Novartis drug Afinitor® receives EU approval to treat certain types of advanced gastrointestinal (GI) and lung neuroendocrine tumors (NET)
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Novartis International AG /
Novartis drug Afinitor® receives EU approval to treat certain types of advanced
gastrointestinal (GI) and lung neuroendocrine tumors (NET)
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The issuer is solely responsible for the content of this announcement.
* Afinitor fills critical need in EU as first approved therapy for advanced,
progressive, nonfunctional lung NET and first oral therapy for this type of
GI NET
* Nonfunctional GI and lung NET are rare cancers often diagnosed at advanced
stages and associated with poor prognoses[1],[2]
* Afinitor is now approved in EU to treat three most common types of advanced
NET[3],[4]
The digital press release with multimedia content can be accessed here:
Basel, June 2, 2016 - Novartis announced today that the European Commission has
approved Afinitor(®) (everolimus) tablets for the treatment of unresectable or
metastatic, well-differentiated (Grade 1 or Grade 2) nonfunctional
neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin in adults
with progressive disease. Afinitor is the first approved therapy in all 28
member states of the European Union (EU), plus Iceland and Norway, for this type
of lung NET, and one of very few treatment options available for this type of GI
NET.
"With this decision, Afinitor is now approved in the EU to treat the three most
common types of advanced NET," said Bruno Strigini, President, Novartis
Oncology. "As a company that has long been dedicated to advancing care for NET
patients, we are pleased that this latest milestone makes Afinitor available to
patients in the EU who previously had few or no approved treatment options."
Neuroendocrine tumors are a type of cancer that originate in neuroendocrine
cells throughout the body, and most commonly arise in the GI tract, lungs or
pancreas[1],[4]. NET can be defined as functional or nonfunctional[5]. The
majority of patients with NET (72%) have nonfunctional NET, which are
characterized by symptoms caused by tumor growth, such as intestinal
obstruction, pain and bleeding for GI NET, and asthma, chronic obstructive
pulmonary disease and pneumonia for lung NET[5],[6],[7],[8],[9]. In contrast,
functional NET are characterized by symptoms caused by the oversecretion of
hormones and other substances[5]. Five to 44% (depending on site of tumor
origin) of those with GI NET and 28% of those with lung NET have advanced
disease at time of diagnosis, meaning the cancer has spread to other areas of
the body, and patients face limited treatment options[1],[4]. Progression, or
the continued growth or spread of the tumor, is typically associated with poor
prognoses[10].
The EU approval of Afinitor was based on efficacy and safety data from a pivotal
Phase III study (RADIANT-4) evaluating Afinitor versus placebo in patients with
advanced, progressive, well-differentiated nonfunctional NET of GI or lung
origin. Results showed that Afinitor reduced the risk of disease progression by
52% (hazard ratio = 0.48; 95% confidence interval [CI], 0.35-0.67; p<0.00001)
compared to placebo. The data also showed Afinitor increased median progression-
free survival (PFS) by 7.1 months: median PFS by central review was 11.0 months
(95% CI, 9.2-13.3) in the Afinitor arm and 3.9 months (95% CI, 3.6-7.4) in the
placebo arm[3].
In the pivotal trial, the most common treatment-related, all-grade adverse
events (AEs) (incidence >=20%) for Afinitor and placebo, respectively, were
stomatitis (63% vs 19%), diarrhea (31% vs 16%), fatigue (31% vs 24%), infections
(29% vs 4%), rash (27% vs 8%) and peripheral edema (26% vs 4%). The most common
treatment-related grade 3/4 AEs (incidence >=5%) for Afinitor versus placebo
were stomatitis (9.0% vs 0.0%), diarrhea (7.0% vs 2.0%) and infections (7.0% vs
0.0%)[3].
In February 2016, the US Food and Drug Administration approved Afinitor for the
treatment of adult patients with progressive, well-differentiated nonfunctional
NET of GI or lung origin that are unresectable, locally advanced or metastatic.
In April 2016, the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) adopted a positive opinion for Afinitor tablets
for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or
Grade 2) nonfunctional NET of GI or lung origin in adults with progressive
disease. Afinitor received approval for this indication in Canada in May 2016,
and additional worldwide regulatory filings are underway.
About RADIANT-4 Study: Part of the largest clinical trial program in advanced
NET
RADIANT-4 (RAD001 In Advanced Neuroendocrine Tumors) is a Phase III prospective,
double-blind, randomized, parallel group, placebo-controlled, multicenter study.
It examined the efficacy and safety of Afinitor plus best supportive care (BSC)
vs placebo plus BSC in 302 patients with unresectable, progressive, well-
differentiated nonfunctional, locally advanced or metastatic NET of GI
(excluding pancreatic) or lung origin. The primary endpoint of RADIANT-4 was PFS
based on independent radiological assessment evaluated by Response Evaluation
Criteria in Solid Tumors. Secondary endpoints included overall survival and best
overall response rate (defined as complete response plus partial response)[3].
Patients were randomized 2:1 to receive a daily dose of Afinitor 10 mg or
placebo (supplied as tablets). During treatment, all patients received BSC,
which excluded somatostatin analogues (SSAs). Patients had low or intermediate
grade histology, no history or active symptoms of carcinoid syndrome, and
documented disease progression within the previous 6 months, and were required
to have stopped treatment with SSAs for 4 weeks before study entry[3],[11].
The safety profile of Afinitor was consistent with what has been observed in
previous studies of this drug[3].
About Afinitor(®) (everolimus) tablets
Afinitor (everolimus) tablets is approved in in more than 110 countries,
including the US and in the European Union, for locally advanced, metastatic or
unresectable progressive NET of pancreatic origin. Afinitor is not indicated for
the treatment of patients with functional carcinoid tumors in the US. Afinitor
is now also approved in the US and EU for the treatment of adult patients with
progressive, well-differentiated (Grade 1 or Grade 2), nonfunctional
neuroendocrine tumors of gastrointestinal or lung origin that are unresectable,
locally advanced or metastatic.
It is also approved in more than 120 countries including the US and European
Union for advanced renal cell carcinoma following progression on or after
vascular endothelial growth factor (VEGF)-targeted therapy (in the US,
specifically following sunitinib and sorafenib).
Additionally, Afinitor is approved in more than 110 countries including the
United States and European Union for advanced HR+/HER2- breast cancer in
combination with
exemestane, after prior endocrine therapy.
Everolimus is also available from Novartis for use in certain 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(®) (everolimus) tablets
Afinitor/Votubia can cause serious side effects including lung or breathing
problems, infections (including sepsis), and kidney failure, which can lead to
death. Patients taking concomitant angiotensin-converting enzyme (ACE)
inhibitors may be at an increased risk for angioedema. Mouth ulcers and mouth
sores are common side effects. Afinitor/Votubia can affect blood cell counts,
kidney and liver function, and blood sugar, cholesterol, and triglyceride
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. Fertility in
women and men may be affected by treatment with Afinitor/Votubia.
The most common adverse drug reactions (incidence >=10 percent) are infections
(including sore throat and runny nose, upper respiratory tract infection,
pneumonia, sinusitis, and urinary tract infection), mouth ulcers, skin rash,
feeling tired, diarrhea, fever, vomiting, nausea, cough, decreased appetite, low
level of red blood cells, headache, abnormal taste, absence of menstrual
periods, acne, inflammation of lung tissue, irregular menstrual periods,
swelling of extremities or other parts of the body, high level of blood sugar,
feeling weak, itching, weight loss, high levels of cholesterol, and nose
bleeds. The most common Grade 3-4 adverse drug reactions (incidence >=2
percent) are mouth ulcers, infections (including pneumonia), low level of red
blood cells, high level of blood sugar, feeling tired, absence of menstrual
periods, diarrhea, low white blood cells, inflammation of lung tissue, feeling
weak, fever, and spontaneous bleeding or bruising. Cases of hepatitis B
reactivation, blood clots in the lung or legs, and pneumocystis jirovecii
pneumonia (PJP) have been reported. Abnormalities were observed in hematology
and clinical chemistry laboratory tests.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "dedicated," "positive opinion," "underway," "yet," "will," or
similar terms, or by express or implied discussions regarding potential new
marketing approvals for Afinitor (everolimus), potential new indications or
labeling for Afinitor, or regarding potential future revenues from Afinitor. You
should not place undue reliance on these statements. Such forward-looking
statements are based on the current beliefs and expectations of management
regarding future events, and are subject to significant known and unknown risks
and uncertainties. Should one or more of these risks or uncertainties
materialize, or should underlying assumptions prove incorrect, actual results
may vary materially from those set forth in the forward-looking statements.
There can be no guarantee that Afinitor will be submitted or approved for sale
in any additional markets, or at any particular time. Neither can there be any
guarantee that Afinitor 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 Afinitor will be commercially successful in the future. In
particular, management's expectations regarding Afinitor could be affected by,
among other things, the uncertainties inherent in research and development,
including unexpected clinical trial results and additional analysis of existing
clinical data; unexpected regulatory actions or delays or government regulation
generally; the company's ability to obtain or maintain proprietary intellectual
property protection; general economic and industry conditions; global trends
toward health care cost containment, including ongoing pricing pressures;
unexpected safety, quality or manufacturing issues, and other risks and factors
referred to in Novartis AG's current Form 20-F on file with the US Securities
and Exchange Commission. 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 and cost-saving generic pharmaceuticals. Novartis is the only global
company with leading positions in these areas. In 2015, the Group achieved net
sales of USD 49.4 billion, while R&D throughout the Group amounted to
approximately USD 8.9 billion (USD 8.7 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately 118,000
full-time-equivalent associates. Novartis products are available in more than
180 countries around the world. For more information, please visit
http://www.novartis.com.
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References
[1] American Cancer Society. Gastrointestinal Carcinoid Tumors. Available at
http://www.cancer.org/acs/groups/cid/documents/webcontent/003102-pdf.pdf.
Accessed May 2016.
[2] American Cancer Society. Lung Carcinoid Tumors. Available at
http://www.cancer.org/acs/groups/cid/documents/webcontent/003117-pdf.pdf.
Accessed May 2016.
[3] Afinitor Summary of Product Characteristics.
[4] Yao J, et al. One hundred years after "Carcinoid:" Epidemiology of and
prognostic factors for neuroendocrine tumors in 35,825 cases in the
United States. J Clin Oncol. 2008; 26: 3063-72.
[5] Öberg K, et al. Gastrointestinal neuroendocrine tumors. Annals of
Oncology. 2010; 21: vii72-vii80.
[6] Choti M.A., et al. Prevalence of functional tumors in neuroendocrine
carcinoma: An analysis from the National Comprehensive Cancer Network
Neuroendocrine Tumors database. The North American Neuroendocrine Tumor
Society (NANETS) Symposium. October 2012, San Diego, US.
[7] Modlin I, et al. Priorities for improving the management of
gastroenteropancreatic neuroendocrine tumors. J Natl Cancer Inst.
2008; 100: 1282-1289.
[8] Modlin I, et al. Current status of gastrointestinal carcinoids.
Gastroenterology. 2005; 128: 1717-1751.
[9] Wolin EM. Challenges in the diagnosis and management of well-
differentiated neuroendocrine tumors of the lung (typical and atypical
carcinoid): Current status and future considerations. The Oncologist.
2015; 20:1123-1131.
[10] National Cancer Institute. "NCI Dictionary of Cancer Terms." Available at
http://www.cancer.gov/publications/dictionaries/cancer-terms. Accessed
May 2016.
[11] Yao J, et al. Everolimus for the treatment of advanced, non-functional
neuroendocrine tumours of the lung or gastrointestinal tract (RADIANT-
4): a randomised, placebo-controlled, phase 3 study. The Lancet.
2016; 387 (10022): 968-977.
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Datum: 02.06.2016 - 07:15 Uhr
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News-ID 475207
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