AstraZeneca's Imfinzi fails bladder cancer trial — in patient population covered by FDA's 2017 accelerated approval
A post-approval commitment testing Imfinzi in a late-stage bladder cancer population has gone pear-shaped for AstraZeneca, as the checkpoint inhibitor failed to help patients live longer in an open-label pivotal study.
Back in 2017, the PD-L1 drug was granted accelerated approval by the FDA for patients with locally advanced or metastatic bladder cancer whose disease has persisted despite platinum-containing chemotherapy on the basis of Phase I/II data.
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