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NICE approves palbociclib with fulvestrant for HER2-negative breast cancer

NICE has approved palbociclib (Ibrance) with fulvestrant for use within the Cancer Drugs Fund as an option for treating hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer in people who have had previous endocrine therapy, if exemestane plus everolimus is the most appropriate alternative to a cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitor.

The decision is based on evidence from the multicentre double-centre randomised placebo-controlled trial comparing palbociclib and fulvestrant (n=347) with placebo and fulvestrant (n=174) in 521 women with hormone receptor-positive, HER2‑negative advanced breast cancer.

Treatment with palbociclib plus fulvestrant increased median progression-free survival (PFS) compared with fulvestrant alone from 4.6 months to 11.2 months (hazard ratio [HR] 0.50; 95% CI 0.398-0.620; P<.0001).

Palbociclib plus fulvestrant resulted in a median 6.9 months gain in overall survival (OS), although this was not statistically significant.

Treatment discontinuation with palbociclib plus was much lower than reported for everolimus plus exemestane in the BOLERO‑2 trial, which compared everolimus plus exemestane with exemestane alone.

Clinical trial evidence suggests that compared with fulvestrant alone, palbociclib with fulvestrant increases the length of time before the disease progresses. However, it is not known whether palbociclib increases the length of time people live, because the final trial results are not available yet.

Because of the uncertainty regarding OS benefit, NICE approved the combination for use on the CDF in order to allow more evidence to be collected.


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