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The FDA has approved an expanded indication for Tykerb (lapatinib) that allows it to be administered with Femara (letrozole) to treat hormone-positive and HER-2 positive advanced breast cancer in postmenopausal women for whom hormonal therapy is indicated (see story, p. 11).

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The FDA has approved the use of Rituxan (rituximab) to treat patients with treatment-naïve or refractory chronic lymphocytic leukemia. This indication covers Rituxan’s use with chemotherapy drugs fludarabine and cyclophosphamide. Rituxan is a monoclonal antibody that binds to CD20 on cancer cells.

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The FDA developed a risk-management plan with Amgen and Johnson & Johnson requiring the companies to do more to publicize the safety risks of Amgen’s Aranesp or Epogen and J&J’s Procrit, used to treat anemia in cancer patients. The companies must also register prescribing oncologists, having them document discussing the drugs’ risks with patients before use.

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The FDA will hold a public meeting on March 30 for input on regulating radiation associated with CT scans, nuclear medicine studies, and fluoroscopies, following reports of patients receiving excessive amounts of radiation and an article showing radiation from imaging studies increases cancer risk. Possible measures are to require displays indicating radiation dose, an alert system for when radiation exceeds an optimal dose, and better training for technicians.

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FDA staff reviewing the effectiveness of Pixuvri (pixantrone) for non-Hodgkin lymphoma expressed concern that Cell Therapeutics had provided insufficient evidence of the drug’s effectiveness in light of its “substantial hematologic and cardiac toxicity.” A scheduled ODAC meeting has been postponed.

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The FDA staff also questioned the effectiveness of Omapro by ChemGenex in patients with chronic myeloid leukemia who have the T315I mutation, which conveys resistance to current tyrosine kinase inhibitors. The study failed to meet accrual goals. The FDA noted no approved test exists for the T315I mutation. The agency plans to convene an ODAC panel.