FDA Approves Subcutaneous Use of Atezolizumab and Hyaluronidase-tqjs
The agency approved the subcutaneous injection of atezolizumab and hyaluronidase-tqjs for all of the adult indications as the intravenous formulation of atezolizumab.
The FDA has approved the subcutaneous injection of atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) for use in all adult indications as the intravenous formulation of atezolizumab (Tecentriq), including non–small cell lung cancer (NSCLC), small cell lung cancer (SCLC), hepatocellular carcinoma (HCC), melanoma, and alveolar soft part sarcoma (ASPS).
The regulatory decision was supported by data from the phase 3 IMscin001 trial (NCT03735121). Findings showed that the geometric mean ratio (GMR) of subcutaneous atezolizumab and intravenous atezolizumab for Cycle 1Ctrough was 1.05 (90% CI, 0.88-1.24) in patients with with locally advanced or metastatic NSCLC. The AUC0-21days was 0.87 (90% CI, 0.83-0.92).
Data for overall response rate (ORR), progression-free survival (PFS), and overall survival (OS) were similar for the subcutaneous and IV formulations.
The most common any-grade adverse effects reported in at least 10% of patients were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite.
FDA Approves Adjuvant Ribociclib Plus AI Therapy for HR+, HER2- Breast Cancer
September 17th 2024The Food and Drug Administration approved ribociclib plus an aromatase inhibitor for hormone receptor (HR)–positive, HER2-negative stage II and III early breast cancer that has a high risk of recurrence.
