Press Release: Novartis announces FDA approval of -2-

baby. They should use an effective method of birth control during

treatment with TABRECTA and for 1 week after the last dose. Men who have

partners who can become pregnant should use effective birth control

during treatment with TABRECTA and for 1 week after the last dose.

Before taking TABRECTA, patients should tell their health care provider

about all their medical conditions, including if they have or have had

lung or breathing problems other than lung cancer, have or have had

liver problems, or if they are pregnant or plan to become pregnant, as

TABRECTA can harm their unborn babies. Females who are able to become

pregnant should have a pregnancy test before they start treatment with

TABRECTA and should use effective birth control during treatment and for

1 week after the last dose of TABRECTA. Patients should be advised to

talk to their health care provider about birth control choices that

might be right for them during this time and to tell their health care

provider right away if they become pregnant or think they may be

pregnant during treatment with TABRECTA. Males who have female partners

who can become pregnant should use effective birth control during

treatment and for 1 week after their last dose of TABRECTA.

Patients should tell their health care provider about all the medicines

they take or start taking, including prescription and over-the-counter

medicines, vitamins, and herbal supplements.

The most common side effects of TABRECTA include swollen hands, ankles,

or feet (peripheral edema); nausea and/or vomiting; tiredness and/or

weakness (fatigue, asthenia); shortness of breath (dyspnea); loss of

appetite; changes in bowel movements (diarrhea or constipation); cough;

pain in the chest; fever (pyrexia); back pain; and decreased weight.

Please see full Prescribing Information for Tabrecta available at

https://www.novartis.us/sites/www.novartis.us/files/tabrecta.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," "can," "will," "plan," "may," "could," "would,"

"expect," "anticipate," "seek," "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 the 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 the 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 such products 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 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 145 nationalities work at

Novartis around the world. Find out more at https://www.novartis.com.

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References

1. Tabrecta(TM) (capmatinib) Prescribing Information. East Hanover, New

Jersey, USA: Novartis Pharmaceuticals Corporation; May 2020.

2. Data on file. Novartis Calculation. Kantar Health. CancerMPact: lung

(non-small cell) stage IV incidence and newly recurrent. Updated December

15, 2018. my.khapps.com.

3. Cappuzzo F, et al. Increased MET gene copy number negatively affects

survival of surgically resected non-small-cell lung cancer patients.

Journal of Clinical Oncology. 2009;27:1667-1674.

4. World Health Organization. Cancer Fact Sheet, 2018. Available at:

https://www.who.int/news-room/fact-sheets/detail/cancer. Accessed

December 13, 2019.

5. American Cancer Society. Key Statistics for Lung Cancer. Available at

https://www.cancer.org/cancer/lung-cancer/about/key-statistics.html.

Accessed March 10, 2020.

6. Hirsch FR, Suda K, Wiens J, et al. New and emerging targeted treatments

in advanced non-small-cell lung cancer. Lancet. 2016;388:1012-1024.

7. Sadiq AA, Salgia R. MET as a possible target for non-small-cell lung

cancer. Journal of Clinical Oncology. 2013;31:1089-1096.

8. Smyth EC, et al. Emerging molecular targets in oncology: clinical

potential of MET/hepatocyte growth-factor inhibitors. Onco Targets and

Therapy. 2014;7:1001-1014.

9. Salgia R. MET in Lung Cancer: Biomarker Selection Based on Scientific

Rationale. Molecular Cancer Therapeutics. 2017;16(4):555-565.

*FoundationOne(R) CDx is a registered trademark of Foundation Medicine,

Inc.

# # #

Novartis Media Relations

E-mail: media.relations@novartis.com

Anja von Treskow Rosemarie Yancosek

Novartis External Communications Novartis Oncology Communications

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anja.von_treskow@novartis.com +1 862 505 9021 (mobile)

Eric Althoff rosemarie.yancosek@novartis.com

Novartis US External Communications

+1 646 438 4335

eric.althoff@novartis.com

Novartis Investor Relations

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(END) Dow Jones Newswires

May 06, 2020 14:29 ET (18:29 GMT)