UPDATE 1-Roche, OSI win U.S. approval for wider Tarceva use

* First oral therapy for lung cancer maintenance

* Tarceva had 2009 sales of $1.2 billion

WASHINGTON, April 16 (Reuters) - Roche Holding AG (ROG.VX) and OSI Pharmaceuticals OSIP.O won U.S. approval on Friday to promote earlier use of the blockbuster lung cancer pill Tarceva.

The Food and Drug Administration cleared Tarceva for patients with lung cancer that remained stable after chemotherapy. The two companies co-market the drug.

"We hope this approval will help more people fight the leading cause of cancer death in the United States," Hal Barron, chief medical officer at Roche's Genentech unit said in a statement. "Tarceva is the first oral maintenance option for people with advanced NSCLC (non-small cell lung cancer) who want to continue treating their cancer before it grows or spreads again."

Tarceva, which had $1.2 billion in sales last year, already was approved for treating lung cancer that had gotten worse following at least one chemotherapy regimen.

Japan's Astellas Pharma Inc (4503.T) has made a hostile takeover bid for OSI. Astellas recently extended a $3.5 billion tender offer to April 23.

OSI receives royalties on sales of Tarceva, which is also approved for pancreatic cancer. The Melville, New York-based company reported $358.7 million in Tarceva-related revenue last year -- more than 80 percent of its total revenue -- and net income of $75.9 million.

In December, an FDA advisory panel voted 12-1 against recommending approval of the wider use for Tarceva. Panel members who were opposed said the drug's benefit was modest in the earlier setting.

Tarceva improved survival by about one month compared to a placebo when given to stable patients. But both Tarceva and another drug, docetaxel, have been shown to boost survival of lung cancer patients by about three months when started after their disease has advanced.

The drug's generic name is erlotinib.

Tarceva will compete with Eli Lilly and Co's (LLY.N) Alimta, which already is approved for the earlier lung cancer use. (Reporting by Lisa Richwine and Deena Beasley; editing by Carol Bishopric)