AstraZeneca reported a win and a loss in efforts to build a drug pipeline after the long-running loss of patent protection for blockbuster products.
Last week, the European Commission granted marketing authorization for Tagrisso for the 1st-line for treatment of adult patients for type of advanced non-small cell lung cancer
The approval is based on results from the Phase III FLAURA trial published in the New England Journal of Medicine.
Dave Fredrickson, executive vice president, head of the Oncology Business Unit at AstraZeneca, said: “Today’s approval is an exciting advance in bringing a potential new standard of care to patients with EGFR-mutated NSCLC in the EU. This milestone is also a step forward for our company, marking another regional approval for Tagrisso in the 1st-line setting.”
Dr. David Planchard, associate professor of medicine, head of Thoracic Group, Gustave Roussy cancer center, France said: “The FLAURA trial is changing medical practice in the 1st-line treatment of EGFR-mutated NSCLC. The progression-free survival benefit seen in the trial is unprecedented for patients with an EGFR mutation, and this benefit was consistent across all subgroups including in patients with or without central nervous system metastases. Further, the preliminary overall survival data, while not statistically significant at the time of the interim analysis, is promising, with a 37 percent reduction in the risk of death.”
The approval follows the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.
The approval follows the recent approvals of Tagrisso for the 1st-line treatment of patients with a type of lung cancer in the US, Brazil and the Russian Federation.
This week it was announced AstraZeneca and Eli Lilly and Company are discontinuing the global Phase III clinical trials of lanabecestat for the treatment of Alzheimer’s disease.
The decision is based on recommendations by an independent data monitoring. Trials have been discontinued. No safety issues emerged with the drug.
Menelas Pangalos, Ph.D., executive vice president, IMED Biotech Unit, AstraZeneca said: “We are saddened by this outcome as our researchers are working tirelessly to find a solution for the many people who are impacted by this devastating disease. We are committed to ensuring our findings can be used to inform further research in the Alzheimer’s community, given the importance of finding a treatment for this disease.”
AstraZeneca has a staff of 1,500 in Delaware, the home of its U.S. headquarters.
