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Guideline: FDA issues warning on CDK inhibitors

Summary

The U.S. Food and Drug Administration issued a safety alert for CDK inhibitors, including Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib). (9/24/19)

FDA issues warning on CDK inhibitors

Relevance

This article is most relevant for People currently taking a CDK inhibitor

Relevance Rating Details

Relevance: Medium-High

Research Timeline: Post Approval

Media Ratings

Did you see the media coverage of this article?

See all media ratings.

How we rated the media

Who covered this study?

Targeted Oncology

FDA warns of lung inflammation from CDK4/6 inhibitor use in breast cancers
This article rates 3.5 out of 5 stars

docwire

FDA warns that several breast cancer drugs lead to lung inflammation
This article rates 3.0 out of 5 stars

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Contents

At a glance Questions for your doctor
Findings                              Resources                                 


STUDY AT A GLANCE

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

findings:

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.

Guidelines

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.

Share your thoughts on this XRAYS article by taking our brief survey.

Posted 9/24/19
 

References

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

 

Disclosure

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

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.

cancer

Updated: 08/28/2024

Related Resources
Related Resources

FORCE XRAYS: CDK inhibitor

Medwatch:  Safety Information and Reporting Program

Medwatch: Form for reporting and

 

Related Resources
Related Resources

The following organizations have resources related to treatment side effects. 

Updated: 05/22/2024

Who covered this study?

Targeted Oncology

FDA warns of lung inflammation from CDK4/6 inhibitor use in breast cancers This article rates 3.5 out of 5 stars

docwire

FDA warns that several breast cancer drugs lead to lung inflammation This article rates 3.0 out of 5 stars

Yahoo! Finance

Breast cancer drugs may inflame lungs per FDA safety alert This article rates 3.0 out of 5 stars

Medscape

Breast cancer drugs may severely inflame lungs, FDA warns This article rates 3.0 out of 5 stars

How we rated the media

Back to XRAY Home

Article Rating Details

Targeted Oncology: FDA warns of lung inflammation from CDK4/6 inhibitor use in breast cancers
Rating: 3.5 Stars

  • The article headline matches the research. 
  • The lede is accurate.
  • There were no sources interviewed.
  • The article is clear, but not easy to read for the average reader.

docwire: FDA warns that several breast cancer drugs lead to lung inflammation
Rating: 3.0 Stars

  • The headline is somewhat misleading. There are many breast cancer drugs. The reader is left wondering which of these are the ‘several’ it the headline.
  • The lede is accurate.
  • There were no sources interviewed.
  • The article is clear; but, likely not easy to read for the average reader.

Yahoo! Finance: Breast cancer drugs may inflame lungs per FDA safety alert
Rating: 3.0 Stars

  • The headline is somewhat misleading. There are many breast cancer drugs. The reader is left wondering which of these are the ‘several’ it the headline.
  • The lede is accurate.
  • There were no sources interviewed.
  • The article is clear; but, likely not easy to read for the average reader.

Medscape: Breast cancer drugs may severely inflame lungs, FDA warns
Rating: 3.0 Stars

  • The headline is somewhat misleading. There are many breast cancer drugs.  The reader is left wondering which breast cancer drugs may result in lung inflammation.
  • The lede is accurate.
  • There were no sources interviewed.
  • The article is clear; but, likely not easy to read for the average reader.

Study Rating Details

Relevance: Medium-High

  • This FDA safety alert is most relevant for breast cancer patients currently taking a CDK inhibitor.
  • This safety alert has been issued by the FDA.
  • The FDA issued specific recommendations for people taking CDK 4/6 inhibitors.
  • This is a new warninng on a rare but possible side effect associated with use of CDK inhibitors for the treatment of advanced breast cancer.

Research Timeline:  Post-approval

  • CDK 4/6 inhibitors are clinically used now and have FDA approval.
  • The FDA provided information that is clinically useful about watching for respiratory symptoms in patients on CDK 4/6 inhibitors. 
  • More research will be needed to determine who is most at risk for these complications and the best prevention or treatment.