Afinitor® recommended for use in the European Union for patients with
advanced kidney cancer
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* Afinitor more than doubled time without tumor growth and reduced
the risk of disease progression or death by 67% compared with
placebo
* Only treatment shown to benefit patients with advanced kidney
cancer whose disease progressed following targeted therapy
* CHMP opinion follows recent US approval of Afinitor in advanced
kidney cancer
* Phase III trials underway to explore potential in multiple
additional cancers
Basel, May 29, 2009 - Novartis has received a positive opinion from
the Committee for Medicinal Products for Human Use (CHMP) supporting
European Union (EU) approval of Afinitor® (everolimus) Tablets for
the treatment of patients with advanced renal cell carcinoma
(RCC)[1].
The CHMP has recommended approval of Afinitor based on data
demonstrating that when compared with placebo, Afinitor more than
doubled the time without tumor growth or death in patients with
advanced kidney cancer (4.9 vs. 1.9 months) whose disease progressed
following prior therapy[1],[2]. Additionally, the data showed
Afinitor reduced the risk of disease progression or death by 67%
(hazard ratio=0.33 with 95% confidence interval 0.25 to 0.43;
P<0.0001)[2].
The European Commission generally follows the recommendations of the
CHMP and delivers its final decision within two to three months. The
decision will apply in all 27 EU member states. Regulatory reviews of
Afinitor are underway in Switzerland, Japan and other countries[1].
"This positive opinion is good news for those living with advanced
kidney cancer and puts us one step closer to offering these patients
a new treatment choice that will fulfill an important unmet medical
need," said David Epstein, President and CEO, Novartis Oncology,
Novartis Molecular Diagnostics. "We also are studying the role of
Afinitor for early kidney cancer, as well as its potential as a
treatment for other tumor types."
In March 2009, the US Food and Drug Administration (FDA) approved
Afinitor for use in patients with advanced RCC after failure of
treatment with sunitinib or sorafenib, following a priority review of
Afinitor based on its potential to fill an unmet medical need for
these patients[1],[2]. Sunitinib and sorafenib are VEGF-targeted
therapies, commonly used as initial treatments for advanced RCC[1].
Filing data
The EU regulatory filing for Afinitor was based on data from RECORD-1
(REnal Cell cancer treatment with Oral RAD001 given Daily), the
largest Phase III clinical trial to study the effects of an oral mTOR
inhibitor in advanced RCC patients whose cancer progressed despite
prior treatment. In February 2008, based on a recommendation from an
independent data monitoring committee, Novartis stopped the trial
after interim results showed that patients receiving Afinitor
experienced a significant delay in cancer progressing or death
compared with patients receiving placebo[1],[2].
This international, multicenter, randomized, double-blind trial
involved 416 patients with advanced RCC whose cancer progressed
despite prior treatment with sunitinib or sorafenib. In addition,
prior therapy with bevacizumab, interferon alfa and interleukin-2 was
allowed. Patients were randomized to receive Afinitor (10 mg) daily
or placebo, in conjunction with best supportive care. The primary
endpoint of the study was progression-free survival, which was
assessed via a blinded independent, central radiological review[2].
About RCC
RCC, which accounts for approximately 2% of all new cancers, is often
referred to as kidney cancer. The occurrence rates of RCC are rising
steadily around the world due in part to smoking and obesity[3].
In RCC, cancer cells develop in the lining of the kidney's tubes and
grow into a tumor[4]. If left untreated, the tumor can spread to
neighboring lymph nodes and eventually to other organs[5].
About Afinitor
Afinitor is approved in the US as the first oral, daily therapy (5 mg
and 10 mg tablets) to treat patients with advanced RCC after failure
of treatment with sunitinib or sorafenib[1],[2]. Afinitor works by
directly targeting mTOR, a protein in the cancer cell that controls
tumor cell division and blood vessel growth. Preclinical and clinical
data have established the important role of mTOR in the development
and progression of several types of tumors. Afinitor is also being
studied in multiple cancer types, including neuroendocrine, breast,
gastric and hepatocellular carcinoma (HCC), as well as tuberous
sclerosis complex (TSC) and non-Hodgkin's lymphoma[1].
The active ingredient in Afinitor is everolimus, which is available
in different dosage strengths under the trade name Certican® for the
prevention of organ rejection in heart and kidney transplant
recipients. Certican was first approved in the EU in 2003[1].
Important safety information
Afinitor is contraindicated in patients with hypersensitivity to
everolimus, to other rapamycin derivatives or to any of the
excipients. Potentially serious adverse reactions include
non-infectious pneumonitis and infections for which patients should
be monitored carefully and treated as needed. In addition,
non-infectious pneumonitis may require temporary dose reduction
and/or interruption or discontinuation. Patients with systemic
invasive fungal infections should not receive Afinitor. Oral
ulceration is a common side effect with Afinitor. Renal function,
blood glucose, lipids and hematological parameters should be
evaluated prior to the start of therapy with Afinitor and
periodically thereafter. Strong or moderate CYP3A4 or P-glycoprotein
inhibitors should be avoided. An increase in the dose of Afinitor is
recommended when co-administered with a strong CYP3A4 inducer. Live
vaccinations and close contact with those who have received live
vaccines should be avoided by patients taking Afinitor. Afinitor
should not be used in patients with severe hepatic impairment.
Afinitor may cause fetal harm in pregnant women.
The most common adverse reactions irrespective of causality
(incidence >=30%) were stomatitis, infections, asthenia, fatigue,
cough and diarrhea. The most common grade 3/4 adverse reactions
irrespective of causality (incidence >=3%) were infections, dyspnea,
fatigue, stomatitis, dehydration, pneumonitis, abdominal pain and
asthenia. The most common laboratory abnormalities (incidence >=50%)
were anemia, hypercholesterolemia, hypertriglyceridemia,
hyperglycemia, lymphopenia and increased creatinine. The most common
grade 3/4 laboratory abnormalities (incidence >=3%) were lymphopenia,
hyperglycemia, anemia, hypophosphatemia and hypercholesterolemia.
Deaths due to acute respiratory failure (0.7%), infection (0.7%) and
acute renal failure (0.4%) were observed in patients receiving
Afinitor.
Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "recommended," "risk," "potential,"
"generally follows the recommendations of the CHMP and delivers .,"
"will," "can," or similar expressions, or by express or implied
discussions regarding potential new indications or labeling for
Afinitor, potential approvals of Afinitor in additional markets, or
regarding potential future revenues from Afinitor. 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 Afinitor to be materially
different from any future results, performance or achievements
expressed or implied by such statements. There can be no guarantee
that Afinitor will be approved for sale in any additional markets.
Neither can there be any guarantee that Afinitor will be approved for
any additional indications or labeling in any market. Nor can there
be any guarantee that Afinitor will achieve any particular levels of
revenue in the future. In particular, management's expectations
regarding Afinitor 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; competition in
general; government, industry and general public pricing pressures;
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 AG 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, cost-saving generic pharmaceuticals, preventive
vaccines, diagnostic tools and consumer health products. Novartis is
the only company with leading positions in these areas. In 2008, the
Group's continuing operations achieved net sales of USD 41.5 billion
and net income of USD 8.2 billion. Approximately USD 7.2 billion was
invested in R&D activities throughout the Group. Headquartered in
Basel, Switzerland, Novartis Group companies employ approximately
98,000 full-time-equivalent associates and operate in more than 140
countries around the world. For more information, please visit
http://www.novartis.com.
References
[1] Novartis data on file.
[2] Afinitor Prescribing Information.
[3] Eisen, et al. Sorafenib for Older Patients With Renal Cell
Carcinoma: Subset Analysis From a Randomized Trial. Journal of the
National Cancer Institute. 2008; 100(20):1454-1463.
[4] National Cancer Institute. General Information About Renal Cell
Cancer. Available at:
http://www.cancer.gov/cancertopics/pdq/treatment/renalcell/patient.
Accessed April 2009.
[5] National Cancer Institute. Stages of Renal Cell Cancer. Available
at:
http://www.cancer.gov/cancertopics/pdq/treatment/renalcell/Patient/page2.
Accessed April 2009.
# # #
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