A new lung cancer pill from AstraZeneca has been approved by US regulators, in a major boost for the British drugmaker.
AZD9291, which will be sold as Tagrisso, is for advanced non-small-cell lung cancer, the most common form of lung cancer. Tagrisso targets a genetic mutation, known as T790M, that helps tumours evade current lung cancer pills. The drug will be made available to patients in the US as soon as possible and its price will be “comparable to other oral cancer therapies,” a spokeswoman said. AstraZeneca will reveal the price early next week.
Lung cancer is the leading cause of cancer death among men and women, accounting for a third of cancer deaths, more than breast, prostate and colorectal cancers combined.
The treatment, developed in Cheshire, is one of several highlighted by AstraZeneca chief executive Pascal Soriot in his defence against a £69bn takeover approach from American rival Pfizer, the maker of Viagra, last year. AstraZeneca estimates that Tagrisso could bring in sales of $3bn (£2bn) a year but analysts are more cautious, forecasting sales of $1.1bn in 2020. The company needs new blockbuster medicines to make up for sales losses on older drugs that are losing patent protection.
The once-daily Tagrisso tablet had a “significant effect on reducing tumour size in over half of patients who were treated,” said Richard Pazdur of the FDA’s centre for drug evaluation and research.
Its approval means AstraZeneca has taken another step forward in its ambition to bring six new cancer treatments to patients by 2020, following the recent launch of Lynparza for ovarian cancer in the US.
The approval comes just two-and-a-half years since Tagrisso was first tested on humans. It had received breakthrough status in the US and has also received accelerated assessment in the EU following its filing in the summer, as well as priority review in Japan.
