Tagrisso Gets the Attention of the FDA

James Radke

AstraZeneca wants its second-line orphan drug therapy for metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) to be the rare cancer’s first-line therapy.

Today, AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Tagrisso (osimertinib) as a first-line treatment of patients with metastatic EGFR+  NSCLC.
The Breakthrough Therapy Designation means the FDA has determined, based on clinical data provided, that the drug may offer substantial treatment advantages over existing options. The Breakthrough status means the drug will be given priority review when its drug application is accepted by the FDA for examination (i.e., the review process will take 6 months instead of 10 months).

NSLCL is not a rare cancer, but a subset of patients who have EGRF+ NSLCL are considered rare. In 2015, Tagrisso was granted accelerated approval as second-line therapy in patients with metastatic EGRF+ NSLCL. In March 2017, the drug was given full approval based on data from the randomized, Phase 3 AURA3 trial showing that it was more effective than standard chemotherapy as a second-line therapy.

A new Phase 3 study comparing Tagrisso to standard of care as first-line therapy in patients with locally advanced or metastatic EGRF+ NSCLC also showed the patients taking receiving the therapy fared better. The data, presented at the European Society of Medical Oncology (ESMO) 2017 Congress in September, concluded median progression-free survival (PFS) was 18.9 months in the Tagrisso-treated group compared to 10.2 months in the control group. That data was instrumental in the FDA’s decision to give the drug a Breakthrough Status.

Per AstraZeneca: Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “The Breakthrough Designation acknowledges not only Tagrisso’s potential as a 1st-line standard of care in advanced EGFR mutation-positive NSCLC, but also the significant need for improved clinical outcomes in this disease. 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.”

Adding to the positive news to accelerate the use of Tagrisso for EGRF+ NSCLC patients, the U.S. NCCN Clinical Practice Guidelines in Oncology were updated in September to include the use of Tagrisso in the first-line treatment options for patients with locally-advanced or metastatic EGFR+ NSCLC even though the drug is yet to be FDA approved for this indication.

Tagrisso (osimertinib) is an irreversible EGFR tyrosine kinase inhibitor (TKI) designed to inhibit both EGFR sensitizing and EGFR T790M resistance mutations.

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