16.06.2018 11:30:00
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Press Release: Novartis JULIET trial of Kymriah -2-
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, regarding our ability to scale and sustain commercial
manufacturing for Kymriah, or regarding potential future revenues from
Kymriah. 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 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 successfully
sustain a network of treatment centers to offer Kymriah. Nor can there
be any guarantee that Kymriah will be commercially successful in the
future. In particular, our expectations regarding Kymriah could be
affected by, among other things, our ability to successfully scale and
sustain commercial manufacturing and sustain a network of treatment
centers; 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.
Novartis is on Twitter. Sign up to follow @Novartis at
http://twitter.com/novartis
For Novartis multimedia content, please visit
www.novartis.com/news/media-library
For questions about the site or required registration, please contact
media.relations@novartis.com
References
[1] Borchmann P., Tam CS., Jager U., et al. An updated analysis of
JULIET, a global pivotal Phase 2 trial of tisagenlecleucel in adult
patients with relapsed or refractory (r/r) diffuse large b-cell lymphoma
(DLBCL) [abstract]. In: The 23rd Congress of EHA.; June 14-17; Stockholm,
Sweden.
[2] World Health Organization. Diffuse large B-cell lymphoma. Review
of cancer medicines on the WHO list of essential medicines. Available at
http://www.who.int/selection_medicines/committees/expert/20/applications/
DiffuseLargeBCellLymphoma.pdf. Accessed June 2018.
[3] Teras, L., et al. 2016 US lymphoid malignancy statistics by World
Health Organization subtypes. CA Cancer J Clin 2016;66:443-459.
https://doi.org/10.3322/caac.21357. Accessed June 2018.
[4] Tilly, H., et al. Diffuse large B-cell lymphoma (DLBCL): ESMO
Clinical Practice Guidelines for diagnosis, treatment and follow-up.
Annals of Oncology, Volume 26, Issue suppl_5, 1 September 2015, Pages
v116-v125, https://doi.org/10.1093/annonc/mdv304. Accessed June 2018.
[5] Raut, L., Chakrabarti, P. "Management of relapsed-refractory
diffuse large B cell lymphoma." South Asian J Can, 2014 Jan-Mar; 3(1):
66-70. Accessed June 2018.
[6] Crump M, et al. "Outcomes in refractory diffuse large B-cell
lymphoma: results from the international SCHOLAR-1 study", Blood. 2017
Oct 19;130(16):1800-1808. Available on
https://www.ncbi.nlm.nih.gov/pubmed/28774879. Accessed June 2018.
# # #
Novartis Media Relations
Central media line: +41 61 324 2200
E-mail: media.relations@novartis.com
Eric Althoff Fiona Phillips
Novartis Global Media Relations Novartis Oncology Communications
+41 61 324 7999 (direct) +1 862-778-7705 (direct)
+41 79 593 4202 (mobile) +1 862-217-9396 (mobile)
eric.althoff@novartis.com fiona.phillips@novartis.com
Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations@novartis.com
Central North America
Samir Shah +41 61 324 7944 Richard Pulik +1 212 830 2448
Pierre-Michel Bringer +41 61 324 1065 Cory Twining +1 212 830 2417
Thomas Hungerbuehler +41 61 324 8425
Isabella Zinck +41 61 324 7188
Media release (PDF): http://hugin.info/134323/R/2199656/852964.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the information
contained therein.
Source: Novartis International AG via Globenewswire
--- End of Message ---
Novartis International AG
P.O. Box Basel Switzerland
WKN: 904278;ISIN: CH0012005267;
http://www.novartis.com
(END) Dow Jones Newswires
June 16, 2018 05:30 ET (09:30 GMT)
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