AstraZeneca's supplemental New Drug Application (sNDA) for TAGRISSO (osimertinib) combined with chemotherapy has been accepted and granted Priority Review by the US Food and Drug Administration (FDA).
This application aims to treat adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that have the potential to offer significant improvements over existing options.
This can be demonstrated through safety or efficacy enhancements, prevention of serious conditions, or improved patient compliance. The anticipated FDA action date for their regulatory decision, known as the Prescription Drug User Fee Act date, is expected during the first quarter of 2024.
Each year, approximately 2.2 million people diagnosed with lung cancer globally Out of these, about 70% are diagnosed with advanced NSCLC. In the US and Europe, approximately 10-15% of NSCLC patients
The basis for the sNDA lies in data from the FLAURA2 Phase III trial, which was presented at the International Association for the Study of Lung Cancer (IASLC) 2023 World Conference on Lung Cancer (WCLC) in a Presidential Symposium.
In this trial, combining TAGRISSO with chemotherapy demonstrated a 38% reduction in the risk of disease progression or death Median progression-free survival (PFS) was extended by 8.8 months according to investigator assessment.
Results from blinded independent central review showed a 9.5-month extension in median PFS. The combination showed a clinically meaningful PFS benefit across various subgroups, including patients with central nervous system metastasis
The trial continues to assess overall survival (OS) as a key secondary endpoint. Regarding safety, the combination of TAGRISSO plus chemotherapy had a generally manageable profile consistent with the established profiles of the individual medicines.
Adverse event rates were higher in the combination arm due to known chemotherapy-related adverse events.
In August 2023, TAGRISSO in combination with chemotherapy received Breakthrough Therapy Designation by the FDA for the 1st-line treatment of adult patients with locally advanced or metastatic EGFRm NSCLC. TAGRISSO is already approved as monotherapy in over 100 countries, including the US, EU, China, and Japan, for various indications related to EGFRm NSCLC
