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Centocor Ortho Biotech Receives FDA Complete Response Letter Regarding DOXIL(R) for the Treatment of Advanced Breast Cancer

ents with a history of cardiovascular disease, or if the results of cardiac monitoring indicate possible cardiac injury, the benefit of therapy must be weighed against the risk of myocardial injury
  • In the randomized multiple myeloma study, 25 patients (8%) in the VELCADE for Injection arm and 42 patients (13%) in the VELCADE plus DOXIL arm experienced left ventricular ejection fraction decrease (defined as absolute decrease greater than or equal to 15% over baseline or a greater than or equal to 5% decrease below institutional lower limit of normal)
  • Myelosuppression may occur; frequently monitor complete blood count (including platelet count), at least prior to each dose of DOXIL
    • In patients with recurrent ovarian cancer or AIDS-related Kaposi's sarcoma, hematologic toxicity (based on platelet count or absolute neutrophil count) may require dose reduction or delay in administration of DOXIL
    • In patients with multiple myeloma, hematologic toxicity (based on platelet count, absolute neutrophil count, hemoglobin level, or neutropenia with fever) may require dose reduction, delay in administration, or suspension of DOXIL and/or VELCADE
    • Persistent severe myelosuppression may result in superinfection, neutropenic fever, or hemorrhage
    • Sepsis occurring during neutropenia has resulted in discontinuation of treatment and in rare cases of death
  • DOXIL may potentiate the toxicity of other anticancer therapies, especially hematologic toxicities, when used in combination with other therapies that suppress bone marrow
  • Hand-foot syndrome (HFS) may occur during therapy with DOXIL
    • Based on HFS toxicity grade, dose reduction, or delay in administration, or discontinuation of DOXIL may be required
    • HFS was generally observed after 2 to 3 cycles of treatment, but may occu

    SOURCE Centocor Ortho Biotech Products, L.P.
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