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news.Following a successful phase III trial, Tibotec Therapeutics, part of the Johnson & Johnson Family of Companies, has been granted full FDA approval for its anticancer injection, Doxil, in ovarian cancer.
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Doxil (doxorubicin HCl liposome injection) is now approved for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy.
Doxil originally received accelerated approval for refractory ovarian cancer in June 1999. As a result of the full approval, the product label for Doxil has been updated to include survival, time to disease progression and tumor response rate data from a randomized phase III clinical study.
Doxil is marketed in the US by Tibotec Therapeutics and in Israel by Janssen-Cilag. Schering-Plough, under a licensing agreement, has exclusive rights to market the medication as Caelyx throughout the rest of the world, excluding Japan.
J&JPRD and ALZA Corporation, both also belonging to the Johnson & Johnson Family of Companies, collaborated on the clinical development of Doxil for ovarian cancer.