Astrazeneca Regulatory News (AZN)

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29 August 2017 07:00 BST

FASLODEX RECEIVES US FDA APPROVAL aS MONOTHERAPY FOR Expanded use IN breast cancer

20% reduction in disease progression vs anastrozole, a current standard treatment option

Expanded approval provides earlier benefit for advanced breast cancer patients not previously treated with endocrine therapy

AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Faslodex (fulvestrant) 500mg as monotherapy for expanded use in women with hormone-receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer, who have gone through menopause and have not received previous endocrine therapy.

The FDA approval is based on data from the Phase III FALCON trial, which were published in the November 2016 issue of The Lancet. 

Jamie Freedman, Executive Vice President, Head of the Oncology Business Unit, AstraZeneca said: "We're pleased that the landmark FALCON trial results demonstrated the efficacy of Faslodex as initial monotherapy treatment for women who are living with HR+ HER2- advanced breast cancer. This approval, building on more than 15 years of clinical experience, means more patients can have the opportunity to receive Faslodex earlier in the treatment journey."Matthew Ellis, MD, PhD, Director of the Lester and Sue Smith Breast Center, part of the NCI-designated Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine, said: "This study provides evidence that using fulvestrant as the first option for previously untreated hormone receptor-positive advanced breast cancer will prolong the time before the disease advances and alternative therapies are required."

The FALCON trial was designed to demonstrate superiority and included 462 postmenopausal women with HR+ metastatic or locally-advanced breast cancer. The results showed a statistically-significant increase in investigator-assessed median progression-free survival (PFS), representing a 20% reduction in the risk of disease progression or death - median PFS of 16.6 months in patients who received Faslodex, compared to 13.8 months in patients receiving the aromatase inhibitor anastrozole 1mg (HR: 0.797; 95% CI: 0.637-0.999; p=0.049).

Faslodex is a hormonal therapy that targets the oestrogen receptor (ER), which can influence the growth of HR+ metastatic breast cancer (MBC), and helps to slow cancer growth by blocking the ER and targeting it for degradation. The most common adverse reactions (≥10%) of any grade reported in patients in the Faslodex arm were arthralgia, hot flash, fatigue, and nausea.

About FALCON

The FALCON (Fulvestrant and AnastrozoLe COmpared in hormonal therapy-Naïve advanced breast cancer) trial is a Phase III, randomised, double-blind, multicentre trial comparing the antitumour effects and tolerability profile of a 500mg dose of Faslodex plus placebo with a 1mg dose of anastrozole plus placebo, in postmenopausal women with HR+, locally-advanced or metastatic breast cancer who have not been treated previously with any hormonal medicine.

The FALCON trial was designed on the basis of positive results from the Phase II FIRST trial, which demonstrated a median overall survival nearly six months longer with Faslodex compared to anastrozole.

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.

About Faslodex

First approved in 2002, Faslodex was used as a monotherapy for the treatment of postmenopausal women with HR+ MBC whose cancer had progressed following prior anti-oestrogen therapy. In 2016, FDA approved Faslodex in combination with palbociclib for the treatment of women with HR+, HER2- advanced or MBC, whose cancer has progressed after endocrine therapy.

On 26 July 2017, the European Commission (EC) approved Faslodex for the treatment of oestrogen-receptor positive, locally-advanced breast cancer in postmenopausal women not previously treated with endocrine therapy. 

About AstraZeneca in OncologyAstraZeneca 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.

About AstraZeneca

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 www.astrazeneca.com and follow us on Twitter @AstraZeneca. 

Adrian Kemp

Company Secretary, AstraZeneca PLC