AstraZeneca lung cancer drug Tagrisso gets FDA breakthrough therapy designation
Pharma news updates : Tagrisso (osimertinib), the AstraZeneca lung cancer drug has bagged the breakthrough therapy designation (BTD) from the US FDA for the treatment of non-small cell lung cancer (NSCLC) in a first line setting.
The BTD designation for the AstraZeneca cancer drug is specifically for treating metastatic NSCLC patients who have tested positive for mutations of the growth factor receptor (EGFR).
Tagrisso lung cancer drug, based on the results of its FLAURA phase 3 trial secured the breakthrough therapy designation from the US drug regulator.
In the phase 3 Astrazeneca lung cancer trial, Tagrisso or osimertinib was put up against EGFR tyrosine kinase inhibitor (TKI) therapy which is the standard-of-care for the disease.
3d Illustration Of Lungs in Human Body. Image courtesy of yodiyim at FreeDigitalPhotos.net.
Participating patients in the phase 3 Tagrisso clinical trial had locally-advanced or metastatic EGFR mutation-positive NSCLC who did not get any treatment for their condition in the past.
In the trial, AstraZeneca lung cancer drug osimertinib achieved 18.9 months for median progression-free survival against 10.2 months recorded by standard-of-care EGFR-TKIs erlotinib or gefitinib.
AstraZeneca revealed that Tagrisso lung cancer drug could improve the conditions of patients with and without brain metastases as well as those in all other pre-specified subgroups who were administered with it in the late stage clinical trial.
Tagrisso or osimertinib lung cancer drug is a third generation and irreversible EGFR-TKI inhibitor. It prevents EGFR sensitising and EGFR T790M resistance mutations that have activity in the patient’s central nervous system (CNS).
Sean Bohen, the Global Medicines Development Executive Vice President and Chief Medical Officer at AstraZeneca commenting on the Tagrisso lung cancer drug said: “The Breakthrough Designation acknowledges not only TAGRISSO’s potential as a 1st-line standard of care in advanced EGFR mutation-positive NSCLC, but also the significant need for improved clinical outcomes in this disease.
“The results of the FLAURA trial have the potential to redefine clinical expectations and offer new hope for patients who currently have a poor prognosis.”
As of now, Tagrisso is indicated in more than 50 countries like the US, Japan, EU member states and China as a second line of treatment for advanced NSCLC patients whose disease progressed despite treatment with an EGFR-TKI caused by the EGFR T790M resistance mutation.