GSK Breast Cancer Drug Tykerb Referred To European Advisory Committee For Review Following Release Of Data

Main Category: Breast Cancer
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 21 Mar 2008 - 9:00 PDT

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GlaxoSmithKline on Tuesday announced that the European Commission has referred its breast cancer drug Tyverb, sold in the U.S. as Tykerb, to the European Union's Committee for Medicinal Products for Human Use after new data found a risk of elevated liver enzymes in women taking the drug, Reuters Health reports. Tykerb is taken in combination with Roche's breast cancer treatment Xeloda to treat women with HER2-positive breast cancer, an aggressive form of the disease found in about 25% of breast cancer patients that involves extra copies of the HER2 protein.

CHMP in December 2007 conditionally approved the drug but said additional data was necessary (Reuters Health, 3/18). Final CHMP approval had been expected by March 8 (Berton, Dow Jones, 3/18). A review of clinical trials and postmarketing data found that hepatotoxicity, or elevated liver enzyme, was present in four of every 1,000 women who took the drug, according to GSK. The company in a statement said the side effect was "uncommon" and that the liver enzymes "generally returned to normal" after treatment.

According to Mike Ward, an analyst at Nomura Code, the new data likely will not change the risk-benefit profile of the drug. He said that it could add a "slight delay" to the drug's "official approval." Ward said the risk of elevated liver enzymes will be added to the drug's label but will not be a "major issue" (Reuters Health, 3/18).

GSK provided information about the new data to scientists overseeing clinical trials and health care providers in countries where the drug is approved. The company also sent a letter to physicians advising them to monitor the liver enzymes of patients taking the drug. A company spokesperson did not speculate on whether FDA will take any action as a result of the new data. FDA officials were unavailable for comment.

CHMP likely will discuss the drug at its next regulatory meeting, which is scheduled for April 21 to April 24, Dow Jones reports (Dow Jones, 3/18).

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