Acceptance based on results from the Phase 3 KEYNOTE-859 trial, which showed significant overall survival benefit in these patients with HER2-negative disease, regardless of PD-L1 expression
This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency
Astellas stands on the forefront of healthcare change to turn innovative science into value for patients
FDA also accepts a separate supplemental application to extend prophylaxis with PREVYMIS to 200 days in certain HSCT recipients
If approved, the vaccine could help simplify the meningococcal vaccination schedule and provide the broadest serogroup coverage of any meningococcal vaccine
This combination has the potential to be the first treatment option combining an antibody-drug conjugate plus an immunotherapy in this treatment setting
Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints
This is the third major regulatory milestone for the vaccine candidate following acceptance of regulatory submissions in Europe and Japan
Submission based on QuANTUM-First results showing quizartinib plus chemotherapy significantly improved overall survival compared to chemotherapy alone
Coordinated by the Medical University of Vienna, a consortium of 13 leading European organizations including university hospitals, research institutions and healthcare companies will conduct the 5-year project co-funded by Horizon Europe.
Subscribe To Our Newsletter & Stay Updated
