New Long-term Data Published in Journal of Clinical Oncology Support That Femara Is More Effective Than Tamoxifen
• BIG 1-98 four-year results show Femara further reduced risk
of early breast cancer returning compared with tamoxifen
• Femara significantly reduced risk of cancer spreading to
other parts of the body
EAST HANOVER, NJ, Feb. 20, 2007 – Long-term follow-up data
from the independent Breast International Group (BIG) 1-98 trial
support earlier findings that Femara (letrozole tablets) is more
effective than tamoxifen as initial post-surgery therapy for early
breast cancer. The updated study results were published in the
February 10 issue of the Journal of Clinical Oncology (SEE
ATTATCHMENT).
At a median follow-up of more than four years (51 months), Femara
reduced the risk of breast cancer recurrence by an additional 18%
as well as the risk of distant metastases (the breast cancer
spreading to other parts of the body) by an additional 19% versus
tamoxifen in postmenopausal women with hormone-sensitive early
breast cancer. The data on distant metastases is particularly
important because cancer that spreads to other parts of the body
increases the likelihood that a woman will die from the
disease.
This new analysis included nearly 5,000 women assigned to receive
five years of Femara or tamoxifen. More than 1,200 women completed
five years of treatment. The primary core analysis conducted at a
median follow-up of 26 months also included women assigned to
receive Femara or tamoxifen for two years followed by three years
of the other agent.
“The four-year data in this population is consistent with our
initial findings that letrozole may help protect women from breast
cancer recurrence and distant spread better than tamoxifen,”
said Alan Coates, M.D., clinical professor, School of Public
Health, University of Sydney, Australia, who authored the study.
“The publication of this longer-term analysis from BIG 1-98
will help physicians more clearly evaluate the contribution of
letrozole in managing breast cancer.”
The current analysis strengthens the evidence of the broad range of
patients who may benefit from Femara. Femara significantly improved
disease-free survival (a measure of disease recurrence) in the
overall study population. In women with node positive disease,
Femara significantly reduced the risk of recurrence by a further
23% versus tamoxifen. In women who received chemotherapy, the
reduction was a further 26%. These two groups of women are more
likely to have their breast cancer return. Women with node negative
disease and those who did not receive chemotherapy were also
evaluated.
An improvement in disease-free survival in node negative patients
also emerged with longer follow-up. In the current analysis, Femara
reduced the risk of breast cancer coming back in this group of
women by 12% versus 4% observed at the primary core analysis,
though this did not achieve statistical significance. Women with
node negative disease tend to experience recurrence later than
women with node positive disease.
The overall safety profile was consistent with the primary core
analysis. Extensive and rigorous collection of safety data in this
patient population over four years showed that adverse events for
both Femara and tamoxifen were similar to previously reported
results from this trial.
“As data from BIG 1-98 mature, they consistently provide
physicians with evidence of the compelling benefits of Femara as
adjuvant therapy over tamoxifen, particularly the significant
reductions in distant disease spread,” said Diane Young,
M.D., vice president, head, Global Medical Affairs, Novartis
Oncology. “These data may help guide physicians’
treatment decisions when choosing between aromatase
inhibitors.”
Femara is the only medicine in its class indicated for women with
hormone-dependent breast cancer taken as either initial treatment
immediately after surgery (adjuvant setting) or after they have
completed five years of tamoxifen therapy (extended adjuvant
setting).
About BIG 1-98
BIG 1-98 is the only clinical trial that incorporates both a
head-to-head comparison and a sequencing of Femara and tamoxifen as
adjuvant treatment for postmenopausal women with hormone
receptor-positive breast cancer. The results of the primary core
analysis of the head-to-head comparison based on a median follow-up
of 26 months were published in the December 29, 2005 issue of the
New England Journal of Medicine. The BIG 1-98 trial was conducted
by the International Breast Cancer Study Group (IBCSG) with many
independent centers and was supported by Novartis.
About Femara
Femara is a once-daily oral prescription medication approved for
the adjuvant (following surgery) treatment of postmenopausal women
with hormone receptor-positive early breast cancer. The benefits of
Femara in clinical trials are based on 24 months of treatment.
Further follow-up will be needed to determine long-term results,
including safety and efficacy.
Femara is also approved for the extended adjuvant treatment of
early stage breast cancer in postmenopausal women who are within
three months of completion of five years of adjuvant tamoxifen
therapy. The benefits of Femara in the extended adjuvant setting
are based on 24 months of treatment. Further follow-up will be
needed to determine long-term results, including side
effects.
Femara is also approved for the first-line treatment of
postmenopausal women with hormone receptor-positive or hormone
receptor-unknown locally advanced or metastatic breast cancer.
Femara is also indicated for the treatment of advanced breast
cancer in postmenopausal women with disease progression following
antiestrogen therapy.
Important safety information
Patients must be postmenopausal to take Femara. Patients should
talk to their doctor if they are allergic to Femara or any of its
ingredients. Patients should not take Femara if they are pregnant
as it may cause fetal harm. Some women reported fatigue and
dizziness with Femara. Until patients know if Femara affects them,
they should use caution before driving or operating machinery. Some
patients taking Femara had an increase in cholesterol. Additional
follow-up is needed to determine the risk of bone fracture
associated with long-term use of Femara.
In the adjuvant setting, commonly reported side effects are
generally mild to moderate. Side effects that are comparable
between Femara and tamoxifen include night sweats, weight gain,
nausea, and tiredness. Side effects seen more often with tamoxifen
vs. Femara were hot flashes and vaginal bleeding. Joint pain was
experienced more often with Femara vs. tamoxifen. The incidence of
stroke was 1.1% for women on Femara and 1.0% for women on
tamoxifen, and the incidence of other cardiovascular events was
6.6% for Femara vs. 6.2% for tamoxifen. The percentage of women on
Femara reporting bone fracture was 5.6% vs. 4% for women on
tamoxifen. The percentage of women reporting osteoporosis was 2%
for Femara vs. 1.1% for tamoxifen.
In the extended adjuvant setting, commonly reported side effects
are generally mild to moderate. Those seen more often with Femara
vs. placebo were hot flashes (50% vs. 43%), joint pain (22% vs.
18%) and muscle pain (7% vs. 5%). Other side effects, which were
comparable to placebo, include fatigue (34% vs. 32%), swelling due
to fluid retention (18% vs. 16%), headache (20% vs. 20%), increase
in sweating (24% vs. 22%) and increase in cholesterol (16% vs.
16%). The percentage of patients on Femara vs. placebo reporting a
fracture was 5.9% vs. 5.5%. The percentage of patients reporting
osteoporosis was 6.9% vs. 5.5%. Bisphosphonates, drugs to increase
bone strength, were given to 21.1% of Femara patients and 18.7% of
placebo patients.
In the metastatic setting, commonly reported side effects are
generally mild to moderate and may include bone pain, hot flashes,
back pain, nausea, joint pain, shortness of breath, fatigue,
coughing, constipation, limb pain, chest pain, and headache.
The foregoing release contains forward-looking statements that can
be identified by terminology such as “likelihood,”
“may,” “will,” “more likely,”
or similar expressions, or by express or implied discussions
regarding potential future sales of Femara, or regarding the
long-term impact of a patient's use of Femara. Such forward-looking
statements involve known and unknown risks, uncertainties and other
factors that may cause actual results with Femara to be materially
different from any future results, performance or achievements
expressed or implied by such statements. There can be no guarantee
that Femara will reach any particular sales levels. Neither can
there be any guarantee regarding the long-term impact of a
patient’s use of Femara. In particular, management's
expectations regarding Femara could be affected by, among other
things, unexpected clinical trial results, including additional
analysis of existing clinical data, or new clinical data;
unexpected regulatory actions or delays or government regulation
generally; competition in general; increased government, industry,
and general public pricing pressures; the company's ability to
obtain or maintain patent or other proprietary intellectual
property protection; and other risks and factors referred to in the
Company's current Form 20-F on file with the U.S. Securities and
Exchange Commission. Should one or more of these risks or
uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially from those
anticipated, believed, estimated or expected. Novartis is providing
the information in this press release as of this date and does not
undertake any obligation to update any forward-looking statements
contained in this press release as a result of new information,
future events or otherwise.
For more information
Additional information regarding Femara or Novartis Oncology can be
found on the websites www.femara.com or www.novartisoncology.com.
About Novartis
Located in East Hanover, New Jersey, Novartis Pharmaceuticals
Corporation is an affiliate of Novartis AG (NYSE: NVS), a world
leader in offering medicines to protect health, cure disease and
improve well-being. Our goal is to discover, develop and
successfully market innovative products to treat patients, ease
suffering and enhance the quality of life. We are strengthening our
medicine-based portfolio, which is focused on strategic growth
platforms in innovation-driven pharmaceuticals, high-quality and
low-cost generics, human vaccines and leading self-medication OTC
brands. Novartis is the only company with leadership positions in
these areas. In 2006, the Group’s businesses achieved net
sales of USD 37.0 billion and net income of USD 7.2 billion.
Approximately USD 5.4 billion was invested in R&D.
Headquartered in Basel, Switzerland, Novartis Group companies
employ approximately 101,000 associates and operate in over 140
countries around the world. For more information, please visit
http://www.novartis.com.
Media Contacts
Megan Humphrey
Novartis Oncology
1-862-778-6724
Dana Kahn Cooper
Cooper Communications
1-732-239-6664
Posted: February 2007
