Monday, April 02, 2007

Swiss reject Roche's Tarceva for pancreatic cancer | Health | Reuters



Swiss health authorities have rejected drugmaker Roche Holding AG's (ROG.VX: Quote, Profile, Research) Tarceva for use in pancreatic cancer, the company said on Thursday.

"We've actually applied for the approval and they said no," said Roche spokeswoman Martina Rupp. "It's definitely not good news for patients in Switzerland."

Rupp said Switzerland's regulatory agency, Swissmedic, had questioned the safety and efficacy of Tarceva and the approval process had not got as far as the pricing of the drug.

It is the second time Switzerland has turned down approval of Tarceva in pancreatic cancer.

Roche has already refiled its application, based on prior approvals of the drug in the European Union and United States, and is waiting on a response from Swissmedic, Rupp said.

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