AstraZeneca announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Tagrisso (osimertinib) for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).
The FDA granted the BTD based on data from the Phase III FLAURA trial of Tagrisso versus standard-of-care EGFR tyrosine kinase inhibitor (TKI) therapy in previously-untreated patients with locally-advanced or metastatic EGFR mutation-positive NSCLC. The trail showed that the median progression-free survival was nearly double at 18.9 months for Tagrisso compared with 10.2 months for current first-line EGFR TKIs (erlotinib or gefitinib). Developments were seen in all pre-specified subgroups, including patients with and without brain metastases. Tagrisso was well tolerated with a safety profile consistent with previous experience.
Tagrisso (osimertinib) is a third-generation, irreversible EGFR TKI designed to inhibit both EGFR-sensitising and EGFR T790M-resistance mutations, with clinical activity against central nervous system (CNS) metastases.
“The Breakthrough Therapy Designation acknowledges not only Tagrisso’s potential as a first-line standard of care in advanced EGFR mutation-positive NSCLC, but also the significant need for improved clinical outcomes in this disease,” said Sean Bohen, executive vice president, global medicines development and chief medical officer at AstraZeneca. “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 US National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology were updated on September twenty-eighth to include the use of Tagrisso in the first-line treatment of patients with locally advanced or metastatic EGFR mutation-positive NSCLC. However, the use of Tagrisso for the first-line treatment of patients with locally advanced or metastatic EGFR mutation-positive NSCLC is not yet FDA approved. Currently, Tagrisso is approved in more than fifty countries, including the US, EU, Japan, and China, as a second-line treatment for patients with advanced NSCLC who advance following treatment with an EGFR TKI due to the EGFR T790M resistance mutation.
The FDA has now given six BTD’s to AstraZeneca for oncology medicine since 2014. Breakthrough therapy designation is designed to accelerate the development and regulatory review of new medicines that are intended to treat a serious condition and that have shown encouraging early clinical results, which demonstrate substantial improvement on a clinically-significant endpoint over available medicines and when there is a significant unmet medical need.
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines, primarily for the treatment of diseases in the areas of oncology, cardiovascular and metabolic diseases and respiratory.