Press Release: Novartis receives FDA approval of -2-

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

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

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; 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] Long GV, Hauschild A, Santinami M, et al. Adjuvant Dabrafenib

Plus Trametinib for Stage III BRAF V600E/K-Mutant Melanoma. New England

Journal of Medicine. 2017.

[2] Melanoma Skin Cancer. American Cancer Society. Available at:

http://www.cancer.org/acs/groups/cid/documents/webcontent/003120-pdf.pdf.

Accessed December 19, 2017.

[3] Heinzerling L, Kuhnapfel S, Meckbach D. Rare BRAF mutations in

melanoma patients: implications for molecular testing in clinical

practice. British Journal of Cancer. 2013.

[4] Melanoma Research Alliance. Adjuvant Therapy. Available at

http://www.curemelanoma.org/about-melanoma/melanoma-treatment/adjuvant-therapy/.

Accessed December 19, 2017.

# # #

Novartis Media Relations

Central media line: +41 61 324 2200

E-mail: media.relations@novartis.com

Eric Althoff Kristen Klasey

Novartis Global Media Relations Novartis Oncology Communications

+41 61 324 7999 (direct) +1 862 7784763 (direct)

+41 79 593 4202 (mobile) +1 862 7541732 (mobile)

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