Applications under review in EU, China, other countries (Il Sole 24 Ore Radiocor) - London, 16 Aug - Anglo-Swedish drug company AstraZeneca said that the US Food and Drug Administration approved Imfinzi for the treatment of resectable non-small cell lung cancer before and after surgery after the AEGEAN Phase III trial results that showed Imfinzi-based regimen reduced the risk of recurrence, progression or death by 32% compared with neoadjuvant chemotherapy alone.

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.

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.

Imfinzi was generally well tolerated, and no new safety signals were observed in the neoadjuvant and adjuvant settings. Further, adding Imfinzi to neoadjuvant chemotherapy was consistent with the known profile for this combination and did not compromise patients' ability to complete surgery versus chemotherapy alone.

Imfinzi is also approved in the UK, Switzerland and Taiwan (China) in this setting based on the AEGEAN results.

Regulatory applications are also currently under review in the EU, China and several other countries in this indication.

Imfinzi is the only approved immunotherapy and the global standard of care in the curative-intent setting of unresectable, Stage III NSCLC in patients whose disease has not progressed after chemoradiotherapy based on the PACIFIC Phase III trial.

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(RADIOCOR) 16-08-24 11:40:57 (0207) 5 NNNN