It looks like your browser is not up to date.
This means our website may not look and work as you would expect. Read more about browsers and how to update them here.

Skip to main content
  • Register
  • Help
  • Contact us

AstraZeneca withdraws Imfinzi US indication for advanced bladder cancer

Mon 22 February 2021 08:04 | A A A

No recommendation

No news or research item is a personal recommendation to deal. Hargreaves Lansdown may not share ShareCast's (powered by Digital Look) views.

(Sharecast News) - Drugmaker AstraZeneca announced the voluntary withdrawal of its Imfinzi indication in the US for previously treated adult patients with locally advanced or metastatic bladder cancer on Monday.

AstraZeneca, which stated its decision was made in consultation with the Food and Drug Administration, stated that Imfinzi was granted accelerated approval in the US based on promising tumour response rates and duration of response data from Study 1108, a Phase I/II trial that evaluated the safety and efficacy of the drug in advanced solid tumours.

However, the FTSE 100-listed group noted that continued approval was contingent on results from its DANUBE Phase III trial in the first-line metastatic bladder cancer setting, which failed to meet its primary endpoints in 2020.

Despite the setback in the US, AstraZeneca pointed out that the withdrawal did not impact the drug's indication outside the States.

As of 0820 GMT, AstraZeneca shares were up 0.39% at 7,254.0p.

    The value of investments can go down in value as well as up, so you could get back less than you invest. It is therefore important that you understand the risks and commitments. This website is not personal advice based on your circumstances. So you can make informed decisions for yourself we aim to provide you with the best information, best service and best prices. If you are unsure about the suitability of an investment please contact us for advice.

    More company news from ShareCast