Acceptance based on results demonstrated a statistically significant improvement in overall survival versus chemotherapy alone in these patients
TIVDAK is the first antibody-drug conjugate (ADC) to have positive overall survival data for patients with previously treated recurrent or metastatic cervical cancer
Sales reflect continued strong growth in oncology and vaccines
If approved, enfortumab vedotin with KEYTRUDA would be the first combination in China to offer an alternative to chemotherapy
Submission to be reviewed under FDA real-time oncology review and Project Orbis
If approved, Xolair would be the first medicine to reduce allergic reactions to multiple foods following an accidental exposure
The sBLA is supported by a usability study which confirmed that individuals over 18 years of age could self-administer
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
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