Submission based on positive results from global phase 3 study demonstrating overall survival benefit of TIVDAK over chemotherapy
TALZENNA is the first and only PARP inhibitor approved in combination with standard of care XTANDI for mCRPC patients in the European Union
Approval based on results from the Phase 3 KEYNOTE-859 trial, which demonstrated significant improvement in overall survival in these patients versus chemotherapy alone
Approval based on results from TOPAZ-1 global Phase III trial and a Chinese patient
With the establishment of five different precious metals alloy powder production methods
SKYSCRAPER-01 is ongoing and the study remains blinded to patients and investigators
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
First approved therapeutic regimen that combines an anti-PD-1 and an antibody-drug conjugate in the US in these patients
First approval for Daiichi Sankyo and AstraZeneca’s ENHERTU in China
New subgroup analysis from Phase III ARASENS trial shows that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel increased overall survival (OS)
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