FDA Approves IXEMPRA(TM) (ixabepilone), a Semi-Synthetic Analog of Epothilone B, for the Treatment of Advanced Bre... (ade 3/4: 54%) and leukopenia (Grade 3/4:...)

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FDA Approves IXEMPRA(TM) (ixabepilone), a Semi-Synthetic Analog of Epothilone B, for the Treatment of Advanced Breast Cancer

Date:10/16/2007

ade 3/4: 54%) and leukopenia (Grade 3/4: 49%).

(Phase III, Combination Trial: -046) The randomized Phase III trial evaluated the efficacy and safety of IXEMPRA in combination with capecitabine in comparison with capecitabine as monotherapy. This trial included 752 patients who were previously treated with anthracyclines and taxanes, and whose tumors had demonstrated prior resistance to these therapies. Anthracycline resistance is defined as progression while on therapy or within six months in the adjuvant setting, or three months in the metastatic setting. Taxane resistance is defined as progression while on therapy or within 12 months in the adjuvant setting or four months in the metastatic setting. Evaluation of the primary endpoint demonstrated that IXEMPRA in combination with capecitabine resulted in a statistically significant improvement in progression-free survival compared to capecitabine monotherapy - median 5.7 (95% CI, 4.8-6.7) vs. 4.1 months (95% CI, 3.1-4.3); P<0.0001, Hazard ratio=0.69 (95% CI, 0.58-0.83).

Treatment-related non-hematological adverse events (greater than or equal to 20%) reported in patients treated with IXEMPRA in combination with capecitabine included: peripheral sensory neuropathy 65% (Grade 3/4: 21%), palmar-plantar erythrodysesthesia (hand-foot) syndrome 64% (Grade 3/4: 18%), fatigue/asthenia 60% (Grade 3/4: 16%), nausea 53% (Grade 3/4: 3%), diarrhea 44% (Grade 3/4: 6%), vomiting 39% (Grade 3/4: 4%), myalgia/arthralgia 39% (Grade 3/4: 8%), anorexia 34% (Grade 3/4: 3%), stomatitis/mucositis 31% (Grade 3/4: 4%), alopecia 31% (Grade 3/4: 0%), abdominal pain 24% (Grade 3/4: 2%), nail disorder 24% (Grade 3/4: 2%), musculoskeletal pain 23% (Grade 3/4: 2%), and constipation 22% (Grade 3/4: 0%). Treatment-related hematological adverse events (greater than or equal to 20%) reported in patients treated with IXEMPRA in combination with capecitabine included: neutropenia (Grade 3/4: 68%) and leukopenia (Grade 3/4: 57%).

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FDA Approves IXEMPRA(TM) (ixabepilone), a Semi-Synthetic Analog of Epothilone B, for the Treatment of Advanced Bre...(ade 3/4: 54%) and leukopenia (Grade 3/4:...)