Draft Nice Guidance on Advanced Breast Cancer Treatment, Halaven(R) Black Triangle Drug (Eribulin)
By Eisai Europe Limited, PRNEMonday, July 18, 2011
HATFIELD, England, July 20, 2011 -
The National Institute for Health and Clinical Excellence (NICE)
today issued draft guidance on Halaven® (eribulin) for
public consultation. The draft guidance does not recommend NHS
funding of eribulin, a treatment for locally advanced or metastatic
breast cancer.
Eribulin is a novel treatment indicated for patients with
locally advanced or metastatic breast cancer whose disease has
progressed after at least two chemotherapeutic regimens for
advanced and metastatic disease.[1] It was
launched in the UK in April 2011 and some patients have already
started to benefit from treatment. Before the approval of eribulin
in the EU, no single treatment has demonstrated a statistically
significant prolongation of median overall survival as shown in the
clinical trial.[2]
“We are hugely disappointed with the draft guidance issued by
NICE. It has not recommended an innovative treatment for a
vulnerable group of women with heavily pre-treated locally advanced
or metastatic breast cancer, with a proven overall survival
benefit,” commented Nick Burgin, European Director of Market
Access, Eisai. He adds; “Despite the UK price of eribulin currently
being the lowest in the world, and a further patient access scheme
agreement with the Department of Health which makes eribulin
available at a discounted price, and unique real-world comparative
data that has demonstrated overall survival, NICE’s unwillingness
to approve this treatment is a real surprise.”
There is a clear unmet need for treatments that improve overall
survival for women with locally advanced or metastatic breast
cancer, particularly those who do not respond or become refractory
to treatments such as anthracyclines and taxanes and, in many
cases, capecitabine.[3]
Eribulin is approved in the European Union, USA, Switzerland,
Japan, and Singapore. Eribulin is currently commercially available
in Austria, Denmark, Finland, Germany, Netherlands, Norway,
Portugal, Spain, Sweden, Singapore, Switzerland, United Kingdom,
and the USA and will become commercially available in Japan on 19
July 2011.
The draft guidance is based on the Phase III data showing a
median overall survival benefit of 13.1 months for patients
receiving eribulin compared to 10.6 months for patients receiving
‘treatment of physician’s choice’ (TPC).[4]
The side-effect profile of eribulin was expected and manageable.
The most commonly reported adverse reactions among patients were
asthenia (fatigue), neutropenia, alopecia (hair loss), peripheral
neuropathy (numbness and tingling in arms and legs), nausea and
constipation.[1] Limited inference
can be drawn from direct comparison of safety between patients
treated with eribulin and those treated with TPC, as each of the
therapies in the TPC group has a distinct safety profile. However,
comparisons between eribulin and TPC showed that serious adverse
events occurred in 25% of patients on eribulin and 26% of those on
TPC, and adverse events leading to therapy discontinuation occurred
in 13% of eribulin patients and 15% of TPC patients.
Professor Neville Davidson, Consultant Oncologist commented;
“Having treated patients with eribulin, there were no unexpected
side-effects in comparison with other treatments options in heavily
pre-treated patients with locally advanced or metastatic breast
cancer.”
Pre-planned analysis of patients from geographical region 1
(North America/Western Europe/Australia) best represent how
patients in the UK are managed and showed a significant overall
survival benefit of eribulin over TPC of 3.0 months, nominal
p=0.031 (updated analysis).[4]
Eisai is currently evaluating the ACD and will be responding to
the preliminary guidance to reverse the recommendations so that
more patients can benefit from treatment with eribulin.
Notes to Editors
Halaven is the EU trade name for eribulin.
Eribulin was launched on 20 April 2011 and is commercially
available in the UK. It is available via the Cancer Drug Fund and
through private insurance companies.
Global Phase III Clinical Study (EMBRACE)
EMBRACE was an open-label, randomised, global, multi-centre,
parallel two-arm study designed to compare overall survival in
patients treated with eribulin versus a Treatment of Physician’’s
Choice (TPC arm). TPC was defined as any single-agent chemotherapy,
hormonal treatment or biologic therapy approved for the treatment
of cancer; or palliative treatment or radiotherapy administered
according to local practice. The study included 762 patients with
metastatic breast cancer who previously had been treated with at
least two and a maximum of five prior chemotherapies, including an
anthracycline and a taxane. The vast majority (97%) of patients in
the TPC arm received
chemotherapy.[2]
The most common adverse reactions (incidence greater than or equal
to 19%) among patients treated with Eribulin were asthenia
(fatigue), neutropenia, alopecia (hair loss), peripheral neuropathy
(numbness and tingling in arms and legs), nausea and constipation.
The most common serious side effect reported in patients receiving
eribulin was neutropenia, with or without fever (occurring in 45%
and 5% of patients respectively).The most common adverse reaction
resulting in discontinuation of treatment with eribulin was
peripheral neuropathy (five
percent).[2]
Metastatic Breast Cancer
Breast cancer is now the most common cancer in the UK and the
lifetime risk of being diagnosed with breast cancer is 1 in 8 for
women in the UK.[5] In 2008, almost 47,700 women were
diagnosed with breast cancer, around 130 women a
day.[4]
Metastatic breast cancer is an advanced stage of the disease
that occurs when cancer spreads beyond the breast to other parts of
the body. Approximately five percent of women with breast cancer
will have metastatic disease at the time of diagnosis[6]
and others with local and regional disease may eventually develop
metastatic disease.[7] An estimated 13 percent of women
presenting with metastatic breast cancer will survive beyond five
years.[5]
Halaven® (eribulin)
Eribulin is a non-taxane, microtubule dynamics inhibitor indicated
for the treatment of patients with breast cancer who have
previously received at least two chemotherapeutic regimens for
metastatic disease and whose prior therapy should have included an
anthracycline and a taxane.[3]
Eribulin belongs to a class of antineoplastic agents, the
halichondrins, which are natural products, isolated from the marine
sponge Halichondria okadai. It is believed to work by inhibiting
the growth phase of microtubule dynamics without affecting the
shortening phase and sequesters tubulin into non-productive
aggregates.
About Eisai
Eisai is one of the world’s leading R&D-based pharmaceutical
companies that has defined its corporate mission as “giving first
thought to patients and their families and to increasing the
benefits health care provides,” which we call human health care
(hhc).
Eisai concentrates its R&D activities in three key
areas:
- Neuroscience: Alzheimer’s disease, multiple sclerosis,
neuropathic pain, epilepsy, depression, etc - Oncology: Anticancer therapies; tumour regression, tumour
suppression, antibodies, etc and Supportive cancer therapies; pain
relief, nausea, etc - Vascular/Immunological Reaction: Acute coronary syndrome,
atherothrombotic disease, sepsis, rheumatoid arthritis, psoriasis,
Crohn’s disease, etc
With operations in the U.S., Asia, Europe and its domestic home
market of Japan, we employ more than 10,000 people worldwide, and
reported consolidated sales of over £3.53 billion in FY2007, an
increase of 8.9% year on year. In Europe, Eisai undertakes sales
and marketing operations in over 20 markets, including the United
Kingdom, France, Germany, Italy, Spain, Switzerland, Sweden,
Ireland, Austria, Denmark, Finland, Norway, Portugal, Iceland,
Czech Republic, Hungary, Slovakia and the Netherlands.
For further information please visit our web site
References
1. Summary of Product Characteristics Halaven (updated March
2011). Available at:
www.medicines.org.uk/EMC/medicine/24382/SPC/Halaven+0.44+mg+ml+solution+for+injection/
2. Jassem J, Carroll C, Ward SE, Simpson E, Hind D. The clinical
efficacy of cytotoxic agents in locally advanced or metastatic
breast cancer patients pretreated with an anthracycline and a
taxane: a systematic review. Eur J Cancer. 2009
Nov;45(16):2749-58.
3. National Institute for Health and Clinical Excellence. NICE
clinical guideline 81: Advanced breast cancer: diagnosis and
treatment - full guideline. 2009.
4. Cortes J, O’Shaughnessy J, Loesch D, et al. Eribulin
monotherapy versus treatment of physician’s choice in patients with
metastatic breast cancer (EMBRACE): a phase 3 open-label randomised
study. The Lancet. 2011; 377: 914 -923
5. Cancer Research UK. Cancer Statistics -– Key Facts. Available
from URL
(Accessed 1 April 2011)
6. Cancer Research UK. Statistics and outlook for breast cancer.
Available from URL
www.cancerhelp.org.uk/type/breast-cancer/treatment/statistics-and-outlook-for-breast-cancer
(Accessed 1 April 2011)
7. Cancer Research UK. Statistics and outlook for breast cancer.
Available from URL
www.cancerhelp.org.uk/type/breast-cancer/treatment/statistics-and-outlook-for-breast-cancer
(Accessed 1 April 2011)
Media Enquiries, Eisai Europe Ltd, Cressida Robson, +44-7908-314-155, Cressida_Robson at eisai.net; Tonic Life Communications, Benjamyn Tan / Helen Swift
+44(0)207-798-9262 / +44(0)7792-034-191, benjamyn.tan at toniclc.com
helen.swift at toniclc.com
Tags: Eisai Europe Limited, England, Hatfield, July 20, United Kingdom
