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Cancer Drug Information

  • Updated: 07/02/2013

FDA Approval for Doxorubicin Hydrochloride Liposome

Brand name(s): Doxil®

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

Ovarian cancer and Kaposi sarcoma after treatment with other chemotherapy

On February 4, 2013, the Food and Drug Administration (FDA) approved Lipodox (doxorubicin hydrochloride liposome injection, made by Sun Pharma Global FZE), a generic version of Doxil (doxorubicin hydrochloride liposome injection; made by Janssen Products, L.P.), for the treatment of ovarian cancer in patients whose disease has progressed or recurred after platinum-based chemotherapy and for treatment of AIDS-related Kaposi sarcoma after failure of prior systemic chemotherapy or intolerance to such therapy.

Janssen’s Doxil is currently on the FDA’s drug shortage list. For products on the shortage list, the FDA’s Office of Generic Drugs is using a priority review system to expedite the review of generic applications to help alleviate shortages. Doxil is under drug shortage because of manufacturing issues.

In February 2012, to address the shortage of Doxil, the FDA announced it would exercise enforcement discretion for temporary controlled importation of Lipodox, an alternative to Doxil produced by Sun and its authorized distributor, Caraco Pharmaceutical Laboratories Ltd. which was not then approved in the United States. Enforcement discretion was also used to release one lot of Janssen’s Doxil that was made under an unapproved manufacturing process.

For the present time, FDA intends to continue exercising enforcement discretion for importation of Lipodox, and limited supplies of Doxil are available. Once supplies of Sun’s Lipodox are sufficient to meet projected demand, FDA expects to stop exercising enforcement discretion for any unapproved doxorubicin hydrochloride liposome injection product.

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Multiple Myeloma

On May 17, 2007, the U.S. Food and Drug Administration (FDA) 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, multicenter, international study comparing the combination of doxorubicin HCl liposome plus bortezomib versus bortezomib alone in patients with multiple myeloma who have not previously received bortezomib and had received at least one prior therapy.

Doxorubicin HCl liposome, 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 percent of patients and in a greater proportion of patients treated with the combination of doxorubicin HCl liposome and bortezomib included neutropenia and thrombocytopenia. Additional all-grade reactions reported in greater frequency with the combination arm included anemia, fatigue, pyrexia (fever), nausea, vomiting, diarrhea, mucositis/stomatitis and hand-foot syndrome.

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

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

This summary was provided by Richard Pazdur, M.D., director of the FDA's Division of Oncology Drug Products.

The FDA is the division of the U.S. Department of Health and Human Services charged with ensuring the safety and effectiveness of new drugs and other products. (See "Learn How Drugs and Devices Get Approved.") The FDA's mission is to promote and protect the public health by helping safe and effective products to reach the market in a timely way, and monitoring products for continued safety after they are in use.

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