-
CHMP opinion based on
pivotal Phase III trial that showed Kisqali plus letrozole reduced
risk of disease progression or death by 44% over letrozole alone
among postmenopausal women with HR+/HER2- advanced breast
cancer[1]
-
After nearly one year of
additional follow-up, Kisqali plus letrozole demonstrated median
progression-free survival (PFS) of 25.3 months compared to 16.0
months for letrozole alone[2]
-
Worldwide, an estimated 250,000
women will be diagnosed with advanced breast cancer each
year[3]
The digital
press release with multimedia content can be accessed
here:
Basel, June 23, 2017
- Novartis today announced the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) has adopted a positive opinion recommending approval
of Kisqali® (ribociclib)
in combination with an aromatase inhibitor for treatment of
postmenopausal women with hormone receptor positive, human
epidermal growth factor receptor-2 negative (HR+/HER2-) locally
advanced or metastatic breast cancer as initial endocrine-based
therapy. The CHMP recommendation of combining Kisqali with any
aromatase inhibitor means that, if approved, oncologists could
prescribe Kisqali with letrozole, anastrozole or exemestane, giving
them the discretion to select the therapy they believe is most
appropriate for each individual patient.
"This positive CHMP opinion brings us one step
closer to improving the lives of women diagnosed with advanced or
metastatic breast cancer throughout Europe," said Bruno Strigini,
CEO, Novartis Oncology. "There is currently no cure for advanced
breast cancer, and approximately 30 percent of those affected by
early-stage breast cancer will go on to develop advanced disease.
We look forward to working with European health authorities to make
Kisqali available to those who may benefit from it as quickly as
possible."
The positive CHMP opinion is based on superior
efficacy and demonstrated safety of Kisqali plus letrozole versus
letrozole alone in the pivotal Phase III MONALEESA-2 trial. The
trial, which globally enrolled 668 postmenopausal women with
HR+/HER2- advanced or metastatic breast cancer who received no
prior systemic therapy for their advanced breast cancer, showed
that Kisqali plus the aromatase inhibitor letrozole reduced the
risk of progression or death by 44% over letrozole alone at interim
analysis[1]. Most adverse events in the MONALEESA-2 trial were mild
to moderate in severity, identified early through routine
monitoring, and generally managed through dose interruption and/or
reduction[1].
A subsequent, pre-planned analysis of overall
survival with an additional 11 months of follow-up demonstrated a
median PFS of 25.3 months for Kisqali plus letrozole and 16.0
months for letrozole alone (HR=0.568 (95% CI: 0.457-0.704;
p<0.0001))[2]. More than half of women with measurable disease
taking Kisqali plus letrozole saw their tumor size shrink by at
least 30% (overall response rate (ORR) in patients with measurable
disease = 55% vs 39%, p=0.00025)[2],[4]. Follow-up to measure
overall survival is ongoing as data remain immature[4].
The European Commission will review the CHMP
recommendation and usually delivers its final decision within two
months. The decision will be applicable to all 28 European Union
member states plus Iceland, Norway and Liechtenstein. Additional
regulatory filings are underway with other health authorities
worldwide.
In March 2017, Kisqali was approved by the US Food
and Drug Administration (FDA) in combination with an aromatase
inhibitor as initial endocrine-based therapy for treatment of
postmenopausal women with HR+/HER2- advanced or metastatic breast
cancer. Kisqali can be taken with or without food as a once-daily
oral dose of 600 mg (three 200 mg film-coated tablets) for three
weeks, followed by one week off treatment. Kisqali is taken in
combination with four weeks of any aromatase inhibitor.
Globally, an estimated 250,000 women will be
diagnosed with advanced breast cancer each year[3]. Up to one-third
of patients with early-stage breast cancer will subsequently
develop metastatic disease, for which there is currently no
cure[5],[6].
About Kisqali®
(ribociclib)
Kisqali (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, can enable
cancer cells to grow and divide too quickly. Targeting CDK4/6 with
enhanced precision may play a role in ensuring that cancer cells do
not continue to replicate uncontrollably.
Kisqali was developed by the Novartis Institutes
for BioMedical Research (NIBR) under a research collaboration with
Astex Pharmaceuticals. In the European Union, Kisqali is an
investigational agent and has not been approved.
About the Kisqali Clinical Trial
Program
Novartis is continuing to assess Kisqali through the robust
MONALEESA clinical trial program, which includes two additional
Phase III trials, MONALEESA-3 and MONALEESA-7 that are evaluating
Kisqali in combination with multiple endocrine therapy partners
across a broad range of patients, including premenopausal women.
MONALEESA-3 is evaluating Kisqali in combination with fulvestrant
compared to fulvestrant alone in postmenopausal women with
HR+/HER2- advanced breast cancer who have received no or a maximum
of one prior endocrine therapy. MONALEESA-7 is investigating
Kisqali in combination with endocrine therapy and goserelin
compared to endocrine therapy and goserelin alone in premenopausal
women with HR+/HER2- advanced breast cancer who have not previously
received endocrine therapy. These trials are fully enrolled.
Novartis is initiating two multi-center,
randomized, double-blind Phase III clinical trials, EarLEE-1 and
EarLEE-2, to evaluate the safety and efficacy of Kisqali with
endocrine therapy as adjuvant therapy in pre- and postmenopausal
women who have not previously received treatment with CDK4/6 or
aromatase inhibitors. EarLEE-1 will assess Kisqali with adjuvant
endocrine therapy compared to adjuvant endocrine therapy alone in
women with HR+/HER2- high-risk early breast cancer. EarLEE-2 will
investigate Kisqali with adjuvant endocrine therapy compared to
adjuvant endocrine therapy alone in women with HR+/HER2-
intermediate-risk early breast cancer.
The CompLEEment study is evaluating the safety and
efficacy of Kisqali plus letrozole in men and pre- or
postmenopausal women with HR+/HER2- advanced breast cancer with no
prior hormonal therapy for advanced disease. The open-label,
multicenter, Phase IIIb CompLEEment-1 trial is currently enrolling
participants.
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. 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.
Kisqali®
(ribociclib) Important
Safety Information FROM THE US PRESCRIBING
INFORMATION
KISQALI® (ribociclib)
is a prescription medicine used in combination with an aromatase
inhibitor as the first hormonal-based therapy to treat women who
have gone through menopause with hormone receptor (HR)-positive,
human epidermal growth factor receptor 2 (HER2)-negative advanced
or metastatic breast cancer. It is not known if KISQALI is safe and
effective in children. KISQALI can cause a heart problem known as
QT prolongation. This condition can cause an abnormal heartbeat and
may lead to death. Patients should tell their health care provider
right away if they have a change in their heartbeat (a fast or
irregular heartbeat), or if they feel dizzy or faint. KISQALI can
cause serious liver problems. Patients should tell their health
care provider right away if they get any of the following signs and
symptoms of liver problems: yellowing of the skin or the whites of
the eyes (jaundice), dark or brown (tea-colored) urine, feeling
very tired, loss of appetite, pain on the upper right side of the
stomach area (abdomen), and bleeding or bruising more easily than
normal. Low white blood cell counts are very common when taking
KISQALI and may result in infections that may be severe. Patients
should tell their health care provider right away if they have
signs and symptoms of low white blood cell counts or infections
such as fever and chills. Before taking KISQALI, patients should
tell their health care provider if they are pregnant, or plan to
become pregnant as KISQALI can harm an unborn baby. Females who are
able to become pregnant and who take KISQALI should use effective
birth control during treatment and for at least 3 weeks after the
last dose of KISQALI. Do not breastfeed during treatment with
KISQALI and for at least 3 weeks after the last dose of KISQALI.
Patients should tell their health care provider about all of the
medicines they take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements since they may interact
with KISQALI. Patients should avoid pomegranate or pomegranate
juice, and grapefruit or grapefruit juice while taking KISQALI. The
most common side effects (incidence >=20%) of KISQALI when used
with letrozole include white blood cell count decreases, nausea,
tiredness, diarrhea, hair thinning or hair loss, vomiting,
constipation, headache, and back pain. The most common grade
3/4 side effects in the KISQALI + letrozole arm (incidence
>2%) were low neutrophils, low leukocytes, abnormal liver
function tests, low lymphocytes, and vomiting. Abnormalities were
observed in hematology and clinical chemistry laboratory tests.
Please see full Prescribing Information for
KISQALI, available at www.kisqali.com.
Disclaimer
The foregoing release contains forward-looking statements that can
be identified by words such as "positive CHMP opinion," "will,"
"positive opinion," "recommending," "CHMP recommendation," "could,"
"one step closer," "look forward," "ongoing," "within two months,"
"may," "investigational," "continuing to assess," "evaluating,"
"investigating," "pipelines," "in development," or similar terms,
or by express or implied discussions regarding potential new
indications or labeling for Kisqali or any of the other products in
the Novartis breast cancer pipeline, regarding potential marketing
approvals for Kisqali or any of the other products in the Novartis
breast cancer pipeline, or regarding potential future revenues from
Kisqali and the 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 Kisqali or any of the
other products in the Novartis breast cancer pipeline will be
submitted or approved for any additional indications or labeling in
any market, or at any particular time. Neither can there be any
guarantee that Kisqali will be submitted or approved for sale in
any market, or at any particular time. Nor can there be any
guarantee that any of the other products in the Novartis breast
cancer pipeline will be submitted or approved for sale in any
market, or at any particular time. Neither can there be any
guarantee that Kisqali or any of the other products in the Novartis
breast cancer pipeline will be commercially successful in the
future. In particular, management's expectations regarding Kisqali
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 clinical trial results and
additional analysis of existing clinical data; 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
healthcare cost containment, including ongoing pricing and
reimbursement pressures; 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, cost-saving generic and
biosimilar pharmaceuticals and eye care. Novartis has leading
positions globally in each of these areas. In 2016, the Group
achieved net sales of USD 48.5 billion, while R&D throughout
the Group amounted to approximately USD 9.0 billion. Novartis Group
companies employ approximately 118,000 full-time-equivalent
associates. Novartis products are sold in approximately 155
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. Ribociclib as a
first-line therapy for HR-positive, advanced breast cancer.
New England Journal of Medicine.
2016.
[2] Hortobagyi G, Stemmer S, Burris H, et al. Updated results from
MONALEESA-2, a phase III trial of first-line ribociclib plus
letrozole in hormone receptor-positive HER2-negative advanced
breast cancer. Presented at the 53rd Annual
Meeting of the American Society of Clinical Oncology (ASCO), June
4, 2017, Chicago, Illinois (abstract #1038).
[3] Buckley N, Isherwood A. Breast Cancer. Decision Resources.
March 2011:1-301.4
[4] Novartis Data on File
[5] O'Shaughnessy J. Extending survival with chemotherapy in
metastatic breast cancer. The Oncologist. 2005;10(Suppl
3):20-29.
[6] Baselga, J. Everolimus in Postmenopausal
Hormone-Receptor-Positive Advanced Breast Cancer. New England
Journal of Medicine. February 9, 2012.
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