Posted by Michael Wonder on 31 Jul 2017
Imfinzi granted breakthrough therapy designation by US FDA for patients with locally-advanced unresectable non-small-cell lung cancer
31 July 2017 - Fourth breakthrough therapy designation for an AstraZeneca new oncology medicine in three years.
AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US FDA has granted Breakthrough Therapy Designation for Imfinzi (durvalumab) for the treatment of patients with locally-advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemo-radiation therapy.
The breakthrough therapy 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 of Imfinzi as sequential treatment in patients with locally-advanced, unresectable (Stage III) NSCLC who had not progressed following standard platinum-based chemotherapy concurrent with radiation therapy. 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, the second for Imfinzi.
