Approval based on NIAGARA Phase III trial results which showed a 32% reduction in the risk of recurrence and a 25% reduction in the risk of death for the Imfinzi regimen vs. neoadjuvant chemotherapy alone
Imfinzi reduced the risk of distant metastases and death from bladder cancer vs. neoadjuvant chemotherapy alone
If approved, sasanlimab would be the first PD-1 inhibitor, in combination with BCG, to significantly prolong event-free survival in this patient population
First immunotherapy regimen before and after surgery to extend survival in bladder cancer
If approved, enfortumab vedotin with KEYTRUDA would be the first combination in China to offer an alternative to chemotherapy
Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival
Researchers presented these bladder cancer study findings at the 117th Annual Scientific Meeting of the American Urological Association (AUA)
Pangea will use its integrated validation platform and regulatory expertise to oversee analytical and clinical validation of Gene Solutions’ multi-omics technologies.
The study evaluated patients with stage III/IV melanoma after complete tumor resection
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