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US FDA grants full approval to DOXIL(R) following submission of phase III data

topotecan HCl. The primary endpoint, time to disease progression after starting therapy, was comparable for the two treatment groups. The median time to disease progression was 4.1 months for the DOXIL group and 4.2 months for the topotecan HCl group; the p value, a statistical measurement, was 0.617. The overall median survival was 14.4 months for patients treated with DOXIL and 13.7 months for patients treated with topotecan HCl; the p value was 0.05. The p value was not adjusted for multiple comparisons. The overall tumor response rate for DOXIL-treated patients was 19.7 percent and 17 percent for topotecan-treated patients. The Phase III data were published in the September 2001 issue of the Journal of Clinical Oncology and in the October 2004 issue of the journal Gynecologic Oncology.

DOXIL is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy.

Myocardial damage may lead to congestive heart failure and may be encountered as the total cumulative dose of doxorubicin HCl approaches 550 mg/m2. The use of DOXIL may lead to cardiotoxicity. DOXIL should be administered to patients with a history of cardiovascular disease only when the benefit outweighs the risk. Acute infusion-associated reactions have occurred in up to 10 percent of patients treated with DOXIL. Serious and sometimes life-threatening or fatal allergic/anaphylactoid-like infusion reactions have been reported. Medications to treat such reactions, as well as emergency equipment, should be available for immediate use. Severe myelosuppression may occur. Dosage should be reduced in patients with impaired hepatic function. Accidental substitution of DOXIL for doxorubicin HCl has resulted in severe side effects. DO NOT SUBSTITUTE. The use of DOXIL should be limited to physicians experienced in the use of cancer chemotherapeutic agents.

In clinical studies in recurrent ovarian c
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7-Feb-2005


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