Breast Cancer Treatment Receives ‘Breakthrough Therapy’ Designation

Pfizer announced that the FDA has granted Breakthrough Therapy designation for its investigational compound palbociclib (PD-0332991), an oral and selective inhibitor of cyclin dependent kinases (CDK) 4 and 6 for the potential treatment of patients with breast cancer.

The Breakthrough Therapy designation was based on preliminary Phase 2 data in post-menopausal patients with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer. Interim data demonstrated that women treated with a combination of palbociclib plus letrozole (Femara; Novartis) achieved a statistically significant improvement in median progression free survival (PFS) compared to women who received letrozole alone (26.1 months and 7.5 months, respectively).

Pfizer has initiated a randomized, multi-center, double-blind Phase 3 study (Study 1008) evaluating palbociclib in combination with letrozole vs. letrozole alone as a first-line treatment for post-menopausal patients with ER+, HER2- locally advanced or metastatic breast cancer.

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