The US Food and Drug Administration (FDA) issued a warning today that the commonly prescribed breast cancer therapies known as cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors may cause rare but severe inflammation of the lungs.

The related products include palbociclib (Ibrance, Pfizer), ribociclib (Kisqali, Novartis), and abemaciclib (Verzenio, Eli Lilly), which are approved for use in patients with hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative advanced or metastatic breast cancer.

Healthcare professionals are advised to monitor patients on these drugs regularly for pulmonary symptoms indicative of interstitial lung disease (ILD) and/or pneumonitis, such as hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams in patients.

Professionals should 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.

Specific risk factors for severe lung inflammation among patients on these drugs have not been identified.

The FDA has approved new warnings about this risk to the prescribing information and patient package insert for this entire class of these kinase inhibitors.

The overall benefit of CDK 4/6 inhibitors is still greater than the risks when used as prescribed, the FDA says. CDK 4/6 inhibitors have been shown to improve patients' progression-free survival.

PS：4th China Pharma IP Summit 2019 (CPIPS2019) organized by Shanghai YIP Events, Supported by Pharma IP Right Research Committee of Chinese Pharmaceutical Association, which will be held on 23rd-25th , Oct at Primus Hotel Shanghai Hongqiao China this year. which presents an unrivalled gathering of in-house patent counsel from established and fledgling pharmaceutical and biotechnology companies coming together to listen to updates on patent prosecution and enforceability from global jurisdictions,

The conference provides delegates with an invaluable opportunity to gain insight into the sector issues of critical current importance; listen to best-in-class case studies; keep abreast of the likely forward impact of key judgements and political jolts; and network with global patent peers.
As a dedicated event to pharmaceutical intellectual property, In the past three years we gathered more than 1000 attendees from relevant government departments, industry associations, global and china local pharma/biotech companies, law firms, IP agencies, IP solution providers and so on. Our topics covered the IP protection in all over the world, include mainly China, Europe, US, Japan, South Korea, India and Emerging Markets. We hope CPIPS could be a good networking and sharing platform for Industry peers, For more information please refer to below and attached agenda or visit conference website: www.pharmaip.cn