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FDA Approves Palbociclib in Pretreated HR+/HER2-Negative Breast Cancer

Dr. Richard Pazdur

Liz Barrett

The FDA has approved palbociclib (Ibrance) for use in combination with fulvestrant in pretreated patients with HR-positive, HER2-negative metastatic breast cancer, according to Pfizer, the manufacturer of the CDK 4/6 inhibitor.

The approval is based on findings from the phase III PALOMA-3 trial, in which adding palbociclib to standard fulvestrant more than doubled progression-free survival (PFS) in pretreated patients with HR-positive, HER2-negative breast cancer. Palbociclib delayed disease progression by almost 5 months.

Palbociclib was initially approved by the FDA in February 2015 for use in combination with letrozole as a frontline treatment for postmenopausal women with ER-positive, HER2-negative metastatic breast cancer. Click here to read the full article at OncLive.com



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