Medscape September 16, 2024
The US Food and Drug Administration (FDA) has approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech, Inc.) as a subcutaneous injection in adults, covering all approved indications of the intravenous (IV) formulation.
Approved indications include non–small-cell lung cancer (NSCLC), small-cell lung cancer, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma. Specific indications are available with the full prescribing information at Drugs@FDA.
This is the first programmed death–ligand 1 inhibitor to gain approval for subcutaneous administration.
“This approval represents a significant option to improve the patient experience,” Ann Fish-Steagall, RN, Senior Vice-president of Patient Services at the LUNGevity Foundation stated in a Genentech press release.
Subcutaneous atezolizumab and hyaluronidase-tqjs was evaluated in in the open-label, randomized IMscin001 trial of 371 adult patients...