Drug Approval | January 31, 2024
Enhertu granted Priority Review in the US for patients with metastatic HER2-positive solid tumours
Submission to be reviewed under FDA real-time oncology review and Project Orbis
Submission to be reviewed under FDA real-time oncology review and Project Orbis
Submission based on positive results from global phase 3 study demonstrating overall survival benefit of TIVDAK over chemotherapy
If approved, Xolair would be the first medicine to reduce allergic reactions to multiple foods following an accidental exposure
Jemperli is the only immuno-oncology treatment approved in the frontline setting for this patient population in combination with chemotherapy
Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities
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 sBLA submission is supported by clinical, pre-clinical, and manufacturing data demonstrating the safety, tolerability, and immunogenicity of the bivalent vaccine.
This combination has the potential to be the first treatment option combining an antibody-drug conjugate plus an immunotherapy in this treatment setting
Patients receiving Polivy plus R-CHP for DLBCL reported similar health-related quality of life outcomes
Acceptance based on results from the phase 3 KEYNOTE-091 trial
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