Novartis drug Afinitor® recommended by CHMP for EU approval to treat patients with advanced pancreatic neuroendocrine tumors
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Novartis drug Afinitor® recommended by CHMP for EU approval to treat patients
with advanced pancreatic neuroendocrine tumors
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* Phase III trial showed everolimus significantly delayed tumor growth in
patients with advanced neuroendocrine tumors (NET) of pancreatic origin [1]
* Everolimus represents a potentially new targeted approach for the treatment
of patients with advanced pancreatic NET, for which there are limited
options [1],[2],[3]
* Recommendation follows approval of Afinitor in the US in this setting;
additional regulatory submissions for everolimus in advanced NET are under
way worldwide
Basel, July 22, 2011 - Novartis announced today that the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a
positive opinion for Afinitor® (everolimus) tablets for the treatment of
unresectable or metastatic, well- or moderately-differentiated neuroendocrine
tumors (NET) of pancreatic origin in adults with progressive disease. If
approved, everolimus will be the first mTOR inhibitor available for these
patients.
"This positive recommendation is an important milestone for patients in the
European Union with advanced pancreatic NET who have a difficult to treat cancer
and limited treatment options," said Hervé Hoppenot, President, Novartis
Oncology. "We are encouraged that this positive opinion may lead to an approval
that will allow us to provide these patients a new targeted treatment approach."
The recommendation was based on Phase III data from the RADIANT-3 (RAD001 In
Advanced Neuroendocrine Tumors) trial showing treatment with everolimus more
than doubled the time without tumor growth (median 4.6 to 11.0 months) and
reduced the risk of cancer progression by 65% when compared with placebo in
patients with advanced pancreatic NET (hazard ratio=0.35 [95% confidence
interval (CI), 0.27 to 0.45]; p<0.001). A consistent improvement in progression-
free survival was seen with everolimus in all patient subgroups, including those
who had not received prior chemotherapy [1].
Everolimus targets mTOR, a protein that acts as an important regulator of tumor
cell division, blood vessel growth and cell metabolism [4]. Preclinical and
clinical data have established the role of mTOR in the development and
progression of advanced pancreatic NET [1],[4].
The European Commission generally follows the recommendations of the CHMP and
delivers its final decision within three months of the CHMP recommendation. The
decision will be applicable to all 27 EU member states plus Iceland and Norway.
About neuroendocrine tumors of pancreatic origin (pancreatic NET)
Neuroendocrine tumors arise from cells that can produce and secrete a variety of
hormones that regulate bodily functions [5]. These tumors can occur anywhere in
the body; however, most are found in the pancreas (pancreatic NET),
gastrointestinal tract or lungs (carcinoid tumors) [6],[7]. Pancreatic NET, also
known as islet cell tumors, is a rare type of cancer different from pancreatic
exocrine cancer, which is generally referred to as pancreatic cancer [3],[8].
Approximately 60% of pancreatic NET patients are diagnosed with advanced disease
[2]. This means that the cancer has already spread to other parts of the body,
and is considered aggressive and difficult to treat [3]. The five-year survival
rate for these patients is 27%[6].
About RADIANT-3
RADIANT-3 is a Phase III prospective, double-blind, randomized, parallel group,
placebo-controlled, multicenter study. The trial examined the efficacy and
safety of everolimus plus best supportive care (BSC) versus placebo plus BSC in
410 patients with advanced, low- or intermediate-grade pancreatic NET. Patients
who met the study entry criteria were randomized 1:1 to receive either
everolimus 10 mg once-daily (n=207) or daily placebo (n=203) orally, both in
conjunction with BSC. The primary endpoint is progression-free survival [1].
In the study, everolimus maintained a safety profile consistent with the
prescribing information and previous studies of the drug. The most frequent all
grade, drug-related adverse events (>=20%) were stomatitis/oral mucositis/ulcers
(64% everolimus vs. 17% placebo; includes stomatitis, aphthous stomatitis, mouth
ulceration and tongue ulceration), rash (49% vs. 10%), diarrhea (34% vs. 10%),
fatigue (31% vs. 14%), infections (23% vs. 6%), nausea (20% vs. 18%), peripheral
edema (20% vs. 3%) and decreased appetite (20% vs. 7%); most were grade one or
two. Grade three and four adverse events (>=5%) include stomatitis/oral
mucositis/ulcers (7% vs. 0%; includes stomatitis, aphthous stomatitis, mouth
ulceration and tongue ulceration), anemia (6% vs. 0%) and hyperglycemia (5% vs.
2%). Median exposure to everolimus was 2.3-fold longer than exposure to placebo
(38 weeks vs. 16 weeks)[1].
About Afinitor (everolimus)
Afinitor® (everolimus) tablets is approved in the US for the treatment of
progressive neuroendocrine tumors of pancreatic origin in patients with
unresectable, locally advanced or metastatic disease. The US Food and Drug
Administration determined that the safety and effectiveness of Afinitor in the
treatment of patients with carcinoid tumors have not been established.
In the European Union (EU), Afinitor is approved for the treatment of patients
with advanced renal cell carcinoma whose disease has progressed on or after
treatment with vascular endothelial growth factor (VEGF)-targeted therapy.
In the EU, everolimus is available in different dosage strengths for the non-
oncology patient population under the trade name Certican® for the prevention of
organ rejection in heart and kidney transplant recipients.
Everolimus is exclusively licensed to Abbott and sublicensed to Boston
Scientific for use in drug-eluting stents.
Not all indications are available in every country. Access to everolimus outside
of the approved indications has been carefully controlled and monitored in
clinical trials designed to better understand the potential benefits and risks
of the compound. As an investigational compound 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.
Important Safety Information about Afinitor (everolimus) tablets
Afinitor 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 can affect blood cell counts, kidney and
liver function, and blood sugar and cholesterol levels. Afinitor may cause fetal
harm in pregnant women. Women taking Afinitor should not breast feed.
The most common adverse drug reactions (incidence >=15%) 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%) are
mouth ulcers, feeling tired, low white blood cells (a type of blood cell that
fights infection), diarrhea, infections, inflammation of lung tissue, and
diabetes. Cases of hepatitis B reactivation and blood clot in the lung and leg
have been reported.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "recommended," "potentially," "recommendation," "under
way," "will," "milestone," "may," "potential," or similar expressions, or by
express or implied discussions regarding potential new indications or labeling
for everolimus 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 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; 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 healthcare solutions that address the evolving needs of
patients and societies. Focused solely on healthcare, Novartis offers a
diversified portfolio to best meet these needs: innovative medicines, eye care,
cost-saving generic pharmaceuticals, consumer health products, preventive
vaccines and diagnostic tools. Novartis is the only company with leading
positions in these areas. In 2010, the Group's continuing operations achieved
net sales of USD 50.6 billion, while approximately USD 9.1 billion (USD 8.1
billion excluding impairment and amortization charges) was invested in R&D
throughout the Group. Headquartered in Basel, Switzerland, Novartis Group
companies employ approximately 121,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visithttp://www.novartis.com.
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References
[1] Yao, et al. Everolimus for Advanced Pancreatic Neuroendocrine Tumors. New
Eng J Med 2011;364:514-23.
[2] Halfdanarson, et al. Pancreatic neuroendocrine tumors (PNETs): incidence,
prognosis and recent trend toward improved survival. Annals of Onc
19: 1727-1733, 2008.
[3] National Library of Medicine and the National Institutes of Health.
Pancreatic islet cell tumor. Available
athttp://www.nlm.nih.gov/medlineplus/ency/article/000393.htm. Accessed April
2011.
[4] Motzer, et. al. Phase 3 Trial of Everolimus for Metastatic Renal Cell
Carcinoma. Cancer 2010 Sep; 116(18):4256-4265.
[5] National Library of Medicine and the National Institutes of Health.
Neuroendocrine Tumor. Available athttp://www.cancer.gov/dictionary/?CdrID=44904.
Accessed April 2011.
[6] Yao, et al. One Hundred Years After "Carcinoid:" Epidemiology of and
Prognostic Factors for Neuroendocrine Tumors in 35,825 Cases in the United
States. Journal of Clinical Oncology. June 20 2009; vol. 26, number 18.
[7] American Cancer Society Detailed Guides. Gastrointestinal Carcinoid Tumors.
Available athttp://www.cancer.org/acs/groups/cid/documents/webcontent/003102-
pdf.pdf. Accessed April 2011.
[8] American Cancer Society Detailed Guides. Pancreatic Cancer. Available
athttp://www.cancer.org/acs/groups/cid/documents/webcontent/003131-pdf.pdf.
Accessed April 2011.
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Datum: 22.07.2011 - 15:15 Uhr
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News-ID 56641
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