CAMBRIDGE, ENGLAND--( / ) October 16, 2017 -- AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending a new indication for Faslodex (fulvestrant) that will expand its use to include combination therapy with palbociclib. The combination use is 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.
Klaus Edvardsen, Head of Oncology Global Medicines Development at AstraZeneca said: “This positive CHMP opinion builds on the growing body of evidence around the potential of fulvestrant in combination with targeted therapies, such as palbociclib. Fulvestrant -based treatment regimens may provide new options for patients with advanced breast cancer for whom there is still an unmet medical need. This is why many current clinical trials exploring the effects of combination therapies in this patient population are using fulvestrant.”
The CHMP opinion is based on data from the Phase III PALOMA-3 trial. The combination of fulvestrant 500 mg and palbociclib 125 mg resulted in a 4.9 month progression-free survival (PFS) improvement over fulvestrant and placebo in women with HR+, HER2- advanced breast cancer whose disease had progressed after endocrine therapy. Improvement in PFS was seen regardless of menopausal status.2 The most-commonly reported adverse events (AEs) in fulvestrant plus palbociclib compared to fulvestrant plus placebo were neutropenia (81% vs 3%), leukopenia (50% vs 4%) and infections (42% vs 30%).
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 over 19 different medicines for the treatment of women with HR+ advanced breast cancer. Most recently, fulvestrant was approved in Japan by the Pharmaceuticals and Medical Devices Agency for use in combination with a CDK4/6 inhibitor.
Fulvestrant slows tumour growth by binding to and degrading the oestrogen receptor - a key driver of breast cancer progression in some women. It is widely approved for the treatment of HR+ advanced breast cancer in postmenopausal women with disease progression following anti-oestrogen medicine.
PALOMA-3 is a Phase III international, randomised, double-blind, parallel group, multicentre study of fulvestrant plus palbociclib versus fulvestrant plus placebo conducted in women with HR+/HER2- advanced or metastatic breast cancer, regardless of their menopausal status, whose disease progressed after endocrine therapy. The study evaluated 521 pre/postmenopausal women who were randomised 2:1 to fulvestrant plus palbociclib or fulvestrant plus placebo. Women who were either premenopausal (meaning they had not reached menopause), or perimenopausal (meaning that their bodies were making the natural transition toward menopause), were therapeutically induced to become postmenopausal and represented 20.7% of the study population.
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 Advanced Breast Cancer
Advanced/metastatic breast cancer refers to Stage III and IV breast cancer. Stage III disease may also be referred to as locally-advanced breast cancer, while metastatic disease is the most-advanced stage of breast cancer (Stage IV), and occurs when cancer cells have spread beyond the initial tumour site to other organs of the body outside the breast. Since there is no cure for the disease, the goal of current treatment is to delay disease worsening or death.
Fulvestrant is indicated for the treatment of oestrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy, or with disease relapse on or after adjuvant anti-oestrogen therapy, or disease progression on anti-oestrogen therapy.
In the US and Japan, fulvestrant is also approved, in combination with palbociclib, for the treatment of women with HR+, HER2-negative advanced or metastatic breast cancer, whose cancer has progressed after endocrine medicine. Fulvestrant represents 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 over 19 different medicines for the treatment of women with HR+ advanced breast cancer.
About AstraZeneca in Oncology
AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca’s five Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy as illustrated by our investment in Acerta Pharma in haematology.
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.
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit and follow us on Twitter @AstraZeneca.
 European Medicines Agency (EMA) summary of opinion. Available from: [Last Accessed October 2017]
 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
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