FDA Warns That Several Breast Cancer Drugs Lead to Lung Inflammation

The U.S. Food and Drug Administration (FDA) issued a warning that three breast cancer drugs, Ibrance® (palbociclib), Kisqali® (ribociclib), and Verzenio® (abemaciclib), may cause rare but severe inflammation of the lungs.

These cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors are approved for the treatment of hormone receptor-positive, human epidermal growth factor 2-negative advanced or metastatic breast cancer.

Monitor patients with respiratory symptoms

Healthcare professionals should regularly monitor patients taking these drugs for pulmonary symptoms that indicate interstitial lung disease (ILD) and/or pneumonitis, such as hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams in patients. These treatments should be interrupted in patients who have new or worsening respiratory symptoms and permanently discontinued in patients with severe ILD and/or pneumonitis.

However, the agency noted, “The overall benefit of CDK 4/6 inhibitors is still greater than the risks when used as prescribed.” The agency’s warning notes that patients should not stop taking these medications without consulting a healthcare professional.

The FDA has approved new warnings about this risk for the prescribing information and patient package insert for the entire drug class.