- The FDA has issued a warning regarding rare but severe postmarketing cases of lung inflammation in patients receiving cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors.
- CKD 4/6 inhibitors are used are used in combination with hormone therapies to treat advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer.
- The announcement did not specify case number or prevalence.
- Prescribing information has been updated for the 3 FDA-approved CDK 4/6 inhibitors: palbociclib, ribociclib, and abemaciclib.
Why this matters
- The FDA asserts that the overall benefits of CDK 4/6 inhibitors still outweigh the risks.
- The FDA advises clinicians to periodically monitor patients for pulmonary symptoms indicative of interstitial lung disease (ILD) and/or pneumonitis, the signs and symptoms of which may include:
- dyspnea, and/or
- interstitial infiltrates on radiologic exam in patients without infectious, neoplastic, or other causes.
- CDK 4/6 inhibitors should be temporarily stopped in patients with new or worsening respiratory symptoms, and permanently stopped for severe ILD and/or pneumonitis.
- FDA encourages clinicians to report cases to its MedWatch Safety Information and Adverse Event Reporting program.