AstraZeneca’s Shares Gain as Imfinzi Given Priority Review from FDA

AstraZeneca's share price (LON: AZN) is moving on up this morning, gaining 0.58% as the firm announced that the U.S. Food and Drug Administration (FDA) has granted a priority review status for its Imfinzi (durvalumab) immunotherapy.

This development marks a significant step forward for the treatment of patients with muscle-invasive bladder cancer, indicating the urgency and potential importance of the drug in this area.

The FDA's priority review designation is awarded to medicines that could potentially offer a significant improvement in the safety or effectiveness of treating, diagnosing, or preventing serious conditions when compared to standard applications. With this designation, the regulatory agency aims to expedite the evaluation process, shortening it from the standard 10 months to six months.

AstraZeneca's application for Imfinzi is specifically focused on its use in conjunction with standard chemotherapy for the adjuvant treatment of patients with muscle-invasive bladder cancer following surgery. The decision is based on positive data from the phase III clinical trial known as DANUBE, which demonstrated a substantial clinical benefit in this patient population.

The trial results highlighted that patients treated with Imfinzi along with chemotherapy experienced improved survival rates compared to those treated with chemotherapy alone. This highlights the potential of Imfinzi to alter the therapeutic landscape for muscle-invasive bladder cancer, a disease with high recurrence rates.

Bladder cancer remains a significant health challenge globally, with an estimated 573,000 new cases and 212,000 deaths occurring annually. Muscle-invasive bladder cancer, a more aggressive form of the disease, accounts for a considerable proportion of these cases, underscoring the need for more effective treatments.

Imfinzi, a human monoclonal antibody that blocks the PD-L1 pathway, has already received approval for various indications globally, including for earlier-stage and advanced non-small cell lung cancer, biliary tract cancer, and more recently, in combination with tremelimumab for liver cancer. The drug's expansion into bladder cancer treatment forms a critical part of AstraZeneca's oncology strategy.

AstraZeneca's Executive Vice President of Oncology Research & Development, Susan Galbraith, stated that the priority review signifies a crucial advancement in addressing a significant unmet need for patients with resected, high-risk muscle-invasive bladder cancer. The company is looking forward to continuing its discussions with the FDA ahead of the expected decision date.

The FDA's decision will be eagerly awaited by the oncology community, as Imfinzi stands to provide a new treatment avenue for patients struggling with muscle-invasive bladder cancer, offering hope for improved outcomes in a difficult-to-treat cancer.