FDA News

FDA grants breakthrough therapy designation to durvalumab for bladder cancer

The FDA today granted breakthrough therapy designation to durvalumab for the treatment of patients with programmed death ligand-1–positive inoperable or metastatic urothelial bladder cancer whose tumor has progressed during or after one standard platinum-based regimen.

The designation was granted based on early clinical data from a phase 1 trial evaluating durvalumab (MEDI4736, AstraZeneca and MedImmune) — a human monoclonal antibody directed against programmed death ligand-1 (PD-L1) — in patients with advanced metastatic urothelial bladder cancer.

The drug blocks the PD-L1 interaction with PD-1, countering the tumor's immune-evading tactics so the patient's immune system can attack the cancer.

“Metastatic bladder cancer is an area of enormous unmet medical need,” Robert Iannone, senior vice president and head of immuno-oncology for global medicines development at AstraZeneca, said in a press release. “We are encouraged by this breakthrough therapy designation. We look forward to working closely with the FDA to bring durvalumab to bladder cancer patients as soon as possible.”

Durvalumab also is being tested in first-line bladder cancer as a monotherapy, as well as in combination with tremelimumab (AstraZeneca and MedImmune) in non–small cell lung cancer, head and neck cancer, bladder cancer, gastric cancer, pancreatic cancer, hepatocellular carcinoma and blood cancers as part of the DANUBE phase 3 trial.

The FDA today granted breakthrough therapy designation to durvalumab for the treatment of patients with programmed death ligand-1–positive inoperable or metastatic urothelial bladder cancer whose tumor has progressed during or after one standard platinum-based regimen.

The designation was granted based on early clinical data from a phase 1 trial evaluating durvalumab (MEDI4736, AstraZeneca and MedImmune) — a human monoclonal antibody directed against programmed death ligand-1 (PD-L1) — in patients with advanced metastatic urothelial bladder cancer.

The drug blocks the PD-L1 interaction with PD-1, countering the tumor's immune-evading tactics so the patient's immune system can attack the cancer.

“Metastatic bladder cancer is an area of enormous unmet medical need,” Robert Iannone, senior vice president and head of immuno-oncology for global medicines development at AstraZeneca, said in a press release. “We are encouraged by this breakthrough therapy designation. We look forward to working closely with the FDA to bring durvalumab to bladder cancer patients as soon as possible.”

Durvalumab also is being tested in first-line bladder cancer as a monotherapy, as well as in combination with tremelimumab (AstraZeneca and MedImmune) in non–small cell lung cancer, head and neck cancer, bladder cancer, gastric cancer, pancreatic cancer, hepatocellular carcinoma and blood cancers as part of the DANUBE phase 3 trial.