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 Encorafenib Plus Cetuximab and Chemo in BRAF V600E-Positive Metastatic CRC
Published: December 20th 2024 | Updated: December 20th 2024The FDA has granted approval for the use of encorafenib in combination with cetuximab and mFOLFOX6 for the treatment of metastatic colorectal cancer harboring a BRAF V600E mutation.
