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News & Trends - Pharmaceuticals

Breast cancer drugs; warning of rare but serious lung inflammation

Health Industry Hub | September 19, 2019 |

The US Food and Drug Administration (FDA) on Friday warned that breast cancer drugs falling in the CDK 4/6 inhibitors class may cause rare but severe inflammation of the lungs that could lead to death.

Ibrance (palbociclib) from Pfizer, Novartis’ Kisqali (ribociclib) and Lilly’s Verzenio (abemaciclib) fall within this class. These therapies are registered in Australia.

The FDA has approved new warnings about this risk to the prescribing information and patient package insert for the entire class of these cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor medicines. The overall benefit of CDK 4/6 inhibitors is still greater than the risks when used as prescribed.

CDK 4/6 inhibitors are a class of prescription medicines that are used in combination with hormone therapies to treat adults with hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative advanced or metastatic breast cancer that has spread to other parts of the body.

“Health care professionals should monitor patients regularly for pulmonary symptoms indicative of interstitial lung disease (ILD) and/or pneumonitis. Signs and symptoms may include hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams in patients in whom infectious, neoplastic, and other causes have been excluded. Interrupt CDK 4/6 inhibitor treatment in patients who have new or worsening respiratory symptoms, and permanently discontinue treatment in patients with severe ILD and/or pneumonitis.” FDA said.

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