myeloid leukemia (AML). This decision signifies a crucial advancement in providing potential treatment options for individuals facing this aggressive form of AML. Dr. Troy Wilson, president of Kura Oncology, emphasized the significant impact this milestone holds […]
