FDA awards breakthrough therapy status to AstraZeneca's durvalumab in bladder cancer

The FDA granted breakthrough therapy designation to AstraZeneca's durvalumab for the treatment of patients with PD-L1 positive inoperable or metastatic urothelial bladder cancer whose tumour has progressed during or after one standard platinum-based regimen, the company reported Wednesday. The investigational human monoclonal antibody, also known as MEDI4736, is directed against programmed PD-L1.

AstraZeneca noted that the FDA's decision was based on early clinical data from a Phase I trial of durvalumab in patients with advanced metastatic urothelial bladder cancer whose tumour has progressed during or after one standard platinum-based regimen. The drugmaker indicated that results from the trial have been submitted for presentation at a future medical meeting.

Durvalumab is also being tested in first-line bladder cancer as a monotherapy, as well as in combination with Pfizer's investigational IgG2 monoclonal antibody tremelimumab as part of the DANUBE Phase III trial. Further, durvalumab is being investigated as monotherapy or in combination with tremelimumab in non-small-cell lung cancer, head and neck, gastric, pancreatic, hepatocellular carcinoma and blood cancers. However, in December last year, AstraZeneca announced that preliminary mid-stage study results are unlikely to support regulatory filings for durvalumab as a monotherapy in lung cancer.

For related analysis, see ViewPoints: Is it 'make or break' time for AstraZeneca's immuno-oncology strategy in lung cancer?

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