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FDA Issues Warning on Severe Lung Inflammation With CDK4/6 Inhibitors in Breast Cancer

Jason M. Broderick @jasoncology
Published: Friday, Sep 13, 2019

The FDA is updating the prescribing information and Patient Package Insert for the CDK4/6 inhibitors palbociclib (Ibrance), ribociclib (Kisqali), and abemaciclib (Verzenio) to include a warning that the treatments in rare cases may cause severe inflammation of the lungs.1

Other AEs included hot flashes, nausea, leukopenia, and joint pain/stiffness. The most common (≥5%) grade 3/4 AEs in patients receiving ribociclib combination therapy compared to endocrine therapy alone were neutropenia (60.6% vs 3.6%) and leukopenia (14.3% vs 1.2%).

Abemaciclib is approved for use in combination was an aromatase inhibitor as a frontline therapy for patients with HR-positive/HER2-negative advanced or metastatic breast cancer. In the second-line setting, the agent is approved for use with fulvestrant after disease progression on endocrine therapy. The CDK4/6 inhibitor also has a third indication as a monotherapy for patients who progress after endocrine therapy and prior chemotherapy in the metastatic setting.
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