AstraZeneca's Tagrisso-Chemo Combo Under FDA Priority Review For Most Common Form Of Lung Cancer

AstraZeneca Plc's AZN supplemental New Drug Application for Tagrisso (osimertinib) in combination with chemotherapy has been accepted and granted Priority Review in the U.S. for locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).

The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is anticipated during the first quarter of 2024.

Each year, an estimated 2.2 million people are diagnosed with lung cancer globally, with 80-85% of patients diagnosed with NSCLC, the most common form of lung cancer.

The sNDA is based on data from the FLAURA2 Phase 3 trial.

In the trial, Tagrisso, in combination with chemotherapy, reduced the risk of disease progression or death by 38% compared to Tagrisso monotherapy, the 1st-line global standard of care. 

By investigator assessment, the combination extended median progression-free survival (PFS) by 8.8 months versus Tagrisso alone. 

PFS results from the blinded independent central review were consistent, showing Tagrisso plus chemotherapy extended median PFS by 9.5 months.

A clinically meaningful PFS benefit was observed across all prespecified subgroups, including patients with central nervous system metastases. 

In this group, the combination reduced the risk of disease progression or death by 53% compared to Tagrisso monotherapy, extending median PFS by 11.1 months versus Tagrisso alone.

At the time of this analysis, the overall survival (OS) data were immature; however, a favorable trend was observed for Tagrisso plus chemotherapy. 

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