Tagged News
Pertuzumab Regimen Shows Modest Survival Benefit in HER2-Positive Early Breast Cancer
• The APHINITY trial's 6-year analysis reveals that adjuvant pertuzumab with trastuzumab plus chemotherapy improved overall survival by 0.9% in HER2-positive early breast cancer patients, though not reaching statistical significance.
• Patients with node-positive disease showed the most significant benefit from the pertuzumab regimen, with a 4.5% absolute improvement in invasive disease-free survival at 6 years compared to placebo.
• The pertuzumab combination maintained a favorable cardiac safety profile with severe cardiac events occurring in less than 1% of patients, supporting its continued use in high-risk HER2-positive early breast cancer.
FDA Approves Two New Ustekinumab Biosimilars, Bringing Total US Biosimilar Count to 65
• The FDA has approved Biocon's Yesintek (ustekinumab-kfce) and Celltrion's Steqeyma (ustekinumab-stba) in November and December 2024, expanding treatment options for autoimmune conditions including Crohn's disease and psoriasis.
• Of the 65 FDA-approved biosimilars, 14 have received interchangeable designation, allowing pharmacists to substitute them for reference products without prescriber intervention, enhancing patient access to more affordable treatments.
• The biosimilar landscape continues to evolve with products spanning five major classes: insulin, granulocyte colony-stimulating factors, monoclonal antibodies, TNF-alpha inhibitors, and VEGF inhibitors.