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Centocor Ortho Biotech Receives FDA Complete Response Letter Regarding DOXIL(R) for the Treatment of Advanced Breast Cancer
Date:9/10/2009

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  • The reaction was mild in most patients, resolving in 1 to 2 weeks
  • The reaction can be severe and debilitating in some patients, resulting in discontinuation of therapy
  • DOXIL is an irritant, not a vesicant; use precautions to avoid extravasation
  • DOXIL can cause fetal harm when used during pregnancy
  • Recall reaction has occurred with DOXIL administration after radiotherapy
  • DOXIL may interact with drugs known to interact with the conventional formulation of doxorubicin HCl
  • In patients with recurrent ovarian cancer, the most common all-grade adverse reactions (ARs) >20% (DOXIL vs topotecan, respectively) included: asthenia (40% vs 51%), fever (21% vs 31%), nausea (46% vs 63%), stomatitis (41% vs 15%), vomiting (33% vs 44%), diarrhea (21% vs 35%), anorexia (20% vs 22%), dyspnea (15% vs 23%), HFS (51% vs 1%), and rash (29% vs 12%)
    • In addition, 19% vs 52.3% reported alopecia (all grades)
    • Grade 3/4 hematologic ARs reported in >5% (DOXIL vs topotecan, respectively) were neutropenia (12% vs 76%) and anemia (6% vs 29%)
  • In patients with multiple myeloma, the most common all-grade ARs >20% (VELCADE plus DOXIL vs VELCADE, respectively) included: neutropenia (36% vs 22%), thrombocytopenia (33% vs 28%), anemia (25% vs 21%), fatigue (36% vs 28%), pyrexia (31% vs 22%), asthenia (22% vs 18%), nausea (48% vs 40%), diarrhea (46% vs 39%), vomiting (32% vs 22%), constipation (31% vs 31%), mucositis/stomatitis (20% vs 5%), peripheral neuropathy (42% vs 45%), neuralgia (17% vs 20%), and rash (22% vs 18%)
    • In addition, 19% vs <1% reported HFS
  • In patients with AIDS-related Kaposi's sarcoma, ARs reported in greater than or equal to 5% of DOXIL-treated patients were: neutropenia (ANC <1000/mm3, 46%; <500/mm
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  • SOURCE Centocor Ortho Biotech Products, L.P.
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