The Food and Drug Administration (FDA) is warning healthcare professionals and patients that Ibrance (palbociclib; Pfizer), Kisqali (ribociclib; Novartis), and Verzenio (abemaciclib; Lilly) may cause rare but severe inflammation of the lungs. These agents, which belong to a class of drugs known as cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors, are used in combination with hormone therapies for the treatment of hormone-receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative advanced or metastatic breast cancer

Cases of interstitial lung disease (ILD) and pneumonitis were identified in clinical trials and postmarket safety databases. Across these trials, 1 to 3% of patients had ILD/pneumonitis of any grade and <1% had fatal outcomes; in some cases, patients had no risk factors for lung disease, while others had at least 1 risk factor. “The overall benefit of CDK 4/6 inhibitors is still greater than the risks when used as prescribed,” the FDA stated in a press release.

Based on these findings, the Agency has approved new warnings regarding the risk of ILD/pneumonitis to the prescribing information and Patient Package Insert for the previously mentioned medications and the entire class of CDK 4/6 inhibitors.

Healthcare professionals are being advised to monitor patients regularly for pulmonary symptoms indicative of ILD and/or pneumonitis, including hypoxia, cough, dyspnea, and interstitial infiltrates on radiologic exams. Treatment should be interrupted immediately in patients with new or worsening respiratory symptoms, and permanently discontinued if severe ILD and/or pneumonitis occurs.


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Clinicians and patients can report adverse events associated with these products to the FDA’s MedWatch Program.

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For more information visit FDA.gov.