News >

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.
... to read the full story
To Read the Full Story

View Conference Coverage
Online CME Activities
TitleExpiration DateCME Credits
Publication Bottom Border
Border Publication
x