Chinese drug approval boosts AstraZeneca's lung cancer hopes

LONDON (Reuters) - AstraZeneca has won approval for its lung cancer pill Tagrisso in China, a key market for the potential blockbuster medicine.

A sign is seen at an AstraZeneca site in Macclesfield, central England May 19, 2014. REUTERS/Phil Noble/File Photo

Tagrisso is designed to help cancer patients with certain genetic mutations that are very common in China and the regulatory green light boosts the British drugmaker’s prospects in a key therapy area.

Lung cancer is a vital component of AstraZeneca’s ambitious sales targets, set in 2014 in response to a takeover attempt by Pfizer, with Tagrisso forecast to contribute $3 billion.

At the time, many analysts viewed the Tagrisso goal as unrealistic. Yet consensus forecasts have now risen to $2.8 billion for 2022, according to Thomson Reuters data, helped by its strong launch and the failure of some rival products.

Tagrisso sales last year totaled $423 million.

China is potentially the biggest market for the drug because 30 to 40 percent of Asian patients with non-small cell lung cancer have epidermal growth factor receptor mutated tumors that are receptive to Tagrisso, a far higher rate than in the West.

AstraZeneca’s head of drug development, Sean Bohen, said in a statement on Monday announcing the drug’s approval that China represented a “significant opportunity”.

Tagrisso is the first drug approved under the China Food and Drug Administration’s priority review pathway, which offers a fast track to market for an innovative medicines.

The once-daily pill is currently used as a second-line therapy, after patients have tried older drugs like Roche’s Tarceva and AstraZeneca’s own Iressa, although a clinical trial this year could prove its benefit in first-line use.

Beyond Tagrisso, investors are heavily focused on prospects for another clinical study testing a combination of two drugs in the hot area of immunotherapy, where AstraZeneca is chasing rivals such as Merck , Bristol-Myers Squibb and Roche.

Reporting by Ben Hirschler; editing by Susan Thomas