Pfizer’s Ibrance Breast Cancer Drug Gets Accelerated Approval

Pfizer’s novel breast cancer drug Ibrance shows reasonable evidence of clinical benefit to warrant marketing it ahead of a Phase III study, the FDA said in granting accelerated approval last week.

The agency approved the drug’s use in combination with Femara (letrozole) based on Phase II data showing the combination of Ibrance (palbociclib) and Femara extended progression-free survival by 20.2 months, compared with 10.2 months for Femara alone. Overall response rate was also higher in the Ibrance arm, Pfizer says.

Enrollment in the Phase III confirmatory trial that will eventually support full regular approval has already been completed.

Pfizer touts Ibrance as the first CD 4/6 inhibitor to see FDA approval; it works by blocking two key regulators of cancer cell growth. Ibrance will be indicated as a first-line treatment for postmenopausal women with metastatic estrogen receptor-positive HER2 negative breast cancer. — Lena Freund