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NICE Approves Palbociclib Combo for HR+ Advanced Breast Cancer

Gina Columbus @ginacolumbusonc
Published: Monday, Dec 02, 2019

breast cancer
The UK National Institute for Health and Care Excellence (NICE) has approved palbociclib (Ibrance) in combination with fulvestrant (Faslodex) for the treatment of female patients with hormone receptor (HR)–positive, HER2-negative locally advanced or metastatic breast cancer who have received prior endocrine therapy.1

In April 2019, the FDA expanded the approval of palbociclib capsules in combination with endocrine therapy to include male patients with HR-positive, HER2-negative advanced or metastatic breast cancer.


  1. Final appraisal document: palbociclib with fulvestrant for treating hormone receptor-positive, HER2-negative, advanced breast cancer. National Institute for Health and Care Excellence. Published November 28, 2019. Accessed December 2, 2019.
  2. Cristofanilli M, Slamon DJ, Ro J, et al. Overall survival with palbociclib plus fulvestrant in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC): analyses from PALOMA-3. Presented at: 2018 ESMO Congress; October 19-23, 2018; Munich, Germany. Abstract LBA2_PR.
  3. Turner NC, Slamon DJ, Ro, I, et al. Overall survival with palbociclib and fulvestrant in advanced breast cancer. N Engl J Med. 2018; 379:1926-1936. doi: 10.1056/NEJMoa1810527.
  4. Cristofanilli M, Turner NC, Bondarenko I, et al. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial [erratum in Lancet Oncol. 2016;17(4):e136. Lancet Oncol. 2016;17(7):e270]. Lancet Oncol. 2016;17(4):425-439. doi: 10.1016/S1470-2045(15)00613-0.

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