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U.S. Department of Health and Human Services

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Doxorubicin HCl

On May 17, 2007, the U.S. Food and Drug Administration granted approval to doxorubicin HCl liposome injection (Doxil, Alza Corporation) for use in combination with bortezomib in patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy.

Efficacy and safety were demonstrated in a randomized, multi-center, international study comparing the combination of Doxil plus bortezomib versus bortezomib alone in patients with multiple myeloma who have not previously received bortezomib and had received at least one prior therapy.  Doxil, 30 mg/m2, was administered as a one-hour intravenous infusion on day 4 following bortezomib, 1.3 mg/m2, administered on days 1, 4, 8 and 11 in both treatment arms every twenty-one days.  Data were evaluated from 646 randomized patients.  The primary endpoint of time-to-progression (TTP-defined as time from randomization to progression or to death due to progression) was evaluated in a pre-specified interim analysis.  Median TTP was 9.3 months in the combination arm compared to 6.5 months with bortezomib alone (HR=0.55; 95% CI [0.43, 0.71]; p < 0.0001).  Survival data are immature at this time.

Safety data were evaluated from 636 treated patients (318 in each treatment arm).  Grade 3/4 reactions reported in greater than or equal to 10% of patients and in a greater proportion of patients treated with the combination of Doxil and bortezomib included neutropenia and thrombocytopenia.  Additional all-grade reactions reported in greater frequency with the combination arm included anemia, fatigue, pyrexia, nausea, vomiting, diarrhea, mucositis/stomatitis and hand foot syndrome.

The incidence of heart failure events was similar in the two treatment arms (3% in both groups).  Left ventricular ejection fraction decreases were observed in 13% of patients in the combination arm and in 8% of patients treated with bortezomib alone.

The initial rate of infusion of Doxil should be 1 mg/min to help minimize the risk of infusion reactions.

Full prescribing information including clinical trial information, safety, dosing, drug-drug interactions and contraindications is available at Drugs @FDA.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting Program via an online form,  by faxing (1-800-FDA-0178) or mailing the postage-paid Form 3500 available at MedWatch, or by telephone (1-800-FDA-1088).

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Created May 18, 2007