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FDA Approves Taxotere for the Treatment of Women with Early Stage Breast Cancer

BRIDGEWATER, N.J. -- August 19, 2004 -- Aventis announced today that the U.S. Food and Drug Administration (FDA) has approved TaxotereŽ (docetaxel) Injection Concentrate in combination with doxorubicin and cyclophosphamide (TAC regimen) for the adjuvant (post surgery) treatment of patients with operable, node-positive breast cancer. The supplemental New Drug Application (sNDA) received a Priority Review designation by the FDA, which is assigned to those applications that have the potential for providing a significant therapeutic advance. The additional indication also is under review by the European regulatory authorities.

The FDA based its decision on results from a second interim analysis from the pivotal Breast Cancer International Research Group (BCIRG) 001/TAX 316 study, which demonstrated that women with node-positive, early stage breast cancer who received a Taxotere-based chemotherapy regimen (TAC) after surgery experienced a significant 25.7% reduction in their risk of relapse (or the chance of their cancer returning) as compared to women treated with another adjuvant combination regimen of 5-fluorouracil, doxorubicin, and cyclophosphamide (FAC). Notably, with nearly 5-years of follow-up (55 months), the significant reduction in the risk of relapse of this Taxotere-based regimen was observed regardless of a woman's hormone receptor status.

Additionally, at the time of this interim analysis, based on a total of 219 deaths, overall survival was longer for TAC than FAC (hazard ratio=0.69, 2-sided 95% CI=0.53, 0.90). There will be further analysis at the time survival data mature.

"The FDA approval of Taxotere in early stage breast cancer demonstrates the continued effectiveness of this agent across various stages of breast cancer," said Frank Douglas, MD, PhD, Executive Vice President of Drug Innovation and Approval and a Member of the Board of Management at Aventis. "More importantly, the approval of Taxotere marks an important advance for women diagnosed with node-positive, early stage breast cancer, given the significant improvement in disease-free survival."

It is estimated that worldwide more than 300,000 women per year will be diagnosed with node-positive, early stage breast cancer. Most patients with early stage breast cancer (cancer localized to the breast with or without invasion of the lymph nodes under the arm) undergo surgery to remove the tumor. After surgery, most patients receive additional treatments, which may include chemotherapy to reduce the probability of tumor recurrence. Earlier diagnosis of breast cancer results in earlier treatment and may offer a better chance for cure.

"The nearly 5-year follow-up data from the study suggest that by substituting Taxotere for 5-fluorouracil in a standard chemotherapy regimen in the adjuvant setting, we now have a treatment that may be able to benefit more women with early stage breast cancer," said Dennis Slamon, MD, Chairman of the BCIRG Scientific Committee and Director of Clinical and Translational Research at UCLA's Jonsson Comprehensive Cancer Center. "With this approval, Taxotere takes a leading role in the treatment of women with node-positive, early stage breast cancer."

About the BCIRG 001 / TAX 316 Study
The primary endpoint of this multi-center study was to compare the disease-free survival after treatment with Taxotere in combination with doxorubicin (Adriamycin) and cyclophosphamide (Cytoxan), (TAC), to a standard regimen of 5-fluorouracil, doxorubicin and cyclophosphamide, (FAC). The nearly 5-year follow-up results of the study were presented at the San Antonio Breast Cancer Symposium on December 5, 2003.

The study enrolled 1,491 pre- and post-menopausal women with node-positive, early stage breast cancer from 112 sites in 20 countries between June 1997 and June 1999. Women were randomized to receive either TAC or FAC in the adjuvant setting.

Follow-up data (55 months) of women on the study did not identify unexpected safety concerns and confirmed the results already presented at the time of the first interim analysis (33 months). Specifically, the TAC regimen was associated with a higher rate of febrile neutropenia (low white blood cell count that can lead to infections) compared with FAC (24.7% versus 2.5%). However, incidence of severe infection were similar (3.9%
versus 2.2%) and there were no treatment-related deaths due to infection in the study. Patients in the study were not treated with primary prophylactic G-CSF (granulocyte colony-stimulating factor), but G-CSF was required for subsequent cycles following the first episode of febrile neutropenia and/or infection.

Other severe adverse events occurring in 5% or more of patients treated with TAC included neutropenia, nausea, stomatitis and asthenia, and with FAC included neutropenia, nausea, vomiting and asthenia.

More than 90% of patients in both treatment groups received all six cycles of treatment.

Breast Cancer
Breast cancer is the most common cancer among women other than skin cancer. It is the second-leading cause of cancer death in women after lung cancer -- and is the leading cause of cancer death among women ages 40 to 59. More than 1,000,000 new cases of breast cancer are reported worldwide annually and more than 400,000 women die each year from the disease. The risk of a woman developing breast cancer during her lifetime is approximately 11% (about one in nine of all women worldwide). In the United States alone, breast cancer this year is expected to account for 32% (215,990) of all new cancer cases among women, and approximately 40,110 women will die from the disease.

About Taxotere
Taxotere, a drug in the taxoid class of chemotherapeutic agents, inhibits cancer cell division by essentially "freezing" the cell's internal skeleton, which is comprised of microtubules. Microtubules assemble and disassemble during a cell cycle. Taxotere promotes their assembly and blocks their disassembly, thereby preventing many cancer cells from dividing and resulting in death in some cancer cells.

Taxotere is currently approved in the United States to treat patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy, and patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) in combination with cisplatin, who had not received prior chemotherapy. It also is approved for patients with unresectable locally advanced or metastatic NSCLC after failure of prior platinum-based chemotherapy. On May 19, 2004, the U.S. Food and Drug Administration granted approval of Taxotere for use in combination with prednisone as a treatment for men with androgen-independent (hormone-refractory) metastatic prostate cancer.

Among patients receiving Taxotere the most common severe adverse events were low blood cell count, fatigue, diarrhea, and mouth and throat irritation.

The most common non-severe side effects include hair loss, numbness, a tingling and/or burning sensation, dyspnea, rash, nail changes, nausea, vomiting, and muscle pain. Less common severe or potentially life threatening side effects include fluid retention, infections, and allergic reactions.


SOURCE: Aventis

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