US Breakthrough designation for AstraZeneca's durvalumab

The US Food and Drug Administration has granted Breakthrough Therapy designation (BTD) for durvalumab (MEDI4736), a system which is designed to expedite the development of new drugs.

Durvalumab is AstraZeneca’s (LSE: AZN) 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 tumor has progressed during or after one standard platinum-based regimen. The news saw the Anglo-Swedish pharma major’s shares rise 1.4% to £42.42 by midday.

Robert Iannone, senior vice president, head of Immuno-Oncology, Global Medicines Development at AstraZeneca, said: “Metastatic bladder cancer is an area of enormous unmet medical need. 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.”