01.05.2018 22:26:49
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Press Release: Kymriah(R) (tisagenlecleucel), -2-
for global clinical trials.
Novartis Leadership in Immuno-Oncology
Novartis is at the forefront of investigational immunocellular therapy
as the first pharmaceutical company to initiate global CAR-T trials, and
has significantly invested in CAR-T research and worked with pioneers in
the field. Kymriah, the first approved CAR-T cell therapy, is the
cornerstone of this strategy. Active research programs are underway
targeting other hematologic malignancies and solid tumors, and include
efforts focused on next generation CAR-Ts that involve simplified
manufacturing schemes and gene edited cells.
Kymriah(R) (tisagenlecleucel) US Important Safety information
Kymriah may cause side effects that are severe or life-threatening, such
as Cytokine Release Syndrome (CRS) or Neurological Toxicities. Patients
with CRS may experience symptoms including difficulty breathing, fever
(100.4degF/38degC or higher), chills/shaking chills, severe nausea,
vomiting and diarrhea, severe muscle or joint pain, very low blood
pressure, or dizziness/lightheadedness. Patients may be admitted to the
hospital for CRS and treated with other medications.
Patients with neurological toxicities may experience symptoms such as
altered or decreased consciousness, headaches, delirium, confusion,
agitation, anxiety, seizures, difficulty speaking and understanding, or
loss of balance. Patients should be advised to call their healthcare
provider or get emergency help right away if they experience any of
these signs and symptoms of CRS or neurological toxicities.
Because of the risk of CRS and neurological toxicities, Kymriah is only
available through a restricted program under a Risk Evaluation and
Mitigation Strategy (REMS) called Kymriah REMS.
Serious allergic reactions, including anaphylaxis, may occur after
Kymriah infusion.
Kymriah can increase the risk of life-threatening infections that may
lead to death. Patients should be advised to tell their healthcare
provider right away if they develop fever, chills, or any signs or
symptoms of an infection.
Patients may experience prolonged low blood cell counts (cytopenia),
where one or more types of blood cells (red blood cells, white blood
cells, or platelets) are decreased. The patient's healthcare provider
will do blood tests to check all of their blood cell counts after
treatment with Kymriah. Patients should be advised to tell their
healthcare provider right away if they get a fever, are feeling tired,
or have bruising or bleeding.
Patients may experience hypogammaglobulinemia, a condition in which the
level of immunoglobulins (antibodies) in the blood is low and the risk
of infection is increased. It is expected that patients may develop
hypogammaglobulinemia with Kymriah, and may need to receive
immunoglobulin replacement for an indefinite amount of time following
treatment with Kymriah. Patients should tell their healthcare provider
about their treatment with Kymriah before receiving a live virus
vaccine.
After treatment with Kymriah, patients will be monitored lifelong by
their healthcare provider, as they may develop secondary cancers or
recurrence of their cancer.
Patients should not drive, operate heavy machinery, or do other
dangerous activities for eight weeks after receiving Kymriah because the
treatment can cause temporary memory and coordination problems,
including sleepiness, confusion, weakness, dizziness, and seizures.
Some of the most common side effects of Kymriah are difficulty breathing,
fever (100.4degF/38degC or higher), chills/shaking chills, confusion,
severe nausea, vomiting and diarrhea, severe muscle or joint pain, very
low blood pressure, dizziness/lightheadedness, and headache. However,
these are not all of the possible side effects of Kymriah. Patients
should talk to their healthcare provider for medical advice about side
effects.
Prior to a female patient starting treatment with Kymriah, their
healthcare provider may do a pregnancy test. There is no information
available for Kymriah use in pregnant or breast-feeding women. Therefore,
Kymriah is not recommended for women who are pregnant or breast feeding.
Patients should talk to their healthcare provider about birth control
and pregnancy.
Patients should tell their healthcare provider about all the medicines
they take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements.
After receiving Kymriah, patients should be advised that some commercial
HIV tests may cause a false-positive test result. Patients should also
be advised not to donate blood, organs, or tissues and cells for
transplantation after receiving Kymriah.
Please see the full Prescribing Information for Kymriah, including Boxed
WARNING, and Medication Guide at www.Kymriah.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," "can," "will," "plan," "expect," "anticipate,"
"look forward," "believe," "committed," "investigational," "pipeline,"
"launch," or similar terms, or by express or implied discussions
regarding potential marketing approvals, new indications or labeling for
Kymriah or the other investigational products described in this press
release, regarding our ability to scale and sustain commercial
manufacturing for Kymriah or such other products, or regarding potential
future revenues from Kymriah and such other 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 Kymriah or the other
investigational 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. Neither can there be
any guarantee that Novartis will successfully scale and sustain
commercial manufacturing for Kymriah or the other products described in
this press release, or successfully sustain a network of treatment
centers to offer Kymriah. Nor can there be any guarantee that Novartis
will successfully establish and implement indication-based pricing for
Kymriah or the other investigational products described in this press
release, or that such indication-based pricing will achieve the intended
goals of such pricing. Neither can there be any guarantee that Kymriah
and such other products will be commercially successful in the future.
In particular, our expectations regarding Kymriah and such other
products could be affected by, among other things, our ability to
successfully scale and sustain commercial manufacturing and sustain a
network of treatment centers; our ability to successfully establish and
implement indication-based pricing; 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.
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 124,000
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] Kymriah (tisagenlecleucel) Prescribing information. East Hanover,
New Jersey, USA: Novartis Pharmaceuticals Corporation; April 2018.
[2] Vacirca JL et al., Ann Hematol. 2014;93(3):403-409.
[3] American Society of Clinical Oncology. Lymphoma - Non-Hodgkin:
Subtypes (Dec. 2016 revision).
http://www.cancer.net/cancer-types/lymphoma-non-hodgkin/subtypes.
Accessed April 2018.
[4] Raut, L., Chakrabarti, P. "Management of relapsed-refractory
diffuse large B cell lymphoma." South Asian J Can, 2014 Jan-Mar; 3(1):
66-7. Accessed April 2018.
[5] Crump M et al., "Outcomes in refractory diffuse large B-cell
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