First EU approval for fulvestrant in combination with a CDK4/6 inhibitor Fulvestrant in combination with palbociclib showed progression-free survival (PFS) improvement of 4.9 months compared to combination of fulvestrant with placebo2 CAMBRIDGE, England--(BUSINESS WIRE)--AstraZeneca today 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 fulvestrant 500 mg and palbociclib 125 mg over fulvestrant and placebo (HR: 0·46; 95% CI: 0·36–0·59; p<0·0001).2 – ENDS – NOTES TO EDITORS
About Advanced Breast Cancer
About PALOMA-3 Patients enrolled in this study had a median age of 57 years (range 29 to 88). The majority of patients in the study were white (74%). All patients had an ECOG (Eastern Cooperative Oncology Group) PS of 0 or 1, and 80% were postmenopausal. All patients had received prior systemic therapy and 75% of patients had received a previous chemotherapy regimen. Twenty-five percent of patients had received no prior therapy in the metastatic disease setting, 60% had visceral metastases, and 22% had bone only disease. Fulvestrant 500 mg was given as two 5 ml injections, one in each buttock, on days 1, 15, 29 and once monthly (28 ± 3 days) thereafter. Palbociclib was given orally at a dose of 125 mg daily for 21 consecutive days followed by 7 days off treatment. Patients continued to receive their assigned treatment until objective disease progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.
About Fulvestrant In the US, fulvestrant is licensed for use with palbociclib for the treatment of women with HR+, HER2- locally advanced or metastatic breast cancer, whose cancer has progressed after endocrine therapy. In Japan, fulvestrant is also approved for use in combination with any CDK4/6 inhibitor. Fulvestrantrepresents a hormonal treatment approach that helps to slow tumour growth by blocking and degrading the oestrogen receptor – a key driver of disease progression. Fulvestrant is approved in over 80 countries as a monotherapy to treat ER+ advanced breast cancer patients. It is currently being evaluated in combination with medicines from various drug classes for the treatment of women with HR+ advanced breast cancer.
About AstraZeneca in Oncology By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody-Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.
About AstraZeneca References
1 European Commission. Pharmaceuticals - Community Register. Available from: http://ec.europa.eu/health/documents/community-register/html/h269.htm [Last Accessed November 2017]
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