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PEAPACK, N.J. -- October 25, 1999 -- Pharmacia & Upjohn has received U.S. Food and Drug Administration (FDA) approval for Aromasin (exemestane tablets), a new treatment for advanced breast cancer in postmenopausal women.
Developed by Pharmacia & Upjohn, Aromasin is the first aromatase inactivator for use in advanced breast cancer in patients whose tumors stop responding to tamoxifen therapy.
Aromasin was generally well-tolerated in clinical trials. The most common drug-related adverse events were hot flashes, nausea, fatigue, increased sweating, and increased appetite.
Aromasin is Pharmacia & Upjohn's second new treatment for breast cancer to receive FDA approval this year. Earlier this month, the company launched Ellence (epirubicin hydrochloride injection) in the U.S. as a component of adjuvant therapy in the treatment of primary breast cancer. Ellence, which received FDA approval in September, is the first and only chemotherapy agent for treatment of early node-positive breast cancer following surgery. As with other chemotherapy agents in this class, there is an increased risk of treatment-related leukemia and congestive heart failure (incidents of 0.8 percent and 1.5 percent respectively in clinical trials).
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