22.08.2020 07:14:40
|
Press Release: Novartis provides update on Phase -2-
arthralgia, peripheral edema, and cough. The most common side effects
for patients with stage III melanoma receiving the combination as
adjuvant therapy are: pyrexia, fatigue, nausea, headache, rash, chills,
diarrhea, vomiting, arthralgia, and myalgia. The most common side
effects for patients with NSCLC: pyrexia, fatigue, nausea, vomiting,
diarrhea, dry skin, decreased appetite, edema, rash, chills, hemorrhage,
cough, and dyspnea.
Please see full Prescribing Information for Tafinlar at
https://www.novartis.us/sites/www.novartis.us/files/tafinlar.pdf
and Mekinist at :
https://www.novartis.us/sites/www.novartis.us/files/mekinist.pdf
https://www.novartis.us/sites/www.novartis.us/files/mekinist.pdf.
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," "potentially," "will," "may," "could," "should,"
"believe," "committed," "investigational," "continues," "to support,"
"approximately," or similar terms, or by express or implied discussions
regarding potential marketing approvals, new indications or labeling for
spartalizumab and Tafinlar + Mekinist, separately or in combination, or
regarding potential future revenues from spartalizumab and Tafinlar +
Mekinist, separately or in combination. 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 spartalizumab and Tafinlar + Mekinist,
separately or in combination, 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 spartalizumab and
Tafinlar + Mekinist, separately or in combination, will be commercially
successful in the future. In particular, our expectations regarding
spartalizumab and Tafinlar + Mekinist, separately or in combination,
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 and requirements for increased
pricing transparency; our ability to obtain or maintain proprietary
intellectual property protection; the particular prescribing preferences
of physicians and patients; general political, economic and business
conditions, including the effects of and efforts to mitigate pandemic
diseases such as COVID-19; safety, quality, data integrity 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 is reimagining medicine to improve and extend people's lives.
As a leading global medicines company, we use innovative science and
digital technologies to create transformative treatments in areas of
great medical need. In our quest to find new medicines, we consistently
rank among the world's top companies investing in research and
development. Novartis products reach nearly 800 million people globally
and we are finding innovative ways to expand access to our latest
treatments. About 109,000 people of more than 140 nationalities work at
Novartis around the world. Find out more at https://www.novartis.com.
Novartis is on Twitter. Sign up to follow @Novartis at
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https://www.novartis.com/news/media-library
https://www.novartis.com/news/media-library
For questions about the site or required registration, please contact
media.relations@novartis.com
Novartis Media Relations
E-mail: media.relations@novartis.com
Anja von Treskow Mary Curtin Creaser
Novartis External Communications Novartis Oncology Communications
+41 79 392 8697 +1 862 345 4102
anja.von_treskow@novartis.com mary.curtin_creaser@novartis.com
Eric Althoff
Novartis US External Communications
+1 646 438 4335
eric.althoff@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 Sloan Simpson +1 862 778 5052
Thomas Hungerbuehler +41 61 324 8425
Isabella Zinck +41 61 324 7188
References
1. Hauschild A, et al. Long-term benefit of adjuvant dabrafenib + trametinib
(D+T) in patients (pts) with resected stage III BRAF V600--mutant
melanoma: 5-year analysis of COMBI-AD. Abstract #10001. 2020 American
Society of Clinical Oncology Annual Meeting, May 29-June 2, Chicago, IL.
2. Robert C, et al. Five-Year Outcomes with First-Line Dabrafenib plus
Trametinib in Metastatic Melanoma. The New England Journal of Medicine.
2019.
3. ClinicalTrials.gov. A Study of the Anti-PD1 Antibody PDR001, in
Combination With Dabrafenib and Trametinib in Advanced Melanoma
(COMBI-i). https://clinicaltrials.gov/ct2/show/NCT02967692.
(END) Dow Jones Newswires
August 22, 2020 01:15 ET (05:15 GMT)
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