British drug major AstraZeneca Plc (AZN,AZN.L) announced Monday that the US Food and Drug Administration has accepted a supplemental New Drug Application or sNDA for the use of Tagrisso (osimertinib) in 1st-line EGFR-mutated non-small cell lung cancer.
The FDA has granted Tagrisso Priority Review status and previously granted Breakthrough Therapy Designation in the 1st-line treatment of patients with metastatic EGFR mutation-positive (EGFRm) NSCLC.
The submission acceptance is based on data from the Phase III FLAURA trial, in which Tagrisso significantly improved progression-free survival compared to current 1st-line EGFR-TKIs, erlotinib or gefitinib, in previously-untreated patients with locally-advanced or metastatic EGFRm NSCLC.
TAGRISSO is approved in more than 60 countries, including the U.S., EU, Japan and China, for the treatment of advanced non-small cell lung cancer patients whose tumors have a specific epidermal growth factor receptor (EGFR) mutation (T790M) and whose disease has gotten worse after treatment with other EGFR-blocking therapy.
On September 28, the US National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology were updated to include the use of Tagrisso in the 1st-line treatment of patients with metastatic EGFRm NSCLC. The use of Tagrisso in this indication is not yet approved by the FDA.
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