Novartis drug combination Tafinlar® + Mekinist® receives EU approval for BRAF V600-positive advanced non-small cell lung cancer (NSCLC)
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Novartis International AG /
Novartis drug combination Tafinlar® + Mekinist® receives EU approval for BRAF
V600-positive advanced non-small cell lung cancer (NSCLC)
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The issuer is solely responsible for the content of this announcement.
* New indication of Tafinlar and Mekinist in advanced NSCLC provides only
therapy approved in the EU for BRAF V600-positive NSCLC
* Approval based on data showing more than 60% overall response rate in both
previously treated and untreated patients[1]
* Approximately 1-3% of patients with lung cancer are diagnosed annually with
BRAF V600-positive NSCLC worldwide
Basel, April 3, 2017 - Novartis today announced the European Commission has
approved Tafinlar(®) (dabrafenib) in combination with Mekinist(®) (trametinib)
for the treatment of patients with BRAF V600-positive advanced or metastatic
non-small cell lung cancer (NSCLC). The approval marks the first targeted
treatment approved for the patient population, who previously had few treatment
options, in all 28 member states of the European Union (EU), plus Iceland and
Norway. Every year, it is estimated, up to about 36,000 people, or about 1-3% of
patients with lung cancer, are diagnosed with BRAF V600-positive NSCLC
worldwide[2],[3].
"Today's approval represents an important milestone for the lung cancer
community, especially those patients living with the BRAF V600 mutation who
previously had few options," said Bruno Strigini, CEO, Novartis Oncology. "At
Novartis we are committed to bringing meaningful scientific advances that fill
critical unmet needs to patients."
Today's EU approval follows a positive opinion granted in February by the
Committee for Medicinal Products for Human Use (CHMP), which was based on safety
and efficacy of dabrafenib in combination with trametinib in a Phase II, three-
cohort, multicenter, non-randomised and open-label study in which patients with
stage IV BRAF V600E mutant NSCLC were enrolled (36 treatment-naïve [previously
untreated] and 57 previously treated with chemotherapy).
For the primary endpoint of investigator-assessed overall response rate (ORR),
36 treatment-naïve patients receiving 150 mg of Tafinlar twice daily and 2 mg of
Mekinist once daily demonstrated an ORR of 61.1% (95% confidence interval [CI]:
43.5%, 76.9%)[1]. In this population, 68% of patients had not progressed after
9 months[1]. The median duration of response (DoR) and progression free survival
(PFS) in the previously untreated population were not yet reached at the time of
approval[1]. In the previously treated population receiving the same dosage,
patients demonstrated an ORR of 66.7% (95% CI: 52.9%, 78.6%)[1]. The response
was durable with a median DoR reaching 9.8 months (95% CI: 6.9, 16.0)[1]. An
in-depth analysis of data from the treatment-naïve cohort will be presented at
an upcoming medical meeting.
The most common adverse events (incidence >20%) were pyrexia, nausea, vomiting,
peripheral edema, diarrhea, dry skin, decreased appetite, asthenia, chills,
cough, fatigue, rash, and dyspnoea[1].
The US Food and Drug Administration (FDA) granted Tafinlar + Mekinist
Breakthrough Therapy designation for advanced or metastatic BRAF V600E-positive
NSCLC patients in 2015 and Priority Review in November 2016. Combination use of
Tafinlar + Mekinist is also approved in the US, Europe, Australia, Canada, and
additional countries for patients with unresectable or metastatic melanoma whose
tumors tested positive for the BRAF V600 mutation.
Novartis Commitment to Lung Cancer
Worldwide, lung cancer causes more deaths than colon, breast, and prostate
cancer combined, and an estimated 1.8 million new cases of lung cancer are
diagnosed each year[2], [4]. Among patients with NSCLC, roughly 30% have an
actionable mutation that may be targeted with available therapies[5], [6], [7],
[8]. To determine that treatment, medical organizations recommend biomarker
testing for patients with lung cancer[9].
Novartis Oncology's research into targeted therapies has helped transform
treatment approaches for patients living with mutation-driven types of lung
cancer. Patients with mutation-driven NSCLC may be candidates for treatment with
targeted therapies[5].
Novartis continues its commitment to the global lung cancer community through
ongoing studies, as well as the exploration of investigational compounds that
target genetic biomarkers in NSCLC.
IMPORTANT SAFETY INFORMATION (ISI)
About Tafinlar + Mekinist Combination
Combination use of Tafinlar + Mekinist in patients with unresectable or
metastatic melanoma who have a BRAF V600 mutation is approved in the US, EU,
Australia, Canada, and additional countries. The combination of Tafinlar and
Mekinist is also approved for the treatment of advanced non-small cell lung
cancer with a BRAF V600 mutation in Europe.
Tafinlar and Mekinist target different kinases within the serine/threonine
kinase family - BRAF and MEK1/2, respectively - in the RAS/RAF/MEK/ERK pathway,
which is implicated in non-small cell lung cancer (NSCLC) and melanoma, among
other cancers. When Tafinlar is used with Mekinist, the combination has been
shown to slow tumor growth more than either drug alone. The combination of
Tafinlar + Mekinist is currently being investigated in an ongoing clinical trial
program across a range of tumor types conducted in study centers worldwide.
The safety and efficacy profile of the Tafinlar + Mekinist combination has not
yet been established outside of the approved indications.
Tafinlar and Mekinist are also indicated in more than 40 countries worldwide,
including the US and EU, as single agents to treat patients with unresectable or
metastatic melanoma with a BRAF V600 mutation.
Tafinlar + Mekinist Combination Important Safety Information
Tafinlar + Mekinist combination may cause serious side effects.
Tafinlar in combination with Mekinist should only be used to treat patients with
a change (mutation) in the BRAF gene; therefore, doctors should test their
patients before treatment, as patients without a BRAF mutation and with a RAS
mutation can be at risk of increased cell proliferation in the presence of a
BRAF inhibitor.
Doctors should also consider other treatment options for their patients if they
had been previously treated with a BRAF inhibitor as single agent, as the
limited data available have shown that the efficacy of Tafinlar + Mekinist is
lower in these patients.
When Tafinlar is used in combination with Mekinist, or when Tafinlar is
administered as monotherapy, it can cause new cancers (both skin cancer and non-
skin cancer). Patients should be advised to contact their doctor immediately for
any new lesions, changes to existing lesions on their skin, or signs and
symptoms of other malignancies.
Tafinlar in combination with Mekinist, or Mekinist alone, can cause severe
bleeding, and in some cases can lead to death. Patients should be advised to
call their healthcare provider and get medical help right away if they have
headaches, dizziness, or feel weak, cough up blood or blood clots, vomit blood
or their vomit looks like "coffee grounds," have red or black stools that look
like tar, or any unusual signs of bleeding.
Tafinlar in combination with Mekinist, or either drug alone, can cause severe
eye problems that can lead to blindness. Patients should be advised to call
their healthcare provider right away if they get these symptoms of eye problems:
blurred vision, loss of vision, or other vision changes, seeing color dots, halo
(seeing blurred outline around objects), eye pain, swelling, or redness.
Tafinlar in combination with Mekinist, or Tafinlar alone, can cause fever, which
may be serious. When taking Tafinlar in combination with Mekinist, fever may
happen more often or may be more severe. In some cases, chills or shaking
chills, too much fluid loss (dehydration), low blood pressure, dizziness, or
kidney problems may happen with the fever. Patients should be advised to call
their healthcare provider right away if they get a fever above 38.5(o)C
(101.3(o)F) while taking Tafinlar.
Tafinlar in combination with Mekinist, or Mekinist alone, can affect how well
the heart pumps blood. A patient's heart function should be checked before and
during treatment. Patients should be advised to call their healthcare provider
right away if they have any of the following signs and symptoms of a heart
problem: feeling like their heart is pounding or racing, shortness of breath,
swelling of their ankles and feet, or feeling lightheaded.
Tafinlar in combination with Mekinist, or Tafinlar alone, can cause abnormal
kidney function or inflammation of the kidney. Abnormal kidney function may
happen more often for patients with fever or too much fluid loss. Patients
should be advised to call their healthcare provider right away if they have a
fever above 38.5(o)C (101.3(o)F), decreased urine, fatigue, loss of appetite, or
discomfort in lower abdomen or back. Tafinlar has not been studied in patients
with renal insufficiency (defined as creatinine > 1.5 x ULN), therefore caution
should be used in this setting.
Tafinlar in combination with Mekinist, or Mekinist alone, can cause abnormal
liver function. A patient may feel tired, lose appetite, yellow skin, dark urine
colour, or discomfort in abdomen. The liver function abnormality needs to be
assessed by laboratory test of the blood. Patients should consult their
healthcare provider if they have such experience. Administration of Tafinlar or
Mekinist should be done with caution in patients with moderate to severe hepatic
impairment.
Elevations in blood pressure have been reported in association with Mekinist in
combination with Tafinlar, or with Mekinist alone, in patients with or without
pre-existing hypertension. Patients should be advised to monitor blood pressure
during treatment with Mekinist and control potential hypertension by standard
therapy, as appropriate.
Tafinlar in combination with Mekinist, or Mekinist alone, can cause inflammation
of the lung tissue. Patients should notify their doctor if they experience any
new or worsening symptoms of lung or breathing problems, including shortness of
breath or cough.
Rash is a common side effect of Tafinlar in combination with Mekinist, or with
Mekinist alone. Tafinlar in combination with Mekinist, or Mekinist alone, can
also cause other skin reactions, which can be severe, and may need to be treated
in a hospital. Patients should be advised to call their healthcare provider if
they get any of the following symptoms: skin rash that bothers them or does not
go away, acne, redness, swelling, peeling, or tenderness of hands or feet, skin
redness.
Tafinlar in combination with Mekinist, or Mekinist alone, can cause muscle
breakdown, a condition called Rhabdomyolysis. Patients experiencing muscle pain,
tenderness, weakness, or a swelling of their muscles should contact their
healthcare provide immediately.
Tafinlar in combination with Mekinist, or Tafinlar alone, can uncommonly cause
an inflammation of the pancreas (pancreatitis). Patients should be promptly
investigated if they experience unexplained abdominal pain and closely monitored
if they re-start Tafinlar after a prior episode of pancreatitis.
Tafinlar in combination with Mekinist, or Mekinist alone, can cause blood clots
in the arms or legs, which can travel to the lungs and can lead to death.
Patients should be advised to get medical help right away if they have the
following symptoms: chest pain, sudden shortness of breath or trouble breathing,
pain in their legs with or without swelling, swelling in their arms or legs, or
a cool or pale arm or leg.
Mekinist in combination with Tafinlar, or Mekinist alone, may increase the risk
of developing holes in the stomach or intestine (gastrointestinal perforation).
Treatment with Mekinist alone or in combination with Tafinlar should be used
with caution in patients with risk factors for gastrointestinal perforation,
including concomitant use of medications with a recognized risk of
gastrointestinal perforation.
Tafinlar and Mekinist both can cause harm to an unborn baby when taken by a
pregnant woman. Tafinlar can also render hormonal contraceptives ineffective.
The most common side effects of Tafinlar + Mekinist combination include fever,
nausea, diarrhea, fatigue, chills, headache, vomiting, joint pain, high blood
pressure, rash, and cough. The incidence and severity of fever is increased when
Mekinist is used in combination with Tafinlar.
Patients should tell their doctor of any side effect that bothers them or does
not go away. These are not all of the possible side effects of Tafinlar +
Mekinist combination. For more information, patients should ask their doctor or
pharmacist.
Patients should take Tafinlar + Mekinist combination exactly as their health
care provider tells them. Patients should not change their dose or stop taking
Tafinlar + Mekinist combination unless their health care provider advises them
to. Mekinist should be taken only once daily (either in the morning or evening,
at the same time as Tafinlar). The first and second doses of Tafinlar should be
taken approximately 12 hours apart. Patients should take Tafinlar + Mekinist at
least 1 hour before or 2 hours after a meal. Do not take a missed dose of
Tafinlar within 6 hours of the next dose of Tafinlar. Do not open, crush, or
break Tafinlar capsules. Do not take a missed dose of Mekinist within 12 hours
of the next dose of Mekinist.
Please see full Prescribing Information for Tafinlar and Mekinist.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "estimated," "milestone," "committed," "will," "Breakthrough
Therapy designation," "Priority Review," "commitment," "may," "recommend,"
"continues," "ongoing," "exploration," "investigational," or similar terms, or
by express or implied discussions regarding potential new indications or
labeling for Tafinlar + Mekinist or any of the other products in the Novartis
lung cancer pipeline, regarding potential marketing approvals for Tafinlar +
Mekinist or any of the other products in the Novartis lung cancer pipeline, or
regarding potential future revenues from Tafinlar + Mekinist and the other
products in the Novartis lung 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 Tafinlar
+ Mekinist or any of the other products in the Novartis lung 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
Tafinlar + Mekinist will be submitted or approved for sale in any additional
markets, or at any particular time. Nor can there be any guarantee that any of
the other products in the Novartis lung cancer pipeline will be submitted or
approved for sale in any market, or at any particular time. Neither can there be
any guarantee that Tafinlar + Mekinist or any of the other products in the
Novartis lung cancer pipeline will be commercially successful in the future. In
particular, management's expectations regarding Tafinlar + Mekinist and the
other products in the Novartis lung 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 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] Tafinlar® (dabrafenib) + Mekinist® (trametinib) Summary of Product
Characteristics.
[2] World Health Organization. International Agency for Research on Cancer.
GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in
2012. Lung Cancer. Available at
http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx?cancer=lung. Accessed
February 2, 2017.
[3] Pao W, Girard N. New driver mutations in non-small-cell lung cancer. 2011.
Lancet Oncol. 12: 175-180.
[4] World Health Organization. Estimated number of deaths, both sexes, worldwide
in 2012. World Health Organization. http://gco.iarc.fr/today/online-analysis-
pie?mode=cancer&mode_population=
continents&population=900&sex=0&cancer=11&type=1&statistic=0&prevalence=0&color
_palette=default. Accessed on January 19, 2017.
[5] Riess JW, Wakelee, HA. Metastatic Non-Small Cell Lung Cancer Management:
Novel Targets and Recent Clinical Advances. Clinical Advances in Hematology &
Oncology. 2012; 10: 226-224.
[6] Pao W, Girard N. New driver mutations in non-small-cell lung cancer. Lancet
Oncol. 2011;12:175-180.
[7] Paik PK, Arcila ME, Fara M, et al. Clinical Characteristics of Patients With
Lung Adenocarcinomas Harboring BRAF Mutations. J Clin Oncol. 2011;29:2046-2051.
[8] Takeuchi, K, Soda M, Togashi Y, et al. RET, ROS1 and ALK fusions in lung
cancer. Nature. 2012;378-381.
[9] Lindeman, N.I., et al. Molecular Testing Guideline for Selection of Lung
Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors. Arch Pathol Lab
Med. 2013; 137: 828-1174.
# # #
Novartis Media Relations
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Source: Novartis International AG via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 03.04.2017 - 07:15 Uhr
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News-ID 533922
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