AZ's Iressa gets back in the game with first-line FDA approval in lung cancer

AstraZeneca's ($AZN) Iressa is back.

After four years off the U.S. market, the lung cancer fighter has picked up an FDA approval as a first-line lung cancer therapy, specifically for patients whose tumors test positive for certain EGFR mutations, the company said Monday.

The British drugmaker has Qiagen ($QGEN) to thank for the new nod. The diagnostics company developed a new companion test to identify EGFR mutations in tumors, which will be used to tag new NSCLC patients for eligible for Iressa.

The med--restricted in 2005 after failing to outperform placebo in a broader trial, and ultimately pulled in 2011--should be getting back in the game soon, with AZ preparing to roll it out within a week of the approval, company spokeswoman Michele Meixell told FiercePharma via email. And that launch should help buoy Iressa's sales, which declined by 4% last year to hit $623 million.

In turn, that'll help boost AstraZeneca's haul in oncology, an area it's counting on to play a key role in its future. Cancer joins categories such as respiratory on AstraZeneca's list of growth platforms--i.e., the fields where it needs to see some serious increases if it wants to hit the sky-high sales targets CEO Pascal Soriot laid out in the wake of Pfizer's ($PFE) failed hostile bid last year.

Iressa won't be entering without its competition, though. It'll go up against first-line contenders Tarceva from Roche ($RHHBY) and Gilotrif from Boehringer Ingelheim, and AZ intends to price it on par with those therapies, Meixell said.

- read AZ's release

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