FDA has granted Breakthrough Therapy designation to Durvalumab for treatment of patients with PD-L1 positive urothelial bladder cancer
The FDA ( Food and Drug Administration ) 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 whose tumour 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.
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 whose tumour has 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.
Durvalumab is an investigational human monoclonal antibody directed against programmed death ligand-1 ( PD-L1 ). PD-L1 can be expressed by tumours 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 tumour's immune-evading tactics.
Durvalumab is being investigated in an extensive clinical trial programme, as monotherapy or in combination with Tremelimumab, in NSCLC, head and neck, bladder, gastric, pancreatic, hepatocellular carcinoma and blood cancers. ( Xagena )
Source: AstraZeneca, 2016