EMA Approves AstraZeneca’s Lung Cancer Drug

European regulators have approved a lung cancer drug from UK-Swedish drug maker AstraZeneca. Tagrisso was the first new drug to win accelerated approval by the European Medicines Agency and follows the go-head granted by the US Food and Drug Administration last November.

Tagrisso is also the first drug to target certain lung cancer patients whose tumors have developed a mutation called T790M, which is resistant to treatment. Nearly two-thirds of patients treated with the approved epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) develop this mutation. Options to treat these patients are limited as a result.

The drug’s approval is based on two Phase II studies which showed that tumors shrank in 66% of cases. AstraZeneca is continuing to run phase III clinical trials to compile more data on Tagrisso’s safety and effectiveness.

Sean Bohen, executive vice president, global medicines development and chief medical officer at AstraZeneca, said the fast-track approval reflected the importance of Tagrisso for meeting the needs of lung cancer patients with the T790M mutation.

Matthew Peters, chair of the Global Lung Cancer Coalition, added that the drug offers a more accurate and efficient approach to lung cancer care, as well as greater prospects for durable treatment outcomes.

Lung cancer accounts for about one-third of all cancer deaths and kills more than 260,000 people every year in Europe. AstraZeneca believes Tagrisso could generate as much as $3 billion a year in sales.