AstraZeneca Leads Pipeline NewsBy
A roundup of the latest pipeline news, including from the pharmaceutical majors, featuring news from AstraZeneca.
Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, October 4, 2017 to Tuesday, October 10, 2017.
FDA Grants Breakthrough Therapy Designation for AstraZeneca’s Lung Cancer Drug Tagrisso
The US Food and Drug Administration (FDA) has granted AstraZeneca’s lung cancer drug, Tagrisso (osimertinib), breakthrough therapy designation for the first-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).
Tagrisso is currently approved in more than 50 countries, including the US, EU, Japan, and China, as second-line treatment for patients with advanced NSCLC who progress following treatment with an EGFR TKI due to the EGFR T790M resistance mutation.
EMA Accepts AstraZeneca’s MAA for Lung Cancer Drug Imfinzi
The European Medicines Agency (EMA) has accepted AstraZeneca’s marketing authorization application (MAA) for Imfinzi (durvalumab) for treating patients with locally advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy.
Imfinzi is a human monoclonal antibody directed against PD-L1 that blocks PD-L1 interaction with PD-1 and CD80 on T cells.
This is the first registrational submission for Imfinzi in the European Union. Imfinzi has received accelerated approval in the US for treating patients with locally advanced or metastatic urothelial carcinoma, who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before or after surgery.