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.
