FDA approves Pfizer’s adjuvant breast cancer treatment

The approval was based on the intergroup exemestane study (IES) which showed that patients who switched to Aromasin after 2-3 years of tamoxifen, for a combined total of five years of therapy, had 31% more protection from cancer recurrence than those who remained on five years of tamoxifen therapy.

The study established the superiority of switching to Aromasin rather than remaining on tamoxifen. Following publication of the results, the American Society of Clinical Oncologists and the US National Comprehensive Cancer Network updated their guidelines to support the use of a new switch regimen using Aromasin adjuvant treatment.

“Pfizer is pleased to announce this treatment advance,” said Dr Joseph Feczko, Pfizer’s chief medical officer. “This new indication for Aromasin provides women with a new treatment regimen that can significantly improve their chances of remaining breast cancer-free.”

In September, Pfizer received approval for adjuvant treatment in the European Union. Aromasin was approved in the US late in 1999 for the treatment of advanced breast cancer in postmenopausal women whose tumors have stopped responding to tamoxifen. It also is approved for use in Europe, Japan, and South America.