LONDON (dpa-AFX) - AstraZeneca Plc. (AZN.L, AZN) said that it has voluntary withdrawn the Imfinzi or durvalumab indication in the US for previously treated adult patients with locally advanced or metastatic bladder cancer.
The company noted that the withdrawal is aligned with the U.S. FDA guidance for evaluating indications with accelerated approvals that did not meet post-marketing requirements, as part of a broader industry-wide evaluation.
Imfinzi was granted accelerated approval in May 2017 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 Imfinzi in advanced solid tumours, including previously treated bladder cancer. Continued approval was contingent on results from the DANUBE Phase III trial in the 1st-line metastatic bladder cancer setting, which did not meet its primary endpoints in 2020.
According to the compny, the withdrawal does not impact the indication outside the US and does not impact other approved Imfinzi indications within or outside the US.
The company said it is notifying the update to healthcare providers. Patients with metastatic bladder cancer currently being treated with Imfinzi should consult with their healthcare provider regarding their ongoing care.
Imfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour's immune-evading tactics and releasing the inhibition of immune responses.
As part of a broad development progra, Imfinzi is being tested as a monotherapy and in combinations including with tremelimumab, an anti-CTLA4 monoclonal antibody and potential new medicine, as a treatment for patients with non-small cell lung cancer, small cell lung cancer, bladder cancer, liver cancer, biliary tract cancer, oesophageal cancer, gastric and gastroesophageal cancer, cervical cancer, ovarian cancer, endometrial cancer, and other solid tumours.
Copyright RTT News/dpa-AFX
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