FDA Grants Approval for Gemzar® in combination with Taxol® as First-line cancer

FDA Grants Approval for Gemzar® in combination with Taxol® as First-line Treatment for Metastatic Breast Cancer

The U.S. 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.

According to the World Health Organization, more than 1 million cases of breast cancer will be diagnosed in 2004. Breast cancer is the most common malignancy in women. In the U.S., breast cancer is one of the leading causes of cancer deaths, with 40,580 estimated deaths in 2004. About 40 percent of breast cancer patients develop metastatic breast cancer after receiving treatment during the primary breast cancer phase and the average survival time for patients after diagnosis of metastatic disease is 18 to 30 months.

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 an improvement in time to disease progression and response rate compared to Taxol® alone. The time to disease progression data (5.2 months vs. 2.9 months, 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.

“In a disease that is marked by high recurrence rates, this added benefit is welcome news to patients and physicians,” said Paolo Paoletti, M.D. vice president of oncology clinical research at Eli Lilly and Company (NYSE: LLY). “The Gemzar®/Taxo®l combination is one of the few combinations to surpass the single-agent efficacy of Taxol®, and to do so with manageable side effects.”

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.

Gemzar: In the U.S., Gemzar® was approved for the treatment of locally advanced or metastatic pancreas cancer in 1996 and, in combination with Platinol®, for the treatment of locally advanced or metastatic non-small cell lung cancer in 1998. Gemzar® is approved in more than 90 countries and is the worldwide standard of care for pancreatic cancer and in many parts of the world for non-small cell lung, bladder and breast cancers. Gemzar® is a nucleoside analogue that interferes with the process of DNA production; thereby preventing cancer cells from replicating and thus slows or stops tumor growth.

Reference: Eli Lilly Company. Press Release, INDIANAPOLIS, May 19, 2004, www.lilly.com.

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