From Mesothelioma Help:
After continued good news with results in the treatment of lung cancer patients with Tagrisso, an anti-cancer drug, the U.S. Food and Drug Administration announced approval for the drug for lung cancer patients with the EGFR T790M mutation. In April, the European Commission granted full marketing authorization for the drug. Mesothelioma patients around the world stand to benefit from these approvals.
In November 2015, the FDA granted accelerated approval for Tagrisso based on an overall response rate of nearly 60% in 411 patients in clinical trials. Tagrisso is the first and only approved medicine in the US indicated for non-small cell lung cancer patients who have tested positive for the EGFR T790M mutation.
The full approval, granted on March 17, was based on the “statistically-significant improvements” for patients in the AURA3 trial with metastatic EGFR T790M mutation-positive NSCLC who had progressive disease following first-line EGFR TKI therapy. In the trial, patients who received Tagrisso achieved a median progression-free survival of 10.1 months compared to 4.4 months in those patients who received a chemotherapy regimen.
“The FDA’s full approval reinforces the potential of Tagrisso to become the standard of care for patients with metastatic EGFR T790M mutation-positive non-small cell lung cancer whose disease has progressed on or after first-generation EGFR-TKI therapy,” said Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, according to a March 31 press release from Astra Zeneca.