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Guideline: FDA issues warning on CDK inhibitors

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This study is about:

The U.S. Food and Drug Administration’s () safety alert warning that Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib) may cause a rare but severe inflammation of the lungs.

Why is this study important?

The approved Ibrance in 2015, and both Kisqali and Verzenio in 2017 to treat some patients with advanced breast cancer. These drugs, called CDK 4/6 inhibitors have been shown to significantly improve the amount of time a cancer does not grow and the patient is alive.  However, in some patients they may cause rare but severe lung inflammation


CDK 4/6 inhibitors are a class of prescription medicines that are used in combination with hormone therapies to treat adults with hormone receptor-positive, advanced or breast cancer.

The reviewed cases of lung disease associated with use of CDK 4/6 inhibitors.  Cases were identified from both ongoing and completed clinical trials. Cases were also identified from the ’s drug safety database.

The found that, although rare, there were serious cases and/or deaths with Ibrance (palbociclib), Verzenio (abemaciclib), and Kisqali (ribociclib).

  • Across clinical trials of these three CDK 4/6 inhibitors, 1 to 3 percent of patients had lung inflammation of any grade.
    • Less than 1 percent of these patients had fatal outcomes.
  • Among patients who developed lung inflammation, including fatal cases, there were patients who had no risk factors for lung disease, but some patients had at least one risk factor.


The recommends that anyone taking these CDK inhibitors notify their health care provider if they have any new or worsening symptoms involving their lungs.

Symptoms to watch for include:

  • Difficulty or discomfort with breathing
  • Shortness of breath while at rest or with low activity

What does this mean for me?

Rarely, CDK 4/6 inhibitors can cause severe lung inflammation. However, the benefits of taking these medicines may outweigh this risk. The is urging patients to not stop taking a CDK 4/6 inhibitors without first talking to their health care provider. 

It is important to know:

  • All medicines have side effects even when used correctly as prescribed.
  • People respond differently to all medicines depending on their health, the diseases they have, genetic factors, other medicines they are taking, and many other factors.

Experts do not yet know the factors that make a patient high-risk for severe lung inflammation when taking Ibrance, Kisqali, or Verzenio.

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Posted 9/24/19


warns about rare but severe lung inflammation with Ibrance, Kisqali, and Verzenio for breast cancer. website. Posted September 13, 2019.



FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.

This article is relevant for:

People currently taking a CDK inhibitor

This article is also relevant for:

men with breast cancer

people with ER/PR + cancer

people with a genetic mutation linked to cancer risk

people with breast cancer

people with metastatic or advanced cancer

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Questions To Ask Your Doctor
Questions To Ask Your Doctor

  • Is it safe for me to continue to take my medication (CDK4/6 inhibitors)?
  • I am worried I am risk for lung disease, should I continue to take my medication (CDK 4/6 inhibitor)?
  • Are there other medications that are as effective for me as a CDK 4/6 inhibitor?
  • What signs or symptoms of lung disease should I be looking for?
  • Should I have a chest XRAY or other scan for lung disease?

Open Clinical Trials
Open Clinical Trials

The following studies are looking at management of side effects: 

Multiple cancers

Breast cancer

Colorectal cancer

Endometrial cancer

Ovarian cancer

  • NCT04533763: Living WELL: A Web-Based Program for Ovarian Cancer Survivors. This studies a group-based and web-delivered tool for ovarian cancer survivors in increasing quality of life and decreasing stress, depressive mood, anxiety, and fatigue across a 12-month period.
  • NCT05047926: Prehabilitation for Advanced Ovarian Cancer Patients. Prehabilitation may improve peri-operative outcomes in patients undergoing cancer surgery. This study will look at structured activity for women undergoing chemotherapy to improve their physical state prior to surgical intervention and thus improve outcomes.


Updated: 02/15/2023

Who covered this study?

Targeted Oncology

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