Novartis LEE011 (ribociclib) granted FDA Priority Review for first-line treatment of HR+/HER2- advanced breast cancer
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Novartis International AG /
Novartis LEE011 (ribociclib) granted FDA Priority Review for first-line
treatment of HR+/HER2- advanced breast cancer
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The issuer is solely responsible for the content of this announcement.
* Priority Review based on Phase III MONALEESA-2 trial, which showed LEE011
plus letrozole, as initial treatment for advanced breast cancer,
significantly extended progression-free survival compared to letrozole
alone[1]
* Underscores potential of LEE011 plus letrozole as a new treatment option for
advanced breast cancer; may lead to faster access for US patients
* A marketing authorization application for LEE011 plus letrozole has also
been accepted for review by the European Medicines Agency (EMA)
Basel, November 1, 2016 - Novartis announced today that the US Food and Drug
Administration (FDA) accepted the company's New Drug Application (NDA) for
filing and granted Priority Review for LEE011 (ribociclib) as first-line
treatment of postmenopausal women with hormone-receptor positive, human
epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic
breast cancer in combination with letrozole. The NDA is based on a comprehensive
clinical package, including results of the Phase III MONALEESA-2 trial. The
trial, which was presented at the European Society for Medical Oncology (ESMO)
2016 Congress and published simultaneously in the New England Journal of
Medicine, showed LEE011 plus letrozole reduced the risk of progression or death
by 44% (HR = 0.556, 95% CI: 0.429-0.720; P = 0.00000329) over letrozole alone,
significantly extending progression-free survival (PFS) across all patient
subgroups[1]. The company also announced that the EMA has accepted for review
the marketing authorization application for LEE011 plus letrozole in the same
patient population.
"These regulatory milestones, along with the FDA Breakthrough Therapy
designation granted in August, underscore the need for new treatment options for
women living with HR+/HER2- advanced breast cancer," said Bruno Strigini, CEO,
Novartis Oncology. "Priority Review allows a shorter review period compared with
FDA standard review in the US, helping us to potentially bring LEE011 plus
letrozole to patients more quickly. We also are working diligently with the EMA
and other Health Authorities to bring this treatment to patients around the
world as fast as possible."
FDA Priority Review designation requires the agency to take action on an
application within six months of its filing date compared to ten months under
standard review[2]. FDA grants Priority Review to applications for new drug
candidates that treat serious conditions, such as advanced breast cancer for
which there is currently no cure, and if approved, would provide a significant
improvement in treatment safety or efficacy[2].
About LEE011 (ribociclib)
LEE011 (ribociclib) is a selective cyclin dependent kinase inhibitor, a class of
drugs that help slow the progression of cancer by inhibiting two proteins called
cyclin dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated in
a cell, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6
with enhanced precision may play a role in ensuring cancer cells do not grow
uncontrollably.
LEE011 is not approved for any indication in any market at this time. LEE011 was
developed by the Novartis Institutes for BioMedical Research (NIBR) under a
research collaboration with Astex Pharmaceuticals.
About the MONALEESA Clinical Trial Program
Novartis is continuing to assess LEE011 through the robust MONALEESA (Mammary
ONcology Assessment of LEE011's Efficacy and SAfety) clinical trial program,
which includes MONALEESA-2, MONALEESA-3, and MONALEESA-7. These trials are
evaluating LEE011 in multiple endocrine therapy combinations across a broad
range of patients, including men and premenopausal women.
MONALEESA-2 is a Phase III randomized, double blind, placebo controlled,
multicenter global registration trial to evaluate the safety and efficacy of
LEE011 in combination with letrozole compared to letrozole alone in
postmenopausal women with HR+/HER2- advanced breast cancer who received no prior
therapy for their advanced breast cancer[1].
The trial randomized 668 patients in a 1:1 ratio stratified by the presence of
liver and/or lung metastases at 223 clinical trial sites globally[1]. Patients
received LEE011 600 mg/daily (three weeks on and one week off), or placebo, in
combination with letrozole 2.5 mg/daily.
The primary endpoint of the trial was PFS[1]. Secondary endpoints included:
overall survival, overall response rate, clinical benefit rate, health-related
quality of life, safety and tolerability[1].
The MONALEESA-3 trial is evaluating LEE011 in combination with fulvestrant
compared to fulvestrant alone in men and post-menopausal women with HR+/HER2-
advanced breast cancer who have received no or a maximum of one prior endocrine
therapy.
The MONALEESA-7 trial is investigating LEE011 in combination with endocrine
therapy and goserelin compared to endocrine therapy and goserelin alone in pre-
menopausal women with HR+/HER2- advanced breast cancer who have not previously
received endocrine therapy. Both MONALEESA-3 and MONALEESA-7 are fully enrolled.
About Advanced Breast Cancer
Up to one-third of patients with early-stage breast cancer will subsequently
develop metastatic disease[3]. Metastatic 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 brain, bones or liver[4]. Advanced breast cancer comprises
metastatic breast cancer (stage 4) and locally advanced breast cancer (stage
3)[4]. Survival rates for women living with advanced breast cancer are lower
than those for women with earlier stage disease. The 5-year relative survival
rate for stage 3 breast cancer is approximately 72%, while metastatic (stage 4)
breast cancer has a 5-year relative survival rate of approximately 22%[5].
About Novartis in Advanced Breast Cancer
For more than 25 years, Novartis has been at the forefront of driving scientific
advancements for breast cancer patients and improving clinical practice in
collaboration with the global community[6]. With one of the most diverse breast
cancer pipelines and the largest number of breast cancer compounds in
development, Novartis leads the industry in discovery of new therapies and
combinations, especially in HR+ advanced breast cancer, the most common form of
the disease[6].
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "Priority Review," "potential," "may," "Breakthrough Therapy
designation," "potentially," "would," "continuing," "evaluating,"
"investigating," "will," "pipelines," or similar terms, or by express or implied
discussions regarding potential marketing approvals for LEE011, or regarding
potential future revenues from LEE011 or other products in the Novartis breast
cancer pipeline. 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 LEE011 will be submitted or approved
for sale in any market, or at any particular time. Nor can there be any
guarantee that LEE011 or any other product in the Novartis breast cancer
pipeline will be commercially successful in the future. In particular,
management's expectations regarding LEE011 and the other products in the
Novartis breast cancer pipeline 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; competition in general;
global trends toward health care cost containment, including ongoing pricing
pressures; unexpected manufacturing, safety or quality 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] Hortobagyi G, Stemmer S, Burris H, et al. First-line ribociclib plus
letrozole for postmenopausal women with HR+, HER2-, advanced breast cancer:
First results from the Phase III MONALEESA-2 study. Presented at the European
Society for Medical Oncology (ESMO) Congress, October 8, 2016, Copenhagen,
Denmark (abstract # LBA1_PR)
[2] FDA. Priority Review. Available at
http://www.fda.gov/forpatients/approvals/fast/ucm405405.htm. Accessed October
19, 2016.
[3] O'Shaughnessy J. Extending survival with chemotherapy in metastatic breast
cancer. The Oncologist. 2005;10 (Suppl 3):20-29.
[4] American Cancer Society. How do you determine the stage of breast cancer?
Available at http://www.cancer.org/cancer/breastcancer/detailedguide/breast-
cancer-staging. Accessed May 10, 2016.
[5] American Cancer Society. Breast cancer survival rates, by stage. Available
at http://www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-
survival-by-stage. Accessed July 7, 2016.
[6] Novartis Data on File
# # #
Novartis Media Relations
Central media line: +41 61 324 2200
E-mail: media.relations(at)novartis.com
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Novartis Global Media Relations Novartis Oncology Media Relations
+41 61 324 7999 (direct) +1 862 778 7220 (direct)
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Source: Novartis International AG via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 01.11.2016 - 07:15 Uhr
Sprache: Deutsch
News-ID 503944
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contact information:
Town:
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Kategorie:
Business News
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