Subcutaneous Tecentriq Hybreza Approved

FDA has approved a subcutaneous injectable formulation of Genentech’s Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) for all the adult indications as the product’s intravenous formulation, including non-small cell lung cancer (NSCLC), small cell lung cancer, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma.

Approval was based on data from the IMscin001 (NCT03735121) randomized trial in adult patients with locally advanced or metastatic NSCLC who were not previously exposed to cancer immunotherapy and who had disease progression following treatment with platinum-based chemotherapy,” an agency release says. It says 371 patients were randomized (2:1) to receive a subcutaneous or intravenous dosage until disease progression or unacceptable toxicity. No “notable differences” in objective response rate, progression free survival, or overall survival were observed between the different formulations, FDA says.