FDA Approval: Palbociclib for the Treatment of Postmenopausal Patients with Estrogen Receptor–Positive, HER2-Negative Metastatic Breast Cancer

  title={FDA Approval: Palbociclib for the Treatment of Postmenopausal Patients with Estrogen Receptor–Positive, HER2-Negative Metastatic Breast Cancer},
  author={Julia A Beaver and Laleh Amiri-Kordestani and Rosane Charlab and Wei Chen and Todd R. Palmby and Amy Tilley and Jeanne Fourie Zirkelbach and Jingyu Yu and Qi Liu and Liang Zhao and Joyce Z. Crich and Xiao Hong Chen and Minerva Hughes and Erik W. Bloomquist and Shenghui Tang and Rajeshwari Sridhara and Paul G Kluetz and Geoffrey Kim and Amna Ibrahim and Richard Pazdur and Patricia Cortazar},
  journal={Clinical Cancer Research},
  pages={4760 - 4766}
On February 3, 2015, the FDA granted accelerated approval to palbociclib (IBRANCE, Pfizer Inc.), an inhibitor of cyclin-dependent kinases 4 and 6 (CDK4 and CDK6), for use in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)–positive, HER2-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease. The approval is based on a randomized, multicenter, open-label phase I/II trial (PALOMA-1) in 165 patients… 

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