EU clears Tagrisso for early-stage EGFR-mutated lung cancer

The European Commission (EC) has approved AstraZeneca’s (AZ) Tagrisso for the adjuvant treatment of early-stage, epidermal growth factor receptor mutated (EGFR) non-small cell lung cancer (NSCLC) following surgery.

The EC approval is based on results from the Phase III ADAURA trial, within which adjuvant treatment with Tagrisso reduced the risk of disease recurrence or death by 83% in patients with Stage II and IIIA disease, and by 80% in the overall trial population in patients with Stage IB-IIIA disease.

In addition, disease free survival (DFS) results were consistent across all prespecified groups and were observed regardless of prior adjuvant chemotherapy use.

“We know the earlier a patient’s cancer is detected and treated, the greater chance they may have of being cured, which is why this approval is significant,” said Dave Fredrickson, executive vice president, oncology business unit, AZ.

“For the first time, patients in the EU with EGFR-mutated lung cancer have a targeted, biomarker-driven treatment option available in the early stages of their disease that can help them live cancer-free longer,” he added.

Tagrisso (osimertinib), a third-generation EGFR tyrosine kinase inhibitor (TKI), is already approved to treat early-stage lung cancer in over 50 countries globally, including the US and China.

The treatment is also approved in the first-line setting for patients with locally advanced or metastatic EGFR mutated NSCLC, and for the treatment of locally advanced or metastatic EGFR T790M mutation positive NSCLC in the EU, US, Japan, China and more locations.

AZ is also currently evaluating Tagrisso in Phase III trials for the treatment of lung cancer in the stage III locally unresectable setting, in the neoadjuvant resectable setting and in combination with chemotherapy.