Data shows ELLENCE reduces risk of death and cancer recurrence in women with early breast cancer; could save thousands of lives each year.

Pharmacia & Upjohn today announced that the U.S. Food and Drug Administration (FDA) approved the anti-cancer agent ELLENCE ™ (pronounced el-LENCE) (epirubicin hydrochloride injection) as a component of adjuvant therapy following resection of early breast cancer that has spread to the lymph nodes under the arm. ELLENCE, which has been used to treat nearly one million women with breast cancer worldwide, is the first and only chemotherapy agent approved by the FDA for the adjuvant treatment of node-positive early breast cancer.

"Today's approval of ELLENCE could help save the lives of thousands of women," said Carrie Smith Cox, senior vice president, Global Business Management, Pharmacia & Upjohn. "We are excited to be able to bring this new alternative for breast cancer care to women in the United States."

ELLENCE, in combination with cyclophosphamide and fluorouracil, was approved based on mature data from a pivotal trial demonstrating that in patients with early breast cancer, it reduces the relative risk of recurrence by 24 percent and the relative risk of death by 29 percent compared to a current standard therapy, CMF (cyclophosphamide, methotrexate, fluorouracil).

With 180,000 new diagnoses every year, breast cancer is the most common form of cancer in women in the United States. It is also the second-leading cause of cancer deaths for all women in the U.S. One out of eight women in the U.S. will develop breast cancer in her lifetime.

Treatment of Breast Cancer in the United States

Adjuvant therapy, a mainstay of treatment for early breast cancer, is drug therapy following initial breast cancer surgery to destroy any remaining cancer cells. In the U.S., two commonly used adjuvant chemotherapies, CMF and AC [ADRIAMYCIN (doxorubicin hydrochloride), cyclophosphamide], have been shown to have similar survival rates.

However, ELLENCE, in combination with cyclophosphamide and fluorouracil, has been shown to offer a significant survival advantage compared to CMF, when used as adjuvant chemotherapy in early node-positive breast cancer. With roughly 75,000 women eligible for adjuvant therapy each year, a treatment regimen based on ELLENCE holds the potential for saving thousands of women with early breast cancer when used as an alternative to a CMF regimen.

Pivotal Data Supporting Approval

The approval of ELLENCE is based in part on a clinical study showing that a combination of drugs containing ELLENCE can reduce the risk of cancer recurrence and the risk of death significantly more than CMF in women with axillary-node-positive early breast cancer. The study, conducted by the National Cancer Institute of Canada Clinical Trials Group (NCIC-CTG) (http://www.ctg.queensu.ca/ctg_home.asp) and published in the Journal of Clinical Oncology (JCO) (http://www.jco.org) in August, 1998, estimated that 62 percent of women with early-stage breast cancer treated with a drug combination containing ELLENCE (cyclophosphamide, epirubicin, fluorouracil, known as CEF) will survive relapse-free for five years, as compared to 53 percent of women treated with CMF. The estimated overall survival at five years was 77 percent in the CEF arm and 70 percent in the CMF arm.

"The data demonstrate that the use of ELLENCE in women with early-stage breast cancer reduces the risk of the cancer returning and reduces the relative risk of death," said Mark Levine, MD, principal trial investigator and Professor, Department of Medicine, McMaster University, Hamilton, Ontario. "The regimen containing ELLENCE is more effective than the CMF regimen, which is commonly used in the United States."

Side effects of therapy with ELLENCE are generally predictable and manageable and are similar to those observed with other chemotherapies used in this setting. The most common side effects that may be experienced by patients during therapy include hair loss, nausea, vomiting, mouth sores, and a low white blood cell count, due to myelosuppression (bone marrow suppression) which can be severe. These side effects normally resolve at the completion of treatment. In the NCIC-CTG study, few patients (two percent) discontinued therapy due to side effects, and there were no drug-related deaths. As with other chemotherapy agents in this class, treatment with ELLENCE is associated with an increased risk of treatment-related leukemia and congestive heart failure, which were observed in clinical studies at a rate of 0.8 percent and 1.5 percent respectively.

The Pharmacia and Upjohn press release that this summary is based upon is available online at http://www.pnu.com/press_display.asp?215

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