-
Kisqali is now the only CDK4/6
inhibitor indicated in combination with an aromatase inhibitor as
first-line treatment for pre-, peri- or postmenopausal women with
HR+/HER2- advanced breast cancer in the US[1]
-
Kisqali is the only CDK4/6
inhibitor that is indicated with fulvestrant as both initial or
second-line treatment for postmenopausal women with HR+/HER2-
advanced breast cancer[1]
-
FDA approval is based on
MONALEESA-3 and MONALEESA-7 clinical trials, which demonstrated
robust efficacy of Kisqali combination therapy in multiple
treatment partners and settings[1]
-
First FDA approval using the
Real-Time Oncology Review and Assessment Aid pilot programs;
application approved in less than one month
Basel, July 18, 2018
- Novartis today announced a new approval for
Kisqali® (ribociclib)
from the US Food and Drug Administration (FDA) for women with
hormone-receptor positive, human epidermal growth factor receptor-2
negative (HR+/HER2-) advanced or metastatic breast cancer. Kisqali
is now the only CDK4/6 inhibitor indicated for use with an
aromatase inhibitor for the treatment of pre-, peri- or
postmenopausal women in the US, and also is indicated for use in
combination with fulvestrant as both first- or second-line therapy
in postmenopausal women[1]. FDA reviewed this supplemental New Drug
Application (sNDA) under its Real-Time Oncology Review and
Assessment Aid pilot programs and approved the application in less
than one month after submission.
"Compelling data for Kisqali have led to the
broadest first-line indications of any CDK4/6 inhibitor," said Liz
Barrett, CEO, Novartis Oncology. "With this new approval Kisqali
has the potential to help even more people in the US live a longer
life without progression of disease from this incurable form of
breast cancer."
This approval is based on the pivotal MONALEESA-7
and MONALEESA-3 Phase III clinical trials that demonstrated
prolonged progression-free survival (PFS) and improvements as early
as eight weeks for Kisqali-based regimens compared to endocrine
therapy alone[1]. In MONALEESA-7, Kisqali plus an aromatase
inhibitor and goserelin nearly doubled the median PFS compared to
an aromatase inhibitor and goserelin alone (27.5 months compared to
13.8 months; HR=0.569; 95% CI: 0.436-0.743) in pre- or
perimenopausal women[1]. In MONALEESA-3, Kisqali plus fulvestrant
demonstrated a median PFS of 20.5 months compared to 12.8 months
for fulvestrant alone (HR=0.593; 95% CI: 0.480-0.732) across the
overall population of first-line and second-line postmenopausal
women[1].
"These MONALEESA clinical trial program data add
to the body of evidence that CDK 4/6 inhibition, in the case of
these studies with ribociclib, gives women diagnosed with HR+/HER2-
advanced breast cancer an important first-line treatment option,"
said Dennis J. Slamon, MD, Director of Clinical/Translational
Research, University of California, Los Angeles Jonsson
Comprehensive Cancer Center. "Based on Phase III trial results that
consistently showed clinical benefit, physicians should be
encouraged to re-evaluate treatment for advanced breast cancer in
the first-line setting."
Approximately 155,000 people in the US are living
with metastatic breast cancer[2]. Up to one-third of patients with
early-stage breast cancer will subsequently develop advanced
disease, for which there is currently no cure[3]. Advanced breast
cancer in premenopausal women is a biologically distinct and more
aggressive disease, and it is the leading cause of cancer death in
women 20-59 years old[4],[5].
"Premenopausal women diagnosed with advanced
breast cancer often face unique social challenges and a poorer
prognosis. For the first time in nearly 20 years, we have results
from a dedicated clinical trial among these women," said Jennifer
Merschdorf, CEO, Young Survival Coalition. "With this approval,
some younger women now have a new therapy indicated specifically
for them that may help extend their lives without progression of
disease."
Novartis is committed to providing patients with
access to medicines, as well as resources and support to address a
range of needs. The Kisqali patient support program is available to
help guide eligible patients through the various aspects of getting
started on treatment, from providing educational information to
helping them understand their insurance coverage and identify
potential financial assistance options. For more information,
patients and healthcare professionals can call 1-800-282-7630.
Discussions with global health authorities
regarding the MONALEESA-3 and MONALEESA-7 data are ongoing.
About Kisqali Clinical Trial
Programs
With more than 2,000 patients enrolled in current trials, the
MONALEESA program is the largest industry sponsored Phase III
clinical program researching a CDK4/6 inhibitor in HR+/HER2-
advanced breast cancer:
-
MONALEESA-7 is the only Phase III global
registration trial investigating the efficacy and safety of a
CDK4/6 inhibitor, Kisqali, in combination with an aromatase
inhibitor plus goserelin versus an aromatase inhibitor plus
goserelin, in pre- or perimenopausal women with HR+/HER2- advanced
breast cancer who had not previously received endocrine therapy for
advanced disease. Results from the pre-specified NSAI-only subgroup
of 495 pre- or perimenopausal women with HR+/HER2- advanced breast
cancer who received no prior endocrine therapy for advanced disease
showed an estimated median progression-free survival (PFS, RECIST
1.1) of 27.5 months for patients on the Kisqali arm compared with
13.8 months for those on the placebo arm (HR 0.569; 95% CI: 0.436,
0.743). Kisqali is not indicated for concomitant use with
tamoxifen[6].
-
MONALEESA-3 is a Phase III global registration
trial 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. Nearly 70% of patients in MONALEESA-3
receiving Kisqali plus fulvestrant as initial therapy were
estimated to remain progression-free at the median follow-up of
16.5 months (median PFS not reached vs.18.3 months; HR=0.577; 95%
CI: 0.415-0.802)[1].
-
MONALEESA-2 is a Phase III global registration
trial evaluating Kisqali in combination with letrozole compared to
letrozole alone in postmenopausal women with HR+/HER2- advanced
breast cancer who received no prior therapy for advanced breast
cancer that led to the initial FDA approval. MONALEESA-2 is ongoing
to evaluate overall survival[1].
Across the pivotal trials (M2, M3, and M7), the
most common adverse reactions (incidence >=20%) were
neutropenia, nausea, infections, fatigue, diarrhea, leukopenia,
vomiting, alopecia, headache, constipation, rash and cough[1].
CompLEEment-1 is an open-label, multicenter, Phase
IIIb study evaluating the safety and efficacy of Kisqali plus
letrozole in pre- or postmenopausal women and men with HR+/HER2-
advanced breast cancer who have not received prior hormonal therapy
for advanced disease[6].
More information about these studies can be found
at www.ClinicalTrials.gov.
Novartis is continuing the development of Kisqali
in early breast cancer (EBC) through a collaboration with
Translational Research In Oncology (TRIO). The NATALEE study is a
Phase III clinical trial of Kisqali with endocrine therapy in the
adjuvant treatment of HR+/HER2- EBC[6].
About Kisqali® (ribociclib)
Kisqali 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[6].
Kisqali was initially approved by the US Food and
Drug Administration in March 2017 and by the European Commission in
August 2017, as initial endocrine-based therapy for postmenopausal
women with HR+/HER2- locally advanced or metastatic breast cancer
in combination with an aromatase inhibitor based on findings from
the pivotal MONALEESA-2 trial[6].
Kisqali is approved for use in more than 60
countries around the world, including the United States and
European Union member states. Kisqali is not currently approved for
use in combination with fulvestrant or in premenopausal women in
Europe. Kisqali was developed by the Novartis Institutes for
BioMedical Research (NIBR) under a research collaboration with
Astex Pharmaceuticals[6].
About Novartis in Advanced Breast
Cancer
For more than 30 years, Novartis has been tackling breast cancer
with superior science, great collaboration and a passion for
transforming patient care. With one of the most diverse breast
cancer pipelines and one of the largest numbers 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.
Important Safety
Information
KISQALI® (ribociclib)
is a prescription medicine used in combination with an aromatase
inhibitor as the first hormonal-based therapy to treat pre/peri-
and postmenopausal women and in combination with fulvestrant as the
first hormonal-based therapy or following disease progression on
hormonal therapy in postmenopausal women 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. KISQALI is not
indicated for concomitant use with tamoxifen due to an increased
risk of QT prolongation. 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 grapefruit or grapefruit juice while taking KISQALI. The most
common side effects (incidence >=20%) include white blood cell
count decreases, nausea, infections, tiredness, diarrhea, vomiting,
hair loss, headache, constipation, rash, and cough. The most common
Grade 3/4 side effects (incidence >5%) were low neutrophils, low
leukocytes, abnormal liver function tests, and low lymphocytes.
Abnormalities were observed in hematology and clinical chemistry
laboratory tests.
Please see full Prescribing Information for KISQALI, available
at www.kisqali.com.
Disclaimer
This press release contains forward-looking statements within the
meaning of the United States Private Securities Litigation Reform
Act of 1995. Forward-looking statements can generally be identified
by words such as "potential," "option," "should," "encouraged,"
"will," "may," "committed," "ongoing," "investigating,"
"evaluating," "continuing," "can," "may," "pipelines," or similar
terms, or by express or implied discussions
regarding potential marketing approvals, new indications or
labeling for Kisqali or the other investigational or approved
products described in this press release, or regarding potential
future revenues from such products. You should not place undue
reliance on these statements. Such forward-looking statements are
based on our current beliefs and expectations 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 the other investigational or approved products described in this
press release will be submitted or approved for sale or for any
additional indications or labeling in any market, or at any
particular time. Nor can there be any guarantee that Kisqali or the
other investigational or approved products described in this press
release will be commercially successful in the future. In
particular, our expectations regarding such products 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; global trends toward
health care cost containment, including government, payor and
general public pricing and reimbursement pressures; our ability to
obtain or maintain proprietary intellectual property protection;
the particular prescribing preferences of physicians and patients;
general political and economic conditions; safety, quality or
manufacturing issues; potential or actual data security and data
privacy breaches, or disruptions of our information technology
systems, 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.
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 2017, the Group
achieved net sales of USD 49.1 billion, while R&D throughout
the Group amounted to approximately USD 9.0 billion. Novartis Group
companies employ approximately 125,000 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] Kisqali
(ribociclib) Prescribing information. East Hanover, New Jersey,
USA: Novartis Pharmaceuticals Corporation; July 2018.
[2] Mariotto,
Angela B., et al. "Estimation of the Number of Women Living with
Metastatic Breast Cancer in the United States." Cancer Epidemiology
and Prevention Biomarkers 26.6 (2017): 809-815.
[3] Redig AJ, et
al. Breast cancer as a systemic disease: a view of metastasis. J
Intern Med. 2013; 274: 113-126.
[4] Benz CC. Impact
of aging on the biology of breast cancer. Crit Rev Oncol Hematol.
2008;66:65-74.
[5] World Health
Organization. Women's health fact sheet. September 2013. Available
at http://www.who.int/mediacentre/factsheets/fs334/en/. Accessed
July 2018.
[6] Novartis Data
on File.
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