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First EU approval for fulvestrant in combination with a CDK4/6 inhibitor


16 November, 2017  

AstraZeneca has announced that the European Commission (EC) has approved a new indication for Faslodex (fulvestrant) in combination with a CDK4/6 inhibitor, palbociclib, for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer in women who have received prior endocrine therapy.1

David Fredrickson, Executive Vice President, Head of the Oncology Business Unit at AstraZeneca, said: “For many years fulvestrant has been used as an effective monotherapy treatment for women with hormone receptor positive breast cancer. The first EU approval of fulvestrant for use in combination with a CDK4/6 inhibitor reinforces the value of fulvestrant as an endocrine agent of choice for advanced breast cancer patients, building on the EU first-line monotherapy approval earlier this year with FALCON.”

The EU approval is based on data from the Phase III PALOMA-3 trial, which showed a statistically significant increase in investigator-assessed median PFS of 4.9 months (9.5 months vs 4.6 months) in patients who received fulvestrant500 mg and palbociclib 125mg over fulvestrant and placebo (HR: 0·46; 95% CI: 0·36–0·59; p<0·0001).2

References

  1. European Commission. Pharmaceuticals – Community Register. Available from: http://ec.europa.eu/health/documents/community-register/html/h269.htm[Last Accessed November 2017]
  2. Cristofanilli M, 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. Lancet Oncol. 2016 Apr;17(4):425-39