CHMP recommends Novartis drug Afinitor® for EU approval marking major milestone in the treatment of advanced breast cancer
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CHMP recommends Novartis drug Afinitor® for EU approval marking major milestone
in the treatment of advanced breast cancer
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* Upon approval, Afinitor will provide a new treatment approach for women with
HR+ advanced breast cancer, where there remains a significant unmet need[1]
* In a Phase III trial, women taking Afinitor with exemestane lived more than
twice as long without their cancer progressing compared to exemestane
alone[2]
* Worldwide regulatory submissions in HR+ advanced breast cancer are underway
and if approved, will represent the fifth indication for Afinitor, an mTOR
inhibitor
Basel, June 22, 2012 - Novartis announced today that the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted
a positive opinion for Afinitor(®) (everolimus) tablets*, in combination with
exemestane, for the treatment of hormone receptor-positive (HR+), HER2/neu-
negative (HER2-) advanced breast cancer, in postmenopausal women without
symptomatic visceral disease after recurrence or progression following a non-
steroidal aromatase inhibitor[1].
"Afinitor represents the first major innovation in HR+/HER2- advanced breast
cancer since aromatase inhibitors were introduced more than 15 years ago," said
Hervé Hoppenot, President, Novartis Oncology. "The Committee's support of
Afinitor brings us one step closer to providing an important new option for
women living with this disease."
The European Commission generally follows the recommendations of the CHMP and
usually delivers its final decision within three months of the CHMP
recommendation. The decision will be applicable to all 27 European Union member
states plus Iceland and Norway.
The CHMP opinion was based on pivotal Phase III data from the randomized,
double-blind, placebo-controlled, multi-center BOLERO-2 (Breast cancer trials of
OraL EveROlimus-2) trial[3]. The study evaluated 724 patients with HR+/HER2-
advanced breast cancer and found that treatment with Afinitor plus exemestane
more than doubled median progression-free survival (PFS) to 7.8 months, compared
to 3.2 months with exemestane alone (hazard ratio=0.45 [95% Cl: 0.38 to 0.54];
p<0.0001), by local investigator assessment[2]. An additional analysis based on
an independent central radiology review showed Afinitor extended median PFS to
11.0 months compared to 4.1 months (hazard ratio=0.38 [95% CI: 0.31 to 0.48];
p<0.0001)[2].
Each year, an estimated 220,000 women globally will be diagnosed with HR+/HER2-
advanced breast cancer[3]. Women with advanced breast cancer have a life
expectancy of approximately 18-36 months after diagnosis[4]. Endocrine therapy
remains the cornerstone of treatment for these women, but most will eventually
develop treatment resistance[5]. Therapeutic resistance has been associated with
overactivation of the PI3K/AKT/mTOR pathway[5]. Afinitor targets the mTOR
pathway in cancer cells. mTOR is a protein that acts as an important regulator
of tumor cell division, blood vessel growth and cell metabolism[5].
Afinitor is currently being considered in this patient population for approval
by the US Food and Drug Administration, the Swiss Agency for Therapeutic
Products (Swissmedic) and by health authorities worldwide. Afinitor is also
being studied in HER2-positive breast cancer in two Phase III trials.
About Advanced Breast Cancer
Hormone receptor-positive (HR+) advanced breast cancer is characterized by
hormone receptor tumors, a group of cancers that express receptors for certain
hormones such as estrogen and progesterone. Cancer cell growth is driven by
these hormones[6]. The presence of estrogen receptor (ER) and/or progesterone
receptor (PgR) is one of the most important predictive and prognostic markers in
human breast cancers, and is collectively referred to as HR+. Approximately 70
percent of all invasive breast cancers are positive for HR expressions at the
time of diagnosis[7].
Metastatic breast cancer, or stage IV breast cancer, is the most serious form of
the disease and occurs when the cancer has spread to other parts of the body
such as the bones or liver[6]. Advanced stage III breast cancer (also called
locally advanced) occurs when the cancer has spread to lymph nodes and/or other
tissue in the area of the breast and cannot be cured by surgery or radiation
treatment, but not to distant sites in the body[6].
About Afinitor (everolimus)
Afinitor(®) (everolimus) tablets is approved in more than 80 countries including
the United States and throughout the European Union in the oncology settings of
advanced renal cell carcinoma (RCC) following progression on or after vascular
endothelial growth factor (VEGF)-targeted therapy, and in the United States and
European Union for locally advanced, metastatic or unresectable progressive
neuroendocrine tumors of pancreatic origin (pNET).
Everolimus is also available from Novartis for use in non-oncology patient
populations under the brand names Afinitor(®) or Votubia(®), Certican(®) and
Zortress(®) and is exclusively licensed to Abbott and sublicensed to Boston
Scientific for use in drug-eluting stents.
Indications vary by country and not all indications are available in every
country. The safety and efficacy profile of everolimus has not yet been
established outside the approved indications. Because of the uncertainty of
clinical trials, there is no guarantee that everolimus will become commercially
available for additional indications anywhere else in the world.
Important Safety Information about Afinitor®
Afinitor(®)/Votubia(®) can cause serious side effects including lung or
breathing problems, infections, and renal failure, which can lead to death.
Mouth ulcers and mouth sores are common side effects. Afinitor/Votubia can
affect blood cell counts, kidney and liver function, and blood sugar and
cholesterol levels. Afinitor/Votubia may cause fetal harm in pregnant women.
Highly effective contraception is recommended for women of child-bearing
potential while receiving Afinitor/Votubia and for up to eight weeks after
ending treatment. Women taking Afinitor/Votubia should not breast feed.
The most common adverse drug reactions (incidence >=15 percent) are mouth
ulcers, diarrhea, feeling weak or tired, skin problems (such as rash or acne),
infections, nausea, swelling of extremities or other parts of the body, loss of
appetite, headache, inflammation of lung tissue, abnormal taste, nose bleeds,
inflammation of the lining of the digestive system, weight decreased and
vomiting. The most common Grade 3-4 adverse drug reactions (incidence >=2
percent) are mouth ulcers, feeling tired, low white blood cells (a type of blood
cell that fights infection), diarrhea, infections, inflammation of lung tissue,
diabetes and amenorrhea. Cases of hepatitis B reactivation and blood clots in
the lung and leg have been reported.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "recommends," "will," "underway," "positive opinion,"
"recommendations," "recommendation," "is currently being considered," or similar
expressions, or by express or implied discussions regarding potential
submissions or approvals for new indications or labeling for everolimus, or
regarding the timing of any such submission or approval, or regarding potential
future revenues from everolimus. You should not place undue reliance on these
statements. Such forward-looking statements reflect the current views of
management regarding future events, and involve known and unknown risks,
uncertainties and other factors that may cause actual results with everolimus to
be materially different from any future results, performance or achievements
expressed or implied by such statements. There can be no guarantee that
everolimus will be submitted or approved for any additional indications or
labeling in any market, or at any particular time. Nor can there be any
guarantee that everolimus will achieve any particular levels of revenue in the
future. In particular, management's expectations regarding everolimus could be
affected by, among other things, unexpected regulatory actions or delays or
government regulation generally; unexpected clinical trial results, including
unexpected new clinical data and unexpected additional analysis of existing
clinical data; the company's ability to obtain or maintain patent or other
proprietary intellectual property protection; government, industry and general
public pricing pressures; competition in general; unexpected manufacturing
issues; the impact that the foregoing factors could have on the values
attributed to the Novartis Group's assets and liabilities as recorded in the
Group's consolidated balance sheet; and other risks and factors referred to in
Novartis AG's current Form 20-F on file with the US 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.
About Novartis
Novartis provides innovative healthcare solutions that address the evolving
needs of patients and societies. Headquartered in Basel, Switzerland, Novartis
offers a diversified portfolio to best meet these needs: innovative medicines,
eye care, cost-saving generic pharmaceuticals, preventive vaccines and
diagnostic tools, over-the-counter and animal health products. Novartis is the
only global company with leading positions in these areas. In 2011, the Group's
continuing operations achieved net sales of USD 58.6 billion, while
approximately USD 9.6 billion (USD 9.2 billion excluding impairment and
amortization charges) was invested in R&D throughout the Group. Novartis Group
companies employ approximately 124,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visit http://www.novartis.com.
Novartis is on Twitter. Sign up to follow (at)Novartis at
http://twitter.com/novartis.
*Known as Votubia(®) (everolimus) tablets for certain patients with SEGA
associated with TSC in the EU and Switzerland.
References
[1] Novartis Data on File.
[2] Piccart M et al. Everolimus for Postmenopausal Women with Advanced Breast
Cancer: Updated Results of the BOLERO-2 Phase III Trial. Abstract #559.
American Society of Clinical Oncology 2012 Annual Meeting, Chicago, IL.
[3] Novartis Data on File.
[4] J. O'Shaughnessy. "Extending Survival with Chemotherapy in Metastatic
Breast Cancer." Oncology 2005, 10: 20-29.
[5] Baselga, J. Everolimus in Postmenopausal Hormone-Receptor-Positive
Advanced Breast Cancer. New England Journal of Medicine. February 9, 2012.
[6] National Cancer Institute. "What You Need to Know About Advanced Breast
Cancer." Available at:
http://www.cancer.gov/cancertopics/wyntk/breast/WYNTK_breast.pdf. Accessed
on March 8, 2012.
[7] Dobrescu, Andrei. "Study of Estrogen Receptor and Progesterone Receptor
Expression in Breast Ductal Carcinoma In Situ by Immunohistochemical
Staining in ER/PgR-Negative Invasive Breast Cancer." May 9, 2011.
Available at: http://www.isrn.com/journals/oncology/2011/673790/. Accessed
on April 9, 2012.
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Datum: 22.06.2012 - 13:35 Uhr
Sprache: Deutsch
News-ID 159136
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