Breast Cancer: Exemestane Exemestane = drug approved by FDA as a treatment for women with breast cancer at the age of the transfer.

October 18, 2005: Source: Medscape

The FDA is following the European approval in September 2005 is now also approved the use of Aromasin exemestane = as medicine / treatment for women with breast cancer at the age of the transfer. A large phase III study (4742 women followed ten years) has shown that when this group of women just two / three years tamoxifen use and then switching to Aromasin - Exemstane that survival time is longer than with tamoxifen alone. But what is not clear to us is Compared with Femara and / or Arimidex . Because these agents also demonstrated significantly better results than tamoxifen. Here is the official FDA approval as presented at Medscape

Exemestane (Aromasin) for Adjuvant Treatment of Early Breast Cancer in postmenopausal Women

On Oct. 5, the FDA approved a new indication for exemestane (Aromasin tablets, made by Pfizer, Inc.)., Allo wing its use for the treatment of estrogen receptor-positive invasive early breast cancer after two to three years of initial adjuvant tamoxifen therapy in postmenopausal women .
The approval was based on data from the phase 3 Intergroup Exemestane Study (IES) in 4742 women, showing That use of the aromatase inhibitor was associated with a significant improvement in disease-free survival for a median of 30.6 months.
In the study, women who switched to exemestane after two or three years of tamoxifen therapy Experienced a 32% reduction in the risk of local / meta-static recurrence, contralateral breast cancer, or death compared with Those Receiving five years of tamoxifen therapy (unadjusted hazard ratio , 0.68, 95% confidence interval [CI], 0.56 - 0.82, P <.001).
The absolute benefit of exemestane in terms of disease-free survival at three years was 4.7% (95% CI, 2.6 - 6.8). Overall survival was similar Between groups.
Exemestane was linked to a higher incidence of arthralgia and diarrhea, while gynecologic symptoms, vaginal bleeding, and Muscle Cramps were more common with tamoxifen. Exemestane was associated with a lower rate of thromboembolic events (1.3% vs 2.4%, P = .007).
Exemestane tablets were approved by the FDA and Previously European Commission (EC) for the treatment of advanced breast cancer in postmenopausal women after tamoxifen Progressed HAS All whose disease therapy. The new indication was approved by the EC in September 2005.