On September 12, 2024, the Food and Drug Administration approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech, Inc.) for subcutaneous injection for all the adult indications as the intravenous formulation of atezolizumab (Tecentriq, Genentech, Inc.), including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), hepatocellular carcinoma (HCC), melanoma, and alveolar soft part sarcoma (ASPS). See the prescribing information for the specific indications.
Full prescribing information for Tecentriq Hybreza will be posted on Drugs@FDA.
Efficacy and Safety
The subcutaneous injection of atezolizumab and hyaluronidase-tqjs was evaluated in IMscin001 (NCT03735121), an open-label, multi-center, international, 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. A total of 371 patients were randomized (2:1) to receive subcutaneous atezolizumab and hyaluronidase-tqjs or intravenous atezolizumab until disease progression or unacceptable toxicity.
The primary outcome measure was atezolizumab exposure, with coprimary pharmacokinetic (PK) endpoints of Cycle 1 Ctrough and AUC0-21days. Additional descriptive efficacy outcome measures were overall response rate (ORR), progression-free survival (PFS), and overall survival (OS). The geometric mean ratio (GMR) (90% CI) of subcutaneous atezolizumab and intravenous atezolizumab for Cycle 1 Ctrough was 1.05 (0.88, 1.24) and AUC0-21days was 0.87 (0.83, 0.92), which met the lower limit of the GMR (90% CI) above the pre-specified threshold of 0.8 for comparability. No notable differences in ORR, PFS or OS were observed between the different formulations. The confirmed ORR was 9% (95% CI: 5, 13) in the subcutaneous atezolizumab and hyaluronidase-tqjs arm and 8% (95% CI: 4, 14) in the intravenous atezolizumab arm.
The most common adverse reactions of any grade (≥ 10%) were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite.
The recommended dosage is one 15 mL injection (containing 1,875 mg of atezolizumab and 30,000 units of hyaluronidase) administered subcutaneously in the thigh over approximately 7 minutes every 3 weeks.
Expedited Programs
This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.
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