FDA Advisors Recommend Ellence For Breast Cancer Treatment
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FDA Advisors Recommend Ellence For Breast Cancer Treatment

BRIDGEWATER, NJ -- June 8, 1999 -- The United States Food and Drug Administration’s oncologic drugs advisory committee has voted to recommend that Pharmacia & Upjohn’s anti-cancer agent Ellence(TM) (epirubicin hydrochloride injection) be approved as a component of adjuvant therapy in patients with evidence of axillary nodal tumour involvement (cancer that has spread to the lymph nodes under the arm) following resection of primary breast cancer.

Adjuvant therapy, a mainstay of treatment for early breast cancer, is drug therapy following surgery to destroy any remaining cancer cells. Ellence is being considered for approval based on studies that suggest its use as a component of adjuvant chemotherapy improves overall survival and reduces the risk of cancer recurrence in women with early breast cancer compared to CMF (cyclophosphamide, methotrexate, fluorouracil), a current standard therapy

As the anthracycline of choice for the past 15 years, Ellence (marketed as Farmorubicin(R) outside the U.S.) is currently used in more than 80 countries to treat a variety of cancers, including breast cancer. As with other chemotherapies, side effects associated with Ellence are generally predictable and manageable and include hair loss, nausea, vomiting and a low white blood cell count.

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