(Reuters) – AstraZeneca’s top-selling Tagrisso drug has been approved for use in the European Union to treat patients with a type of early-stage lung cancer, the company said on Friday.
The European Commission has approved the lung cancer drug as an add-on treatment for adults diagnosed early enough for the tumour to be surgically removed, and who have a mutation of the EGFR gene, the British drugmaker said.
The approval was based on positive results from a late-stage trial called ADAURA, which showed Tagrisso cut the risk of tumour recurrence or death by 80%.
The drug is now approved to treat early-stage lung cancer in more than 50 countries, including, most recently, in the United States and China.
Tagrisso brought in sales of $1.15 billion in the first quarter, the company said in April.
The EGFR mutation is found in about a quarter of global lung cancer cases, and the older generation of EGFR inhibitors include Roche’s Tarceva and AstraZeneca’s Iressa.
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