Sean Bohen, executive vice president, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “For patients who have not progressed following chemoradiation therapy the only current option is active monitoring. Unfortunately, for the majority of patients, their cancer will progress to metastatic disease, typically within 12 months. Imfinzi is the first immuno-oncology medicine to show a clinically-significant benefit in this earlier, non-metastatic setting, so following the Breakthrough Designation we hope to bring it to patients as soon as possible.”
The Breakthrough Therapy Designation is designed to expedite the development and regulatory review of new medicines that are intended to treat a serious condition and that have shown encouraging early clinical results.
The Breakthrough Therapy Designation for Imfinzi was granted on the basis of interim results from the Phase III PACIFIC trial.
This achievement follows the recent accelerated approval from the US FDA for Imfinzi in previously-treated patients with advanced bladder cancer, and is the fourth Breakthrough Therapy Designation AstraZeneca has received from the FDA for a New Oncology cancer medicine over the past three years and the second for Imfinzi.
Earlier, AstraZeneca shares fell after a late-stage trial that paired an AZ drug a Merck product proved to be disappointing
AstarZeneca has about 1,500 employees in Delaware, the home of its North American commercial headquarters.
