FDA has approved atezolizumab and hyaluronidase-tqjs developed by, Genentech, for subcutaneous injection in all adult indications as the intravenous formulation of atezolizumab, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), hepatocellular carcinoma (HCC), melanoma, and alveolar soft part sarcoma (ASPS).
The subcutaneous injection of atezolizumab and hyaluronidase-tqjs was evaluated in IMscin001, in adult patients with NSCLC who were not previously exposed to cancer immunotherapy and who had disease progression following treatment with platinum-based chemotherapy.
The FDA has also approved a companion diagnostic test, the PD-L1 IHC 22C3 assay, to help identify NSCLC, SCLC, HCC, melanoma, and ASPS patients who may benefit from treatment with atezolizumab and hyaluronidase-tqjs.
The identical active ingredient in both subcutaneous and IV atezolizumab formulations has been reported which led to comparable systemic exposure and similar efficacy for patients with NSCLC, SCLC, HCC, melanoma, and ASPS.
Source: FDA approves atezolizumab and hyaluronidase-tqjs for subcutaneous injection
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-atezolizumab-and-hyaluronidase-tqjs-subcutaneous-injection?utm_medium=email&utm_source=govdelivery
