Basel, Switzerland (ots/PRNewswire)
- New Treatment Option the First to Help Postmenopausal Women With
Early Breast Cancer Remain Cancer-Free Following Adjuvant Tamoxifen
Femara(R) (letrozole) is the first therapy approved by the U.S.
Food and Drug Administration (FDA) for the extended adjuvant
treatment of postmenopausal women with early breast cancer who have
received adjuvant (post-surgery) tamoxifen therapy for five years,
Novartis announced today.
"Femara truly provides hope to women who have survived early
breast cancer by offering them an improved chance of remaining
cancer-free," said Diane Young, M.D., vice president and global head
of Clinical Development at Novartis Oncology. "This priority review
approval marks the first time that nearly 100,000 women who complete
tamoxifen therapy each year will have a medical option to reduce
their ongoing risk of breast cancer recurrence."
The term extended adjuvant describes the period following adjuvant
(post- surgery) treatment with tamoxifen. Even years after breast
cancer diagnosis and primary treatment, the ongoing risk of breast
cancer recurrence remains significant for all patients. Globally,
approximately one-third of women with estrogen receptor-positive
early breast cancer experience a recurrence, and over half of those
recurrences occur more than five years after surgery. While tamoxifen
is beneficial for five years post surgery, if used beyond that
period, the risks associated with it outweigh the benefits. Extended
adjuvant treatment with Femara is the first therapy to effectively
reduce ongoing risk of breast cancer recurrence.
The approval for the extended adjuvant indication was based on
results from the landmark, international, independent MA-17 study,
which included more than 5,100 postmenopausal women and was
coordinated by the National Cancer Institute of Canada Clinical
Trials Group at Queens University in Kingston, Ontario, Canada, and
supported by Novartis. Initial results were published in the New
England Journal of Medicine in October 2003.
The study showed that Femara reduced the risk of cancer coming
back, or disease-free survival, by 38% and significantly increased a
woman's chance of staying cancer-free. This is particularly important
because when breast cancer recurs, it has very often spread beyond
the breast (metastatic disease), which can have serious consequences.
Femara also greatly reduced the chance of breast cancer returning to
another part of the body, or distant metastases, by 39%.
Femara is a leading once-a-day oral aromatase inhibitor that is
also indicated for first-line treatment of postmenopausal women with
hormone receptor-positive or hormone receptor-unknown locally
advanced or metastatic breast cancer and for the treatment of
advanced breast cancer in postmenopausal women with disease
progression following antiestrogen therapy, and as neo-adjuvant
(pre-operative) therapy. Not all indications are available in every
country. Novartis has filed in the European Union for the indication
of extended adjuvant treatment of early breast cancer in
postmenopausal women who have completed adjuvant (post-surgery)
tamoxifen therapy. In addition to the U.S., this indication is now
approved in the United Kingdom, Switzerland, Mexico, Korea and other
countries around the world. Femara is currently available in more
than 80 countries worldwide.
Femara contraindications and adverse events
The most common adverse events experienced with Femara are hot
flushes, arthralgia/arthritis and myalgia. Other commonly reported
adverse reactions are: nausea, fatigue, anorexia, appetite increase,
peripheral oedema, headache, dizziness, vomiting, dyspepsia,
constipation, diarrhea, alopecia, increased sweating, rash, myalgia,
bone pain, arthritis/arthralgia, and weight increase.
Femara is contraindicated in women who are pregnant or
breast-feeding as well as in women with premenopausal endocrine
hormone receptor status. Femara is contraindicated in patients with
known hypersensitivity to Femara or any of its excipients.
The foregoing release contains forward-looking statements that can
be identified by terminology such as "provides hope," "will have,"
"offering ... improved chance," or similar expressions, or by express
or implied discussions regarding potential future sales 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. In particular, management's expectations regarding
commercialization of Femara could be affected by, among other things,
additional analysis of Femara clinical data; new clinical data;
unexpected clinical trial results; unexpected regulatory actions or
delays or government regulation generally; the company's ability to
obtain or maintain patent or other proprietary intellectual property
protection; competition in general; increased government, industry,
and general public pricing pressures; 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.
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and
consumer health. In 2003, the Group's businesses achieved sales of
USD 24.9 billion and a net income of USD 5.0 billion. The Group
invested approximately USD 3.8 billion in R&D. Headquartered in
Basel, Switzerland, Novartis Group companies employ about 80,000
people and operate in over 140 countries around the world. For
further information please consult http://www.novartis.com
Additional information regarding Femara or Novartis Oncology can
be found on the websites www.femara.com
Additional media information can be found at
ots Originaltext: Novartis International AG
Im Internet recherchierbar: http://www.newsaktuell.ch
Contacts: John Gilardi Novartis Global Media Relations, Tel
+41-61-324-3018 (direct), or +41-79-596-1408 (mobile)
Kim Fox, Novartis Pharma
Communications, +1-862-778-7692 (direct) +1-917-415-2425 (mobile)