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Exemestane was approved by the U.S. FDA in October 2005. The drug is commercialized under the brand name Aromasin by Pfizer and is used as an adjuvant treatment in postmenopausal women who suffer from estrogen receptor positive early-stage breast cancer. Women generally begin taking exemestane after they’ve been on tamoxifen for two to three years, then switch to exemestane for two to three years, for a total of five consecutive years of adjuvant hormonal therapy.

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The FDA’s approval of the drug was based on a double-blind, multi-center, international clinical trial that included 4,724 postmenopausal women with early-stage breast cancer, known as the Intergroup Exemestane Study (IES).

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“After a median duration of randomized therapy of 27 months and with a median duration of follow-up of 34.5 months, DFS [disease-free survival] was significantly improved in patients who switched to exemestane compared to those who continued tamoxifen,” according to the NCI. “In the hormone receptor-positive subpopulation representing about 85 percent of the trial patients, DFS was significantly improved in the exemestane arm compared to the tamoxifen arm.”

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The same study indicated that the most common side effects of the treatment include hot flashes, fatigue, joint pain, headache, insomnia, increased sweating, hypertension, and dizziness. Rarer adverse events, such as heart problems, can also occur.