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