Business Wire

FASLODEX (FULVESTRANT) RECEIVES POSITIVE CHMP OPINION FOR THE TREATMENT OF HORMONE RECEPTOR-POSITIVE ADVANCED BREAST CANCER IN COMBINATION WITH PALBOCICLIB1

Jaa

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.1 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%).2

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.

– ENDS –

NOTES TO EDITORS

About PALOMA-3

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.

About Fulvestrant

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.

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.

References

1 European Medicines Agency (EMA) summary of opinion. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/000540/WC500236626.pdf [Last Accessed October 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

Contact information

AstraZeneca
Karen Birmingham
+44 (0)7818 524012
or
Hugues Joublin
+1 301 398 3041
or
Lauren Friedman
+44 (0)7384 239333

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme tältä julkaisijalta, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

OTEZLA® (Apremilast) Phase III Data Showed Significant Improvements in Patients with Active Behçet’s Disease with Oral Ulcers18.2.2018 00:00Tiedote

Celgene Corporation (NASDAQ:CELG) today announced that data from the phase III RELIEF™ clinical trial of OTEZLA® (apremilast) in patients with active Behçet’s Disease with oral ulcers were presented in a late-breaking oral presentation at the 2018 American Academy of Dermatology (AAD) Annual Meeting. The results showed statistically significant reductions in oral ulcers with apremilast 30 mg twice daily (BID) versus placebo through week 12. OTEZLA (apremilast) is Celgene’s oral selective inhibitor of phosphodiesterase 4 (PDE4). Behçet’s Disease is a rare, chronic, multi-system inflammatory syndrome. Oral ulcers, the most common manifestation of Behçet’s Disease, can be disabling and have a substantial effect on quality of life. This study primarily evaluated the effect of apremilast on recurring oral ulcers in patients with active Behçet’s Disease who were previously treated with at least one topical or systemic medication. “Reducing oral ulcers, which are painful and can negatively im

CT-P13 (biosimilar infliximab) is comparable to reference infliximab and adalimumab in highly anticipated real-world study17.2.2018 11:00Tiedote

Twelve-month data from the Personalised Anti-TNF therapy in Crohn’s disease Study (PANTS) was presented at the 13th Congress of the European Crohn’s and Colitis Organisation (ECCO). The results indicate that the clinical effectiveness, safety and immunogenicity of Celltrion Healthcare’s CT-P13 (biosimilar infliximab) in patients with Crohn’s disease (CD) is comparable to those treated with reference infliximab as well as those treated with adalimumab.1 The UK-wide, three-year prospective observational study investigated primary non-response (PNR), loss of response (LOR) and adverse drug reactions (ADR) to infliximab (reference infliximab and CT-P13) and adalimumab in 1610 CD patients. The data show comparable efficacy between CT-P13, reference infliximab and adalimumab in relation to PNR, LOR and ADR rates. In addition, at week 54, the remission rate was 39.7%, 39.0% and 32.7% for reference infliximab, CT-P13 and adalimumab treated patients, respectively.1 The PANTS study investigates

Avanti Communications HYLAS 4 Satellite Arrives in French Guiana16.2.2018 21:26Tiedote

Avanti Communications Group plc (“Avanti”), a leading provider of satellite data communications services in Europe, the Middle East and Africa (“EMEA”), announces its HYLAS 4 satellite has arrived safely in French Guiana ahead of its March 2018 launch. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180216005586/en/ Avanti Communications HYLAS 4 Satellite Arrives in French Guiana (Photo: Business Wire) The spacecraft, built by Orbital ATK was packed and shipped at their Satellite Manufacturing Facility in Dulles, Virginia, United States and flown to French Guiana, where it was unloaded and will be taken to the Arianespace launch facilities in Kourou. HYLAS 4 uses the latest High Throughput Satellite technology, doubling Avanti's Ka-band capacity across EMEA. The latest addition to Avanti's HYLAS fleet will provide: Backhaul services for mobile network operators Wholesale broadband for ISPs Connectivity for governments (civil a

General Cable Corporation Stockholders Approve Acquisition By Prysmian Group16.2.2018 20:05Tiedote

General Cable Corporation (NYSE: BGC) today announced the voting results from the Company’s special meeting of stockholders held this morning. Stockholders of General Cable approved the Company’s previously announced acquisition by Prysmian Group (BIT: PRY) for $30.00 per share in cash. A total of 38,140,754 shares, representing approximately 75.34% of the total number of shares of common stock outstanding and approximately 99% of the total votes cast, were voted in favor of the merger. Subject to regulatory approvals and other customary closing conditions, the transaction is expected to close by the third quarter of 2018. About General Cable General Cable (NYSE:BGC), with headquarters in Highland Heights, Kentucky, is a global leader in the development, design, manufacture, marketing and distribution of aluminum, copper and fiber optic wire and cable products for the energy, communications, automotive, industrial, construction and specialty segments. General Cable is one of the larges

Systemic Sclerosis World Congress:Inspirational Patient Stories Reveal the Challenging Realities of Living with Devastating Rare Disease16.2.2018 12:03Tiedote

Boehringer Ingelheim today unveils a new phase of 'More Than Scleroderma: The Inside Story', and launches the new patient website www.morethanscleroderma.com. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180216005188/en/ Anna, 36, living with scleroderma (Photo: Business Wire) The global initiative highlights the importance of understanding the ‘inside story’ of each individual living with scleroderma, also known as systemic sclerosis. To coincide with the Systemic Sclerosis World Congress in Bordeaux, 15-17 February 2018, new and truly inspiring patient stories are revealed, reflecting the real-life, diverse and very moving journeys of people living with scleroderma across the world. The campaign will also be launched in the U.S. The new website www.morethanscleroderma.com features a powerful collection of photographs and video stories of people living with scleroderma across the world, revealing the life-changing impact o

Philip Morris International Recognized as a Global Top Employer for the Second Year in a Row16.2.2018 11:00Tiedote

Philip Morris International Inc. (PMI) (NYSE/Euronext Paris: PM) today is recognized for the second year in a row as a Global Top Employer. This year’s certification from the Top Employer Institute is awarded to PMI teams in 44 countries, a testament to the company’s consistency and excellence in offering an enriching and dynamic work environment, and exceptional development opportunities for employees across the globe. PMI has been recognized by the Top Employer Institute for six consecutive years. This year, PMI was awarded with five regional certifications in Europe, the Middle East, Africa and, for the first time, in North America and Latin America. Additionally, Indonesia was the first PMI affiliate to be certified in Asia. “It is a proud moment for all of us at PMI,” said Charles Bendotti, PMI Senior Vice President, People and Culture. “Our success as a company relies on the men and women who come to work every day with a passion to achieve, and a willingness to learn, grow, and

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme