Gemcitabine receives approvals for a fifth indication

Regulatory officials in several European markets including but not limited to Germany, Sweden, Denmark, Finland, Belgium, Hungary, Portugal, and Romania, have approved Eli Lilly's Gemzar (gemitabine) in combination with carboplatin, a standard chemotherapy agent, for the treatment of recurrent epithelial ovarian cancer.

Ovarian cancer causes more deaths in Europe than any other cancer of the female reproductive tract, with approximately 20,000 new cases of ovarian cancer diagnosed annually. Ovarian cancer is particularly lethal because of the disease's vague symptoms and high recurrence rate. 90% of women with advanced ovarian cancer will experience a recurrence of the disease after initial treatment.

'This new Gemzar combination provides women prolonged time without cancer progression, and relief of cancer symptoms. When ovarian cancer progresses it is frequently associated with significant symptoms that impede daily activities,' said Dr Jacobus Pfisterer, University of Kiel, department of Gynecology and principal investigator of the registration trial. 'Physicians must aggressively address recurrent disease with effective treatment that allows the patient to maintain everyday activities. To return to a state of normalcy is quite meaningful for a woman battling ovarian cancer.'

'We are pleased that Gemzar can now be used to treat women with recurrent ovarian cancer. The consistent clinical efficacy and generally manageable side effects Gemzar provides across tumor types can now be expanded to a patient population that has seen few advances in therapy in the last decade,' said Dr Paolo Paoletti, vice president of oncology clinical research at Lilly. 'With the aggressive nature of this disease, it is increasingly important to offer new innovative therapeutic options.'