FDA grants full approval to Doxil following submission of Phase III data

FDA grants full approval to Doxil following submission of Phase III data

BRIDGEWATER, N.J., February 7, 2005 -- The FDA has granted full approval to Doxil (doxorubicin HCl liposome Injection) 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.
 
Under accelerated approval, Doxil was indicated for the treatment of metastatic ovarian cancer in patients with disease that was refractory to both paclitaxel- and platinum-based chemotherapy regimens. This approval was based on tumor response rates from three Phase II studies. According to the terms of the accelerated approval, Johnson & Johnson Pharmaceutical Research & Development completed a randomized Phase III clinical study to formally demonstrate the drug's clinical benefit in patients with relapsed ovarian cancer. In March 2004, J&JPRD submitted a supplemental new drug application (sNDA) based on data from the Phase III study.

Doxil is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. For more information about Doxil and to see the full U.S. prescribing information, visit www.Doxil.com

Source: Johnson & Johnson Pharmaceutical Services

Posted: February 2005


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