News Clippings

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ESAs—New Warnings, New Studies, and a Recall

The FDA has issued new warnings about the use of ESAs (erythropoietin stimulating agents) in patients undergoing adjuvant treatment for cancer and is requiring the drugs’ manufacturers to conduct controlled studies of the drugs’ effect on patients with metastatic disease.

BCA called for the FDA to prohibit the use of ESAs in breast cancer patients until more research is conducted into whether the drugs stimulate cancer growth. (See BCA’s February 27, 2008, letter to the to the FDA) BCA’s call was heeded in part when the FDA’s Oncologic Drug Advisory Committee urged limiting use of the drugs in the adjuvant setting, recommending that most breast cancer patients should not receive ESAs until more is known about the drugs’ safety. The committee also called for the FDA to require informed consent for cancer patients being given ESAs to treat chemotherapy-induced anemia. (For more information on the committee’s recommendation for use of these drugs, see our FDA advocacy page.)

The studies of the use of ESAs in patients with metastatic disease were triggered by evidence that such patients were more likely to die from their cancer than those not taking ESAs.

BCA has agreed to make recommendations to ESA manufacturers Amgen and Ortho-Biotech regarding the new labels on ESAs and the metastatic trial protocols.

In the meantime, a recall has been issued for some vials of Procrit, one ESA sold by Ortho-Biotech. Information about the recall is available at the Ortho-Biotech website, or call the manufacturer at 908/541-4000.

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Roche Moves to Acquire Genentech

Roche, a Swiss-based pharmaceutical company, currently owns just over half (56 percent) of the stock of Genentech, the biotech company that has developed several breast cancer drugs. In a move that surprised both the advocacy world and the business community, Roche offered in July 2008 to buy all remaining Genentech stock and take complete control of the company.

While Genentech shareholders are resisting the move because they are unhappy with the price Roche has offered, Roche will very likely succeed in purchasing the company. The implications of this takeover attempt are vast from two perspectives: the innovative nature of Genentech’s drug development effort and the ability of cancer advocacy organizations like Breast Cancer Action to continue to directly engage the biotech firm on issues related to drug pricing and effectiveness.

BCA has concerns that Genentech’s openness to conversations with activists, even those that disagree with it, may not continue if the company comes under the control of a pharmaceutical firm that is based on another continent and doesn’t seem to have much experience working with advocates.

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FDA Investigates Tykerb Liver Toxicity

As reported in the BCA Source #97, August 2007, Tykerb (lapatinib) was approved for use in metastatic breast cancer patients in March 2007. BCA objected to this approval because of the lack of survival data.

In November 2007, the FDA issued a warning letter to GlaxoSmithKline,1 the manufacturer of Tykerb, requiring the company to correct its marketing materials which, in the agency’s view, minimized the risks and overstated the benefits of the drug. In September 2008, Tykerb was added to the list of “Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS).” The concern being addressed is hepatotoxicity—liver problems. BCA has long urged the FDA to require longer-term studies of drugs, rather than swift approval. If Tykerb had been followed longer before it was approved for use, this problem might have been identified before the drug was widely marketed.

While the drug continues in use in metastatic breast cancer patients and continues to be the subject of many breast cancer trials, women should talk to their doctors about any and all side effects they experience from this drug, especially liver pain or symptoms.

1 FDA warning letter and other information about Tykerb available online at www.fda.gov/cder, search for “Tykerb.”

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Report Side Effects to the FDA

If you are experiencing problems that you think are related to cancer drugs you are taking, there is now a way for you to bring your concerns directly to the attention of the FDA, the agency whose job it is to make sure drugs are effective and safe. Go to www.fda.gov/medwatch/how.htm to report drug side effect problems online.

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