Novartis ribociclib (Kisqali®) only Category 1 preferred first-line treatment option for HR+/HER2- mBC in combination with an AI in updated NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)

Mar 28, 2023

East Hanover, March 28, 2023 — Updates to the NCCN Guidelines^® for breast cancer, released in January 2023, recommend ribociclib (Kisqali^®) as the only Category 1 preferred CDK4/6 inhibitor (CDK4/6i) for first-line treatment of patients with hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) metastatic breast cancer (mBC) when combined with an aromatase inhibitor (AI). This recommendation indicates high levels of clinical evidence and uniform consensus among NCCN on ribociclib (Kisqali) as an appropriate treatment.

NCCN Guidelines also continue to recommend ribociclib (Kisqali) plus fulvestrant as a Category 1 preferred regimen for first- and subsequent-line therapies* in HR+/HER2- mBC.

The latest NCCN Guidelines recommend ribociclib (Kisqali) for demonstrating significant overall survival (OS) benefit in combination with various endocrine therapies across three Phase III MONALEESA trials in HR+/HER2- mBC and uniquely in combination with an AI in the first-line setting in MONALEESA-2. These recent updates to the guidelines reinforce key distinctions among the CDK4/6i in mBC, driving the potential to enhance patient access to the latest evidence-based care and to improve outcomes.

In addition to consistently demonstrating statistically significant OS benefit, Kisqali preserved or improved patients’ quality of life in all three Phase III MONALEESA trials.

To access NCCN Guidelines, visit www.nccn.org.

* If CDK4/6 inhibitor was not previously used.

Indications

KISQALI^® (ribociclib) is a prescription medicine used to treat adults with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2−) breast cancer that has gotten worse or has spread to other parts of the body (metastatic), in combination with:

an aromatase inhibitor as the first endocrine-based therapy; or
fulvestrant as the first endocrine-based therapy or following disease progression on endocrine therapy in postmenopausal women or in men.

It is not known if KISQALI is safe and effective in children.

Important Safety Information

What is the most important information I should know about KISQALI?

KISQALI may cause serious side effects, including:
Lung problems. KISQALI may cause severe or life-threatening inflammation of the lungs during treatment that may lead to death. Tell your health care provider right away if you have any new or worsening symptoms, including:

trouble breathing or shortness of breath
cough with or without mucus
chest pain

Severe skin reactions. Tell your health care provider or get medical help right away if you get severe rash or rash that keeps getting worse; reddened skin; flu-like symptoms; skin pain/burning; blistering of the lips, eyes, or mouth; or blisters on the skin or skin peeling, with or without fever.
Heart rhythm problems (QT prolongation). KISQALI can cause a heart problem known as QT prolongation. This condition can cause an abnormal heartbeat and may lead to death. Your health care provider should check your heart and do blood tests before and during treatment with KISQALI. Tell your health care provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you feel dizzy or faint.
Liver problems (hepatobiliary toxicity). KISQALI can cause serious liver problems. Your health care provider should do blood tests to check your liver before and during treatment with KISQALI. Tell your health care provider right away if you get any of the following signs and symptoms of liver problems:

yellowing of your skin or the whites of your eyes (jaundice)
dark or brown (tea-colored) urine
feeling very tired
loss of appetite
pain on the right side of your stomach area (abdomen)
bleeding or bruising more easily than normal

Low white blood cell counts (neutropenia). Low white blood cell counts are very common during treatment with KISQALI and may result in infections that may be severe. Your health care provider should check your white blood cell counts before and during treatment with KISQALI. Tell your health care provider right away if you have signs and symptoms of low white blood cell counts or infections such as fever and chills.
Your health care provider may tell you to decrease your dose, temporarily stop, or completely stop taking KISQALI if you develop certain serious side effects during treatment with KISQALI.

What should I tell my health care provider before taking KISQALI?
Before you take KISQALI, tell your health care provider if you:

have any heart problems, including heart failure, irregular heartbeats, and QT prolongation
have ever had a heart attack
have a slow heartbeat (bradycardia)
have problems with the amount of potassium, calcium, phosphorus, or magnesium in your blood
have fever, chills, or any other signs or symptoms of infection
have liver problems
have any other medical conditions
are pregnant, or plan to become pregnant. KISQALI can harm your unborn baby
- If you are able to become pregnant, your health care provider should do a pregnancy test before you start treatment with KISQALI.
- Females who are able to become pregnant and who take KISQALI should use effective birth control during treatment and for at least 3 weeks after the last dose of KISQALI.
- Talk to your health care provider about birth control methods that may be right for you during this time.
- If you become pregnant or think you are pregnant, tell your health care provider right away.
are breastfeeding or plan to breastfeed. It is not known if KISQALI passes into your breast milk. Do not breastfeed during treatment with KISQALI and for at least 3 weeks after the last dose of KISQALI

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. KISQALI and other medicines may affect each other, causing side effects. Know the medicines you take. Keep a list of them to show your health care provider or pharmacist when you get a new medicine.

What should I avoid while taking KISQALI?
Avoid eating grapefruit and avoid drinking grapefruit juice during treatment with KISQALI since these may increase the amount of KISQALI in your blood.
The most common side effects of KISQALI include:

decreased white blood cell counts
decreased red blood cell counts
abnormal liver function tests
infections
nausea
increased kidney function test
tiredness
decreased platelet counts
diarrhea
vomiting
headache
constipation
hair loss
cough
rash
back pain
low blood sugar level

KISQALI may cause fertility problems if you are male and take KISQALI. This may affect your ability to father a child. Talk to your health care provider if this is a concern for you.

Tell your health care provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of KISQALI. For more information, ask your health care provider or pharmacist. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see accompanying full Prescribing Information including Patient Information.

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Breast Cancer V.4.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed [March 24, 2023]. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.