AZ’s durvalumab awarded breakthrough status in bladder cancer
pharmafile | February 18, 2016 | News story | Research and Development | AstraZeneca, FDA, bladder cancer
AstraZeneca, and its biologics/R&D arm MedImmune, have won FDA Breakthrough Therapy status for their bladder cancer drug durvalumab (MEDI4736), which it is hoped will speed the treatment’s way through the regulatory pathway to patients.
Durvalumab acts against programmed death ligand-1 (PD-L1), which is used by tumours to evade the body’s immune system. The Breakthrough designation awarded is in treating to treat patients with PD-L1 positive inoperable or metastatic urothelial bladder cancer whose tumour has progressed during or after one standard platinum-based chemotherapy regimen.
Robert Iannone, senior vice president, head of Immuno-Oncology, Global Medicines Development at AstraZeneca, says: “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.”
The FDA awards Breakthrough Therapy status to new drugs that have shown encouraging early-stage clinical results, demonstrating substantial improvements over currently-available treatments. Metastatic bladder cancer remains an area of great unmet medical need with five-year overall survival rates of less than 15%.
This is the third Breakthrough Therapy designation AstraZeneca has received from the FDA for oncology medicines, and the company said the latest offered the opportunity for further collaboration with the FDA for the durvalumab development programme.
Durvalumab is also being tested in first-line bladder cancer as a monotherapy as well as in combination with tremelimumab-which AZ licensed from Pfizer in 2011- as part of the DANUBE Phase III trial which began enrolling patients in Q4 2015.
Durvalumab is also being investigated in trials for lung, head and neck, bladder, gastric, pancreatic, HCC and blood cancers.
Joel Levy
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