AstraZeneca Lung Cancer Pill Gets Early U.S. Gov’t Approval

AstraZeneca Lung Cancer Pill Gets Early U.S. Gov’t ApprovalFollowing news that AstraZeneca’s lupus drug anifrolumab had passed a recent round of clinical trials, the British company’s lung cancer pill scored an important win Friday, getting early U.S. approval from government officials.

The lung cancer pill Tagrisso is specifically made for patients whose illness has become worse after being treated with other forms of therapy. It is one of a number of cancer medicines that AstraZeneca hopes to use to build up its war chest following recent patent losses on older products. Specifically, Tagrisso was cited by the company in a takeover defense against Pfizer in 2014, as AstraZeneca said that drug could potentially sell about $3 billion per year. Still, that’s interestingly more than double of what Wall Street analysts expect five years from now, as they believe the firm could earn revenue of $1.1 billion in 2020.

The early approval came from the U.S. Food and Drug Administration, who gave the thumbs-up to the once-a-day tablet to treat a specific type of patients who have advanced non-small cell lung cancer. This is an earlier approval than what analysts had forecasted, and if all goes well, AstraZeneca will make Tagrisso available as soon as possible to U.S. patients eligible to take it. Pricing, the firm said, would be “comparable” to the cost of other oral cancer therapies.

Tagrisso works in a similar way to rival drug rociletinib from Clovis Oncology that is currently in development; it attacks a genetic mutation called T790M that makes tumors impervious to present-day lung cancer pills. Since its first clinical trials, Tagrisso has gotten FDA approval in just a little over two and a half years, suggesting that the agency is approving drugs faster, while AstraZeneca is truly determined to accelerate development as much as it could. This could also mean early, accelerated approval for Clovis’ rociletinib, which is officially slated for an FDA decision by the end of March 2016.