AstraZeneca has picked up its fourth Breakthrough Therapy Designation for a new oncology medicine in three years after the US FDA rubberstamped Imfinzi.
Imfinzi has been granted the designation for the treatment of patients with locally-advanced, unresectable non-small cell lung cancer whose disease has not progressed following platinum-based chemoradiation therapy.
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 designation for Imfinzi was granted on the basis of interim results from the Phase III PACIFIC trial – a randomised, double-blinded, placebo-controlled multi-centre trial.
This follows the recent accelerated FDA approval from the US FDA for Imfinzi in previously-treated patients with advanced bladder cancer.
It is also the fourth Breakthrough Therapy Designation AZ has received for a New Oncology cancer medicine over the past three years, the second for Imfinzi.