The US Food and Drug Administration (FDA) has approved AstraZeneca’s Tagrisso (osimertinib) for the treatment of adult patient with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).

The FDA regulatory submission for Tagrisso was reviewed under the agency’s real-time oncology review (RTOR) pilot programme, which aims to make safe and effective treatments available to patients ‘a(chǎn)s early as possible’.

The approval was based on results from AZ’s ADAURA phase III trial, which evaluated Tagrisso 80mg once-daily oral tablets in the adjuvant treatment of 682 patients with stage IB, II or IIA EGFRm NSCLC following complete tumour resection and adjuvant chemotherapy.

In this trial, adjuvant treatment with Tagrisso was found to reduce the risk of disease recurrence or death by 83% in the primary endpoint of disease-free survival in patients with stage II and III disease.

In the overall population of patients with stage IB-IIIA disease, Tagrisso reduced the risk of disease recurrence or death by 80%.

At two years post-treatment initiation, 89% of patients treated with Tagrisso remained alive and disease free compared to 52% in the placebo arm after surgery – the current standard of care.

“For the first time, a targeted, biomarker-driven treatment option is available to patients in the US with early-stage EGFR-mutated lung cancer,” said Dave Fredrickson, executive vice president, oncology business unit, AZ.

“This approval dispels the notion that treatment is over after surgery and chemotherapy, as the ADAURA results show that Tagrisso can dramatically change the course of this disease. We remain committed to treating cancer patients earlier, when they may still have a chance of being cured,” he added.

Around 10-15% of people with NSCLC in the US and Europe and 30-40% in Asia have EGFRm NSCLC. This patient population is particularly sensitive to treatment with an EGFR-tyrosine kinase inhibitor (TKI), which block the cell-signalling pathways that drive the growth of tumour cells.

Tagrisso is approved for the first-line treatment of locally advanced or metastatic EGFRm NSCLC, and for the treatment of locally advanced or metastatic EGFR T790M mutation-positive NSCLC in the US, Japan, China and the EU.