FDA Approves Palbociclib for Metastatic Breast Cancer

The FDA has granted an accelerated approval to palbociclib (Ibrance) as a frontline treatment for postmenopausal women with estrogen receptor (ER)-positive, HER2-negative metastatic breast cancer, based on findings from the phase 2 PALOMA-1 trial.

In the open-label phase 2 study, treatment with letrozole plus the novel CDK 4/6 inhibitor palbociclib reduced the risk of disease progression by 51% compared with letrozole alone. The median progression-free survival (PFS) with palbociclib was 20.2 months versus 10.2 months for letrozole alone (Hazard ratio [HR] = 0.488; P = .0004).

Palbociclib was approved under the FDA’s Breakthrough Therapy designation and priority review program, which provides an expedited approval process for treatments that provide a substantial benefit over current options. The FDA was not scheduled to make a decision on the drug’s application until April 2015. “The addition of palbociclib to letrozole provides a novel treatment option to women diagnosed with metastatic breast cancer,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “The FDA is committed to expediting marketing approval of cancer drugs through our accelerated approval regulations.”

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