HQ Team
December 23, 2024: The European Union regulators have greenlighted AstraZeneca’s drug to treat an advanced form of non-small cell lung cancer after it reduced the death rate by 84%.
Tagrisso or osimertinib was tested on patients with tumours that have a protein on the surface of some cells that control cell survival and division or epidermal growth factor receptor.
The patients also included those whose disease had not progressed after platinum-based chemoradiation therapy.
The European Commission’s approval was based on the results of an end-stage trial which showed Tagrisso “extending median progression-free survival to more than three years,” according to a company statement.
‘Positive opinion’
The nod follows a positive opinion of the Committee for Medicinal Products for Human Use.
Overall survival results remained “immature,” and the trial is continuing to assess overall survival as a secondary endpoint.
The trial enrolled 216 patients in more than 145 centres across more than 15 countries, including in the US, Europe, South America and Asia.
The approval “marks a breakthrough for patients in the EU with unresectable, EGFR-mutated non-small cell lung cancer, delivering the first targeted treatment in this setting,” said Manuel Cobo, MD, Specialist Physician of the Medical Oncology Service at the Carlos Haya University Hospital, Malaga, Spain, and investigator for the trial.
“Osimertinib reduced the risk of disease progression or death by an unprecedented 84% in the trial, setting a new benchmark for outcomes and underscoring the importance of testing for EGFR mutations upon diagnosis.”
‘New standard of care’
The drug is a new standard of care for patients who have historically experienced early progression after chemoradiation therapy,” Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said.
“Tagrisso is now the first and only EGFR inhibitor and targeted treatment approved in the EU for locally advanced, unresectable lung cancer.”
This is the fifth approval for Tagrisso based on the trial following recent approvals in the US, Switzerland, South Korea and Australia. Regulatory applications are also currently under review in China, Japan and several other countries.
Leading cause of cancer death
The drug is approved as monotherapy in more than 100 countries, including the US, EU, China and Japan.
Each year, an estimated 2.4 million people are diagnosed with lung cancer globally.
Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths.
Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% of patients diagnosed with NSCLC, the most common form of lung cancer. A majority of all NSCLC patients are diagnosed with advanced disease.
