HQ Team
April 4, 2025: AstraZeneca’s combination drug for the treatment of adults with resectable non-small cell lung cancer has got approval from the European Union.
Imfinzi is used in combination with chemotherapy in patients with a high risk of recurrence, provided the tumour cells do not harbour any mutations in the epidermal growth factor receptor (EGFR) gene, indicating that the tumour is not likely to respond to EGFR-targeted therapies.
In the treatment process, patients are treated with Imfinzi in combination with chemotherapy before surgery and as monotherapy after surgery. The goal is to lower the chance of cancer coming back.
The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on results from the end-stage trial.
Results from an interim analysis of event-free survival showed a “statistically significant and clinically meaningful 32% reduction in the risk of recurrence,” progression events or death versus chemotherapy alone, according to an AstraZeneca statement.
Cancer recurrence
Each year in Europe, there are more than 450,000 people diagnosed with lung cancer. Around 25-30% of all patients with non-small cell lung cancer, the most common form of lung cancer, are diagnosed at an early stage to have surgery.
A majority of patients with resectable disease will develop recurrence and only 36-46% of patients with stage II disease will survive for five years.
Professor Martin Reck, Head of the Department of Thoracic Oncology at the Lung Clinic Grosshansdorf, Germany, and an investigator in the trial, said Imfinzi “meaningfully improved outcomes…significantly extending the time patients lived without their cancer returning.”
Imfinzi is approved in the US, China and several other countries. Regulatory applications are currently under review in Japan.
Lung cancer is often diagnosed at advanced stages when treatment options are limited. Screening high-risk individuals has the potential to allow early detection and to dramatically improve survival rates, according to the WHO.
