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AstraZeneca to pull bladder cancer drug in US after disappointing study results
StockMarketWire.com
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Pharmaceutical giant AstraZeneca said it is withdrawing a bladder cancer drug in the US after it failed to meet post-marketing requirements in a recent clinical study.
Continued approval of Imfinzi was contingent on results from the DANUBE phase 3 trial in the 1st-line metastatic bladder cancer setting, which did not meet its primary endpoints in 2020, the company said.
'The withdrawal is aligned with FDA guidance for evaluating indications with accelerated approvals that did not meet post-marketing requirements, as part of a broader industry-wide evaluation,' it added.
The withdrawal did not impact the indication outside the US and does not impact other approved Imfinzi indications within or outside the US.
Story provided by StockMarketWire.com
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