MHRA Issues New Safety Warnings for CDK4/6 Inhibitors

Pavankumar Kamat

June 22, 2021

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a drug safety update for cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6 inhibitors) inhibitors, highlighting the risk of interstitial lung disease and pneumonitis, including severe cases.

CDK4/6 inhibitors (abemaciclib, palbociclib and ribociclib) have been approved for the treatment of hormone receptor-positive-, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant.

Review of safety data identified cases of interstitial lung disease and pneumonitis with the use of CDK4/6 inhibitors, including some fatal cases. In the UK, suspected adverse reports of interstitial lung disease, pneumonitis and related terms reported were eight for abemaciclib (4 fatal), 18 for palbociclib (7 fatal) and one for ribociclib.

Clinicians should ask patients using CDK4/6 inhibitors regarding new or worsening pulmonary symptoms suggestive of interstitial lung disease and pneumonitis, including cough or dyspnoea, and tell them to seek prompt medical advice if they occur. Clinicians may consider dose interruption, modification or discontinuation based on the severity of the event.

In clinical trials of abemaciclib and palbociclib, the frequency of interstitial lung disease or pneumonitis of any grades of severity in trial participants was 3.4% and 1.4%. For ribociclib, interstitial lung disease of any grade occurred in 0.3% of ribociclib-treated participants and pneumonitis of any grade in 0.4% of both the ribociclib and the placebo-treated participants.

The Summary of Product Characteristics and the Patient Information Leaflet for the drugs are being updated to reflect the information regarding these risks.

References: CDK4/6 inhibitors (abemaciclib, palbociclib, ribociclib): reports of interstitial lung disease and pneumonitis, including severe cases. Medicines and Healthcare products Regulatory Agency. 2021 June 17.

This article originally appeared on Univadis, part of the Medscape Professional Network.


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