The FDA has granted AstraZeneca’s lung cancer treatment Breakthrough Therapy Designation, indicating that it offers big improvement compared with current options.
A sixth AstraZeneca cancer treatment since 2014 has received a Breakthrough Therapy Designation. The candidate, Tagrisso, targets non-small cell lung cancer by inhibiting mutations in the epidermal growth factor receptor (EGFR) gene. The drug obtained positive Phase III results, and will now receive additional support during its application for marketing approval.
Lung cancer is responsible for around 25% of all cancer deaths in men and women. Current first-line treatments use EGFR tyrosine kinase inhibitors, which block tumor cell growth. But, approximately 50% of patients develop resistance to these and the cancer is free to progress.
AstraZeneca’s candidate, Tagrisso, overcomes this by irreversibly inhibiting EGFR tyrosine kinase to prevent EGFR-sensitizing and EGFR-resistance mutations, as well as the mutations that promote disease progression. During a Phase III trial, Tagrisso almost doubled the median progression-free survival of patients to 18.9 months in comparison with 10.2 months for current first-line EGFR tyrosine kinase inhibitors.
These results prompted the FDA to award the drug Breakthrough Therapy Designation, which means it will receive extra guidance from the FDA when applying for market approval. Sean Bohen, Chief Medical Officer at AstraZeneca highlighted the massive effect that the drug could have on patient survival: “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.”
The pharma giant is not alone in its targeting of EGFR to treat cancer, with IGEM Therapeutics developing IgE antibodies against the protein. Biotech veteran Transgene is chasing down AstraZeneca in the lung cancer field with its vaccine and checkpoint inhibitor combination therapy, which is poised to enter Phase II trials.
Tagrisso makes a meaningful difference to the survival of patients that may be losing hope in their fight against cancer. With its ability to add almost a year to the lives of patients, all signs point to AstraZeneca getting its candidate onto the market.
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