Durvalumab Granted Breakthrough Therapy Designation by US FDA for Treatment of Patients with PD-L1 Positive Urothelial Bladder Cancer

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for durvalumab (MEDI4736), an investigational human monoclonal antibody directed against programmed death ligand-1 (PD-L1), for the treatment of patients with PD-L1 positive inoperable or metastatic urothelial bladder cancer that has progressed during or after one standard platinum-based regimen.

The Breakthrough Therapy Designation is designed to expedite the development of new drugs which are intended to treat a serious condition and which have shown encouraging early clinical results, which demonstrate substantial improvement on a clinically significant endpoint over available therapies or when there is significant unmet medical need.

About bladder cancer

Urothelial carcinoma (formerly known as transitional cell carcinoma) is a cancer involving parts of the kidney, bladder, and ureter (the tube that connects the kidney to the bladder). Urothelial carcinomas begin in the cells that line the particular organ in which the cancer develops.

Urothelial carcinoma is the most common type of bladder cancer. If bladder cancer is detected and treated early, cure rates are high. However, once bladder cancer has spread outside of the bladder to distant sites in the body, effective treatment options remain limited, particularly if a patient experiences a cancer recurrence following prior therapies. Urothelial bladder cancer is the 9th most common form of cancer worldwide, and metastatic bladder cancer remains an area of great unmet medical need with 5-year overall survival rates of less than 15%.

About durvalumab (MEDI4736)

Durvalumab is an investigational human monoclonal antibody directed against programmed death ligand-1 (PD-L1). PD-L1 can be expressed by tumors to evade detection by the immune system through binding to PD-1 on cytotoxic T lymphocytes. Durvalumab blocks the PD-L1 interaction with PD-1, countering the tumor’s immune-evading tactics. Durvalumab is being developed, alongside other immunotherapies, to empower the patient’s immune system and attack the cancer.

The Breakthrough Therapy Designation for durvalumab was granted by the FDA on the basis of early clinical data from a Phase I trial (Study 1108) in patients with advanced metastatic urothelial bladder cancer that had progressed during or after one standard platinum-based regimen. Durvalumab is also being tested in first-line bladder cancer as a monotherapy as well as in combination with tremelimumab as part of the DANUBE Phase III trial which achieved first patient in during the final quarter of 2015.

Reference: AstraZeneca news release. (2016.) Retrieved from: https://www.astrazeneca.com/our-company/media-centre/press-releases/2016/Durvalumab-granted-Breakthrough-Therapy-designation-by-US-FDA-for-treatment-of-patients-with-PD-L1-positive-urothelial-bladder-cancer-17022016.html

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