FDA okays AstraZeneca’s bladder cancer drug Imfinzi Plus BCG
First immunotherapy combination approved in the US for BCG-naïve high-risk NMIBC demonstrates a 32% reduction in the risk of disease recurrence, progression, or death
First immunotherapy combination approved in the US for BCG-naïve high-risk NMIBC demonstrates a 32% reduction in the risk of disease recurrence, progression, or death
The study tracked patients for more than five years (median 60.7 months), with protection against disease returning emerging in under four months and continuing long term
The study has shown that perioperative treatment with Imfinzi (durvalumab), alone or in combination with other immunotherapy agents
AstraZeneca says the approval strengthens its push to bring immunotherapy earlier into cancer treatment, where long-term cures are possible
The study is a collaboration between AIM, AstraZeneca, and Erasmus Medical Center in the Netherlands
OS is a key secondary endpoint of the 948-patient study, which is evaluating whether adding AstraZeneca's PD-L1 inhibitor to standard FLOT chemotherapy
Adding one year of Imfinzi treatment to Bacillus Calmette-Guérin (BCG) induction and maintenance therapy delivered an early and sustained disease-free survival benefit vs. BCG alone
For patients with resectable early-stage gastric and gastroesophageal junction cancers
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
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