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FDA warns about rare but severe lung inflammation with Ibrance, Kisqali, and Verzenio for breast cancer

FDA Drug Safety Podcast

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Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information.

On September 13, 2019, FDA warned that Ibrance (active ingredient palbociclib), Kisqali (active ingredient ribociclib), and Verzenio (active ingredient abemaciclib) used to treat some patients with advanced breast cancers may cause rare but severe inflammation of the lungs. We have approved new warnings about this risk to the prescribing information and Patient Package Insert for the entire class of these cyclin-dependent kinase (CDK 4/6) inhibitor medicines. The overall benefit of CDK 4/6 inhibitors is still greater than the risks when used as prescribed.

CDK 4/6 inhibitors are a class of prescription medicines that are used in combination with hormone therapies to treat adults with hormone receptor (HR)-positive, human epidermal growth factor 2 (or HER2)-negative advanced or metastatic breast cancer that has spread to other parts of the body. CDK 4/6 inhibitors block certain molecules involved in promoting the growth of cancer cells. FDA approved Ibrance in 2015, and both Kisqali and Verzenio in 2017. CDK 4/6 inhibitors have been shown to improve progression-free survival or the amount of time after the start of treatment the cancer does not grow substantially, and the patient is alive.

Health care professionals should monitor patients regularly for pulmonary symptoms indicative of interstitial lung disease (ILD) and/or pneumonitis. Signs and symptoms may include hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams in patients in whom infectious, neoplastic, and other causes have been excluded. Interrupt CDK 4/6 inhibitor treatment in patients who have new or worsening respiratory symptoms, and permanently discontinue treatment in patients with severe ILD and/or pneumonitis.

We reviewed CDK 4/6 inhibitors cases from completed and ongoing clinical trials undertaken by manufacturers and their postmarket safety databases that described specific types of inflammation of the lungs, or interstitial lung disease, and pneumonitis. Across the entire drug class, there were reports of serious cases, including fatalities.

To help FDA track safety issues with medicines, we urge patients and health care professionals to report side effects involving these or other medicines to the FDA MedWatch program at www.fda.gov/medwatch.

A link to the full communication detailing specific information for health care professionals, the complete Data Summary and a list of FDA-approved CDK 4/6 Inhibitors can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

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