(Adds detail on trial, drug, executive comment and background)
Dec 21 (Reuters) - AstraZeneca Plc said on Monday that the U.S. drug regulator had approved Tagrisso, the British drugmaker’s top selling treatment for another type of lung cancer when diagnosed at an early stage, pushing its potential sales higher.
The lung cancer drug has now been approved in the United States for adjuvant treatment of adults diagnosed early enough for the tumour to be surgically removed, and who have a mutation of the EGFR gene, AstraZeneca said.
The approval by the U.S. Food and Drug Administration was based on late-stage results from the ADAURA trial, which showed that Tagrisso cut the risk of the tumour growing back in patients or death by 80%, the company said.
“This approval dispels the notion that treatment is over after surgery and chemotherapy ... We remain committed to treating cancer patients earlier, when they may still have a chance of being cured,” said Dave Fredrickson, executive vice-president of AstraZeneca’s Oncology business unit.
Tagrisso brought in $3.17 billion in sales in the first nine months of the year, financial results in November showed, and analysts had predicted additional sales potential for the drug between $1 billion and $3 billion from the ADAURA trial.
The EGFR mutation is found in about a quarter of global lung cancer cases, and older generation of EGFR inhibitors include Roche’s Tarceva and AstraZeneca’s own Iressa. (Reporting by Pushkala Aripaka in Bengaluru; Editing by Aditya Soni and Rashmi Aich)