• Regulatory NewsRegulatory News

    Three Breast Cancer Drugs: FDA Warns of Rare but Serious Lung Inflammation

    The US Food and Drug Administration (FDA) on Friday warned that breast cancer drugs, Ibrance (palbociclib) from Pfizer, Novartis' Kisqali (ribociclib) and Lilly's Verzenio (abemaciclib) may cause rare but severe inflammation of the lungs that could lead to death. “We have 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 bene...
  • Regulatory NewsRegulatory News

    Australia and Canada Jointly Approve Breast Cancer Drug

    As part of a push toward regulatory convergence, Health Canada and Australia’s Therapeutic Goods Administration (TGA) last week jointly approved Eli Lilly’s Verzenio (abemaciclib) for the treatment of metastatic breast cancer. Each regulator evaluated different parts of the regulatory submission dossier, although both made independent decisions regarding approval. Health Canada also worked with the Canadian Agency for Drugs and Technologies in Health (CADTH) on the appr...