Bli medlem
Bli medlem

Du är här


Novartis International AG: Novartis drug Afinitor® extended progression-free survival in Phase III trial in advanced gastrointestinal or lung neuroendocrine t

Novartis International AG / Novartis drug Afinitor® extended progression-free
survival in Phase III trial inadvanced gastrointestinal or lung
neuroendocrine tumors . Processed and transmitted by NASDAQ OMX Corporate
Solutions.The issuer is solely responsible for the content of this
* Study in patients with advanced nonfunctional neuroendocrine tumors (NET)
of gastrointestinal (GI) or lung origin met primary endpoint[1]
* Full results will be submitted for presentation at a major medical meeting;
worldwide regulatory filings are planned for 2015
* Afinitor is already approved in more than 95 countries for patients with
advanced pancreatic NET, a rare form of cancer[1],[2],[3]

Basel, May 21, 2015
Novartis announced today that the Phase III study of Afinitor®(everolimus)
tablets plus best supportive care in patients with advanced nonfunctional
neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin met its
primary endpoint: significant extension of progression-free survival (PFS)
compared to placebo plus best supportive care[1]. The RADIANT-4 study is part
of one of the largest clinical trial programs in NET[1].

NET are a rare type of cancer that originate in neuroendocrine cells found
throughout the body, and are most often found in the GI tract, lungs or
pancreas[4]. NET can be functional or nonfunctional: functional NET produce
symptoms caused by the secretion of hormones and other substances;
nonfunctional NET do not secrete hormones, and may only produce symptoms
caused by the tumor's growth, such as intestinal blockage, pain and
bleeding[5],[6],[7]. At time of diagnosis, up to 44% of patients with GI NET
and 28% of patients with lung NET have advanced disease, meaning the cancer
has spread to other parts of the body and is more difficult to
treat[2],[3],[4]. There are limited treatment options for patients with
advanced GI or lung NET[4].

"We look forward to presenting the findings from the RADIANT-4 trial of
everolimus, which has the potential to become an important treatment option
for patients with advanced nonfunctional GI or lung NET," said Alessandro
Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs.
"The results will serve as the basis of planned worldwide regulatory filings
for everolimus in these two types of NET, bringing us closer to our goal of
offering Afinitor for these patients."

Full results from the RADIANT-4 study will be submitted to a major medical
meeting. Worldwide regulatory filings are planned for 2015.


RADIANT-4 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 versus placebo plus best
supportive care in 302 patients with well differentiated advanced NET of GI
or lung origin, and no history or active symptoms of carcinoid syndrome, who
had documented disease progression within the previous 6 months. Patients
were randomized 2:1 to receive either daily everolimus 10 mg or daily placebo

The primary endpoint of RADIANT-4 was PFS. Secondary endpoints included
safety, objective response rate and overall survival.

About Afinitor®
(everolimus) tablets

(everolimus) is approved in more than 95 countries, including the United
States and throughout the European Union, for locally advanced, metastatic or
unresectable progressive neuroendocrine tumors of pancreatic origin. It is
also approved in 119 countries including the United States and European Union
for advanced renal cell carcinoma following progression on or after vascular
endothelial growth factor (VEGF)-targeted therapy.

Afinitor is approved in the European Union for the treatment of hormone
receptor-positive, human epidermal growth factor receptor-2 negative
(HR+/HER2-) advanced breast cancer, in combination with exemestane, in
postmenopausal women without symptomatic visceral disease after recurrence or
progression following a non-steroidal aromatase inhibitor (NSAI). In the
United States, Afinitor is approved for the treatment of postmenopausal women
with advanced hormone receptor-positive, HER2 negative (advanced HR+/HER2-)
breast cancer in combination with exemestane after failure of treatment with
letrozole or anastrozole.

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 mouth
ulcers, skin rash, feeling tired or weak, diarrhea, absence of menstrual
periods, infections (including upper respiratory tract infection, sore throat
and runny nose, sinusitis, and pneumonia), nausea, decreased appetite, low
level of red blood cells, high levels of cholesterol, abnormal taste, acne,
irregular menstrual periods, inflammation of lung tissue, high level of blood
sugar, weight loss, itching, swelling of extremities or other parts of the
body, nose bleeds, and headache. The most common Grade 3-4 adverse drug
reactions (incidence>=2 percent) are mouth ulcers, absence of menstrual
periods, low level of red blood cells, infections (including pneumonia), high
level of blood sugar, feeling tired or weak, low white blood cells,
inflammation of lung tissue, diarrhea, 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.


The foregoing release contains forward-looking statements that can be
identified by words such as "will," "planned," "can," "look forward,"
"potential," "goal," "plan," "yet," or similar terms, or by express or
implied discussions regarding 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 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 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 2014, the Group
achieved net sales of USD 58.0 billion, while R&D throughout the Group
amounted to approximately USD 9.9 billion (USD 9.6 billion excluding
impairment and amortization charges). Novartis Group companies employ
approximately 120,000 full-time-equivalent associates. Novartis products are
available in more than 180 countries around the world. For more information,
please visit

Novartis is on Twitter. Sign up to follow @Novartis


[1] Novartis data on file.
[2] National Library of Medicine and the National Institutes of Health.
Pancreatic islet cell tumor. Available
at Accessed May

[3] Halfdanarson, et al. Pancreatic neuroendocrine tumors (PNETs): incidence,
prognosis and recent trend toward improved survival. Annals of Onc. 2008; 19:
[4] Yao, 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] Akerstrom, et al. Timing and extent of surgery in symptomatic and
asymptomatic neuroendocrine tumors of the pancreas in MEN 1. Langenbecks Arch
Surg. 2002; 386:558-69.
[6] Modlin, et al. Priorities for Improving the Management of
Gasteroenteropancreatic Neuroendocrine Tumors. J Natl Cancer Inst 2008;100:
[7] Oberg K, Kvols L, Caplin M, et al. Consensus report on the use of
somatostatin analogs for t...

Författare Hugin

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.