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EMA body recommends expanded Tarceva label

July 22, 2011 10:07 PM UTC

EMA's CHMP recommended approval of a new indication for Tarceva erlotinib from Roche (SIX:ROG; OTCQX:RHHBY) in first-line, locally advanced or metastatic non-small cell lung cancer with EGFR activating mutations. Tarceva is already approved for first-line maintenance and second-line treatment of advanced or metastatic NSCLC irrespective of EGFR mutation status, and for pancreatic cancer.

CHMP did not back a label expansion for Cymbalta duloxetine from Eli Lilly and Co. (NYSE:LLY) to include treatment of moderate to severe chronic somatic pain in patients not taking NSAIDs regularly. The committee said the data in the application did not prove that Cymbalta would provide a relevant benefit, and noted that there was insufficient evidence that its effect could be maintained over time. CHMP also said more information was needed on the effects of Cymbalta in elderly patients. ...