FDA Expands Tykerb Approval

Por Ilene Winkler

De Mets Matters Blog

Good news for women with metastatic breast cancer! On January 29^th the FDA approved a new drug option for HER2+ metastatic women: Tykerb in combination with Femara. Tykerb was previously approved only in combination with Xeloda, an oral chemotherapy. The FDA based its approval on a clinical trial in which women taking the combination of Tykerb and Femara had an average of 35 weeks without recurrence, compared to 13 weeks for those taking Femara alone. No data is available yet on whether this will translate into a longer survival advantage. Femara is a hormonal treatment that most women can tolerate much better than Xeloda, so this new oral drug combination may offer a much easier regimen for HER2+ metastatic women, and FDA approval means that Medicare and private insurance companies will now begin paying for this treatment combination if they are not already. For more information you can check the FDA website or the bcmets.org message boards.

Anunciado 2 febrero 2010.