FDA approves AstraZeneca’s Imfinzi in combination with chemotherapy
AstraZeneca’s Imfinzi (durvalumab) in combination with chemotherapy has been approved by the Food and Drug Administration for the treatment of adult patients with resectable early-stage (IIA-IIIB) non-small cell lung cancer and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements.
In this regimen, patients are treated with Imfinzi in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery, the company shared.
Each year, there are an estimated 2.4 million people diagnosed with lung cancer globally, with approximately 235,000 new diagnoses expected in the US in 2024. Around 25-30% of all patients with NSCLC, the most common form of lung cancer, are diagnosed early enough to have surgery with curative intent.
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However, the majority of patients with resectable disease will develop recurrence and only 36-46% of patients with Stage II disease will survive for five years. This decreases to 24% for patients with Stage IIIA disease and 9% for patients with Stage IIIB disease, reflecting a high unmet medical need, the company said.
John Heymach, professor and chair thoracic/head and neck medical oncology at The University of Texas MD Anderson Cancer Center in Houston, Texas, said, “This approval brings an important new treatment option that should become a backbone combination approach for patients with resectable non-small cell lung cancer, who have historically faced high rates of recurrence even after chemotherapy and surgery. When added both before and after surgery, durvalumab delivered a significant and meaningful improvement in outcomes in this curative-intent setting.”
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Dave Fredrickson, executive vice president of the oncology business unit at AstraZeneca, said, “Today’s approval of Imfinzi in resectable early-stage lung cancer builds on its strong foundation of changing clinical practice in unresectable Stage III disease. We remain committed to bringing novel approaches like AEGEAN to early lung cancer settings where cure is the goal of treatment.”