FDA Accepts BLA for Durvalumab in Bladder Cancer

December 14, 2016

The US Food and Drug Administration has accepted the first Biologics License Application for durvalumab (MEDI4736) to treat patients with urothelial cancer (UC) for whom cisplatin failed to stop disease progression.

The US Food and Drug Administration (FDA) has accepted the first Biologics License Application (BLA) for durvalumab (MEDI4736) to treat patients with  urothelial cancer (UC) for whom cisplatin failed to stop disease progression. The current standard of care for these patients with inoperable or advanced metastatic disease is systemic platinum-based chemotherapy, so this new treatment may be promising for patients who have been previously treated.

The FDA also granted priority review status with a Prescription Drug User Fee Act (PDUFA) set for the second quarter of 2017. This act authorizes the FDA to collect fees from companies that produce certain human drug and biological products, which helps to speed up the drug approval process.

The BLA submission, for the treatment of patients with locally advanced or metastatic UC whose disease has progressed during or after one standard platinum-based regimen, is based on the results of the UC cohort of Study 1108 (phase I/II multicenter, open-label, dose-escalation, and dose-expansion study investigating the safety and efficacy of durvalumab in adult patients with inoperable or metastatic solid tumors) and follows the FDA’s February 2016 Breakthrough Therapy Designation for durvalumab, a PD-L1 human monoclonal antibody (mAb).

This most common type of bladder cancer, also known as known as transitional cell carcinoma (TCC), starts in the urothelial cells that line the inside of the bladder, according to the American Cancer Society. Urothelial cells also line other parts of the urinary tract, such as the ureters and the urethra. Patients with bladder cancer sometimes have other tumors in these places, so the entire urinary tract needs to be checked for tumors.

“The BLA acceptance represents an exciting advance for our Immuno-Oncology medicines as we continue to develop chemotherapy-free treatments based on the potential clinical benefits of durvalumab, both as monotherapy and in combination,” said Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, in a news release.

Durvalumab is being tested as monotherapy and in combination with tremelimumab (CTLA-4 mAb) in the phase III DANUBE trial as first-line treatment for patients with metastatic UC, regardless of eligibility for cisplatin-based chemotherapy.