The US Food and Drug Administration has granted full approval to Johnson & Johnson’s Doxil (doxorubicin) in the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy.

Doxil originally won accelerated approval back in June 1999 to treat refractory ovarian cancer, based on tumour response rates from three Phase II studies. Under the terms of the accelerated approval, J&J completed a Phase III trial to formally demonstrate the drug’s clinical benefit in patients with relapsed ovarian cancer. These data, which showed that patients receiving Doxil had improved survival versus, slower time to disease progression and better tumour response rate those receiving GlaxoSmithKline’s cancer drug Hycamtin (topotecan), were filed with the agency in March last year and are now reflected on the product label.

The firm notes that ovarian cancer is the most deadly form of gynecologic cancer, with an estimated 22,220 American women expected to be diagnosed with ovarian cancer in 2005 – more than 16,000 of whom will die from the disease. The Ovarian Cancer National Alliance reports that approximately 50% of women diagnosed with ovarian cancer die from it within five years. However, nearly 75% of ovarian cancer cases are diagnosed in later stages when the disease is more difficult to treat and the chance of five-year survival is only about 25%.