21 February 2018 - - Wilmington, Delaware-based prescription medicines specialist AstraZeneca and its Gaithersburg, Maryland-based biologics research and development arm MedImmune have received US Food and Drug Administration apronval of Imfinzi (durvalumab) for the treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy, the company said.
The approval of Imfinzi is based on the positive PFS data from the Phase III PACIFIC trial in which Imfinzi demonstrated an improvement in median PFS of 11.2 months compared to placebo, representing a 48% reduction in relative risk of progression or death vs placebo in all patients, regardless of PD-L1 status.
Imfinzi can cause serious, potentially fatal adverse reactions. In patients on Imfinzi, the most common adverse reactions (greater than or equal to 20% of patients) were cough, fatigue, pneumonitis or radiation pneumonitis, upper respiratory tract infections, dyspnea, and rash.
Discontinuation after concurrent CRT due to adverse events, regardless of causality, occurred in 15% of patients receiving Imfinzi vs 10% of patients receiving placebo.
Imfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumor's immune-evading tactics and releasing the inhibition of immune responses.
MedImmune is pioneering innovative research and exploring novel pathways across oncology; respiratory, cardiovascular, and metabolic diseases; and infection and vaccines.
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas - oncology, cardiovascular, and metabolic diseases, and respiratory.
The company is also selectively active in the areas of autoimmunity, neuroscience, and infection. AstraZeneca operates in over 100 countries; its North American headquarters are located in Wilmington, Delaware.