FDA issues warning for CDK 4/6 inhibitors in breast cancer

  • FDA

  • curated by Miriam Davis, PhD
  • Univadis Clinical Summaries
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.

Takeaway

  • 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.

Highlights

  • 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:
    • hypoxia,
    • cough,
    • 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.