AstraZeneca wins EU approval for lung cancer drug Tagrisso

AstraZeneca has won European regulatory approval to market its Tagrisso-branded tablets for the treatment of adult patients with certain forms of lung cancer.

Tagrisso, which becomes the first new medicine to be approved under the European Commission's expedited process, will be able to be given in 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).

"Osimertinib defines a new generation of targeted EGFR-TKI treatments, and the European Commission's expedited approval reflects the importance of this innovative medicine for addressing the needs of patients with lung cancer who have the T790M mutation," said Sean Bohen, AZN's chief medical officer, said.

"We are now building on our understanding of the clinical activity of osimertinib to explore its full potential in patients with EGFRm lung cancer in multiple treatment settings."

In a recent note, Barclays said oncology was a key growth driver for AstraZeneca, driving 80% of its forecasts for incremental revenue growth to 2025.

"Oncology is fundamental to AZN’s specialist focus shift – speciality moves from 18% to 44% of group revenues in 2025, with over two-thirds of the transition driven by the growth of the oncology business. The launch of Tagrisso for lung cancer and phase 3 data for Lynparza in breast cancer are key AZN focuses in 2016," analysts wrote.

Asta noted that patients who have the EGFRm form of NSCLC, which occurs in 10-15% of NSCLC patients in Europe and 30-40% of NSCLC patients in Asia, are particularly sensitive to treatment with currently available EGFR tyrosine kinase inhibitors, which block the cell signalling pathways that drive the growth of tumour cells.

However, tumours almost always develop resistance to treatment, leading to disease progression.

But studies of Tagrisso, which was known as AZD9291 or osimertinib, has show an objective response rate of 66% and median progression-free survival of 9.7 months.

JPMorgan on Monday estimated Tagrisso, which was approved in the US in November, could reap $5m in the fourth quarter, from mainly stocking, potentially some off-label 1st-line use.