Last edition
News about "supplemental Biologics License Application (sBLA) "
US FDA Accepts Roche's Lunsumio-Polivy Filing for Relapsed Large B-Cell Lymphoma
The US Food and Drug Administration (FDA) has accepted Roche’s supplemental Biologics License Application for the Lunsumio and Polivy combination in relapsed or refractory large B-cell lymphoma. The filing is supported by Phase 3 SUNMO study data showing a 59 percent reduction in the risk of disease progression or death.
Supplemental Biologics License Application (sBLA) | 19/06/2026 | By News Bureau
US FDA Grants Priority Review for Enhertu + Pertuzumab in HER2+ Metastatic Breast Cancer
The US FDA has granted Priority Review to Enhertu + Pertuzumab for HER2+ metastatic breast cancer, following DESTINY-Breast09 trial results showing a 44 percent reduction in risk of disease progression or death and over three years’ median Progression-Free Survival (PFS), positioning it as a potential new first-line standard of care.
Supplemental Biologics License Application (sBLA) | 25/09/2025 | By Dineshwori | 175
We use our own and third party cookies to produce statistical information and show you personalized advertising by analyzing your browsing, according to our COOKIES POLICY. If you continue visiting our Site, you accept its use.
More information: Privacy Policy