FDA approves atezolizumab and hyaluronidase-tqjs for subcutaneous injection

Regulatory approval: On Sept 12, 2024, the FDA approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) for subcutaneous injection for all adult indications held by IV atezolizumab (Tecentriq), including NSCLC, SCLC, HCC, melanoma, and ASPS. Approval was supported by IMscin001, which met prespecified pharmacokinetic comparability criteria versus IV atezolizumab in previously treated, locally advanced/metastatic NSCLC; descriptive efficacy outcomes appeared similar between formulations.

FDA approval (Sept 12, 2024)

The FDA approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza; Genentech) for subcutaneous injection for all adult indications of IV atezolizumab (Tecentriq), including NSCLC, SCLC, HCC, melanoma, and alveolar soft part sarcoma (ASPS). Clinicians are directed to the prescribing information for indication-specific details; full prescribing information is expected on Drugs@FDA.

Supporting evidence: IMscin001 (NCT03735121)

IMscin001 was an open-label, multicenter, international, randomized trial in adults with locally advanced/metastatic NSCLC, not previously exposed to cancer immunotherapy, with progression after platinum-based chemotherapy. A total of 371 patients were randomized 2:1 to subcutaneous atezolizumab/hyaluronidase-tqjs vs IV atezolizumab until progression or unacceptable toxicity.

  • Primary outcome: atezolizumab exposure (coprimary PK endpoints Cycle 1 Ctrough and AUC0–21 days).
  • PK comparability met prespecified criteria: Cycle 1 Ctrough GMR 1.05 (90% CI 0.88–1.24); AUC0–21 days GMR 0.87 (90% CI 0.83–0.92), with lower CI bounds above 0.8.
  • Descriptive efficacy: no notable differences in ORR/PFS/OS; confirmed ORR 9% (95% CI 5–13) SC vs 8% (95% CI 4–14) IV.

Safety and dosing

Common adverse reactions (any grade, ≥10%): fatigue, musculoskeletal pain, cough, dyspnea, decreased appetite. Recommended dosage: 15 mL (atezolizumab 1,875 mg + hyaluronidase 30,000 units) SC in the thigh over ~7 minutes every 3 weeks.

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