Drug maker AstraZeneca (AZN,AZN.L), along with its biologics research and development arm MedImmune, Tuesday announced that the US Food and Drug Administration has accepted a supplemental Biologics License Application or sBLA for Imfinzi (durvalumab).
It is for the treatment of patients with locally advanced (Stage III) unresectable non-small cell lung cancer or NSCLC whose disease has not progressed following platinum-based chemoradiation therapy. The FDA has granted Imfinzi Priority Review status.
The company said the acceptance follows FDA's Breakthrough Therapy Designation.
The sBLA submission is based on positive progression-free survival or PFS data from the Phase III PACIFIC trial. The trial continues to evaluate overall survival, its other primary endpoint.
Detailed results of the PACIFIC trial, including additional safety information, were published online in the New England Journal of Medicine.
Imfinzi (durvalumab), a human monoclonal antibody directed against PD-L1, blocks PD-L1 interaction with PD-1 and CD80 on T cells, countering the tumour's immune-evading tactics and inducing an immune response.
Imfinzi has already received accelerated approval in the US for the treatment of patients with locally advanced or metastatic urothelial carcinoma.
For comments and feedback contact: editorial@rttnews.com
Business News