• Full approval follows Tagrisso’s expedited Conditional Marketing Authorisation as first-in-class medicine for patients with locally-advanced or metastatic EGFR T790M mutation-positive non-small cell lung cancer
• Tagrisso is a potential new standard of care in 2nd line and subsequent therapy in this hard-to-treat form of lung cancer
• Approval is based on Phase III AURA3 data which demonstrate significant clinical superiority of Tagrisso over chemotherapy in EGFR T790M mutation-positive NSCLC patients, including those with CNS metastases

AstraZeneca has announced that the European Commission (EC) has granted full marketing authorisation for Tagrisso (osimertinib) 40mg and 80mg once-daily tablets for the treatment of adult patients with locally-advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).

The full approval for Tagrisso is based on the results of the Phase III AURA3 trial, which were presented last year. The EGFR T790M mutation can be detected with a validated test using either DNA derived from a biopsy or circulating tumour DNA (ctDNA) obtained from a plasma sample.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “The full approval of Tagrisso in the EU is further evidence of our exciting progress in transforming the science of cancer care to deliver life-changing medicines to people most in need. Having demonstrated its superiority over chemotherapy in EGFR T790M mutation-positive non-small cell lung cancer, Tagrisso has the potential to become the new standard of care for patients with this difficult-to-treat form of lung cancer.”

Data from the Phase III AURA3 trial showed that Tagrisso demonstrated statistically-significant improvements in progression-free survival (PFS) over standard platinum-based doublet chemotherapy in 419 patients with EGFR T790M-positive advanced NSCLC whose disease had progressed on or after EGFR TKI therapy. Among patients taking Tagrisso, the PFS was 10.1 months, compared to 4.4 months in the chemotherapy arm. The objective response rate (ORR) was 71% compared to 31% for chemotherapy. Among 144 patients with metastases to the central nervous system (CNS), PFS was 8.5 months versus 4.2 months.

The most common adverse reactions in the Tagrisso group were diarrhoea (41% overall; 1% Grade ≥3), rash (34% overall; 1% Grade ≥3), dry skin (23% overall; 0% Grade ≥3), paronychia (22% overall; 0% Grade ≥3), stomatitis (15% overall; 0% Grade ≥3, and pruritus (13% overall; 0% Grade ≥3). Warnings and precautions include interstitial lung disease (ILD), keratitis, left ventricular ejection fraction (LVEF) and QTc interval prolongation.

In March 2017, the US Food and Drug Administration (FDA) granted Tagrisso a conversion from accelerated to full approval. Tagrisso was also recently approved in China through the new Priority Review Pathway, which grants an accelerated review timeline for innovative therapies.