The US Food and Drug Administration has granted approval of Gemzar (gemcitabine HCl), in combination with Taxol (paclitaxel), providing a new option in first-line therapy for women battling metastatic breast cancer.

The FDA's approval marks the second indication in 2004 for a Lilly Oncology drug, and for Gemzar, specifically; this is the drug's third indication in the United States.

The approval of the Gemzar/Taxol combination was granted following analysis of phase III data, which demonstrated superior treatment outcomes. Patients diagnosed with metastatic breast cancer and treated with a combination of Gemzar and Taxol experienced a significant delay than improvement in time to disease progression of their disease and response rate compared to Taxol alone. The time to disease progression data (5.2 months vs. 2.9 months, respectively) respectively; p<0.0001) were presented at the annual meeting of the American Society of Clinical Oncology (ASCO) in 2003. Survival results will be formally presented at the 2004 ASCO meeting, June 5-8 in New Orleans.

"The Gemzar/Taxol combination is one of the few combinations to surpass the single-agent efficacy of Taxol," said Paolo Paoletti, M.D. vice president of oncology clinical research at Eli Lilly and Company. "In a disease that is marked by high recurrence rates, this added benefit is welcome news to patients and physicians."

The official label on the approval states that Gemzar, in combination with paclitaxel, is approved in the United States for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.

In addition to the United States, Gemzar has been approved for this indication in 32 countries as of today.