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

@article{Beaver2015FDAAP,
  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 W Tang and Rajeshwari Sridhara and Paul Gustav Kluetz and Geoffrey Kim and Amna Ibrahim and Richard Pazdur and Patricia Cortazar},
  journal={Clinical Cancer Research},
  year={2015},
  volume={21},
  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… Expand
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In summary, palbociclib plus endocrine therapy is an effective treatment option for North American women with hormone receptor–positive/human epidermal growth factor receptor 2–negative advanced breast cancer. Expand
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The magnitude of clinical benefit seen with the addition of palbociclib to letrozole in improving both median PFS and clinical benefit response (CBR) rate is consistent in nearly all subgroups analyzed, and consistent with that seen in the overall study population. Expand
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Palbociclib in combination with endocrine therapy shows an unexpectedly high CBR and favorable safety profile in heavily pretreated endocrine-resistant estrogen receptor-positive, HER2-negative MBC patients. Expand
Palbociclib and Letrozole in Advanced Breast Cancer.
TLDR
Among patients with previously untreated ER-positive, HER2-negative advanced breast cancer, palbociclib combined with letrozole resulted in significantly longer progression-free survival than that with let rozole alone, although the rates of myelotoxic effects were higher with palbokiclib-letrozoles. Expand
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From a societal perspective, PAL treatment of both patient groups (with and without prior endocrine therapy) is highly unlikely to be cost-effective compared with the usual care in the USA. Expand
Treatment Patterns and Outcomes Associated With Palbociclib Plus Letrozole for Postmenopausal Women With HR-/HER2- Advanced Breast Cancer Enrolled in an Expanded Access Program.
TLDR
Most patients derived benefit from palbociclib + letrozole treatment despite having received multiple prior treatment lines for metastatic disease, and the disease of most patients was heavily pretreated. Expand
Impact of palbociclib combinations on treatment of advanced estrogen receptor-positive/human epidermal growth factor 2-negative breast cancer
  • K. Boér
  • Medicine
  • OncoTargets and therapy
  • 2016
TLDR
The first cyclin-dependent kinases 4/6 (CDK4/6) inhibitor, palbociclib, received accelerated US Food and Drug Administration approval for use in combination with letrozole for the treatment of postmenopausal ER+ve/HER2−ve advanced breast cancer as initial, endocrine-based therapy in 2015. Expand
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TLDR
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