AstraZeneca's Imfinzi Receives Priority Review From FDA for Advanced Lung Cancer

Introduction

AstraZeneca's supplemental Biologics License Application (sBLA) for the cancer drug Imfinzi (durvalumab) has been granted priority review by the U.S. Food and Drug Administration (FDA).

Positive Trial Results

The sBLA is based on positive high-level results from the Phase III ADRIATIC trial, which evaluated Imfinzi in combination with tremelimumab in patients with locally advanced or metastatic non-small cell lung cancer (LS-SCLC) who have not received prior systemic therapy.

The trial showed that Imfinzi plus tremelimumab significantly improved overall survival (OS) compared to standard chemotherapy in patients with LS-SCLC.

Priority Review

The FDA's priority review status indicates that the agency believes that Imfinzi has the potential to address an unmet medical need in the treatment of LS-SCLC.

Under priority review, the FDA aims to make a decision on the sBLA within six months, rather than the standard 10 months.

Breakthrough Therapy Designation

In addition to priority review, the FDA has also granted Breakthrough Therapy Designation to Imfinzi for the treatment of patients with LS-SCLC.

This designation is given to drugs that have shown promising early results in treating serious or life-threatening conditions.

Conclusion

The granting of priority review and Breakthrough Therapy Designation to Imfinzi is a significant step in the development of this promising new treatment for patients with LS-SCLC.

If approved, Imfinzi could provide a much-needed new option for patients with this deadly disease.