A First in Immunotherapy – FDA Approves Tecentriq for Subcutaneous Injection

The United States Food and Drug Administration (FDA) announced a groundbreaking development in cancer treatment on September 12, 2024. For the first time, an immunotherapy medicine received FDA approval in a subcutaneous (under-the-skin) formulation: atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza).

This approval offers an important innovation in cancer treatment by allowing the medicine to be administered more quickly and conveniently.

The subcutaneous formulation can be used for all indications of intravenous atezolizumab. These include non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), hepatocellular carcinoma (HCC), melanoma and alveolar soft part sarcoma (ASPS).

Why Does This Approval Matter?

Subcutaneous injection represents a major change in how immunotherapy is administered. Conventional intravenous formulations generally require prolonged hospital visits, while injecting the subcutaneous formulation takes only a few minutes. This improves patient comfort and allows hospital resources to be used more efficiently. It also makes access to treatment substantially easier for patients.

FDA Approval Based on the IMscin001 Trial

Subcutaneous atezolizumab and hyaluronidase-tqjs was evaluated in IMscin001, an open-label, multicenter, international randomized trial. It enrolled 371 patients with locally advanced or metastatic NSCLC who had not previously received immunotherapy and whose disease had progressed after platinum-based chemotherapy. Patients were assigned to two groups receiving subcutaneous atezolizumab and hyaluronidase-tqjs or intravenous atezolizumab.

Efficacy and Safety

The primary objective was pharmacokinetic data assessing how long atezolizumab remains in the body.

• No significant difference was observed between the subcutaneous and intravenous formulations.
• There was also no notable difference between groups in overall response rate, progression-free survival (PFS) or overall survival (OS).
• The confirmed overall response rate was 9% (95% CI: 5%, 13%) in the subcutaneous injection group and 8% (95% CI: 4%, 14%) in the intravenous group.

The most commonly reported side effects were fatigue, musculoskeletal pain, cough, shortness of breath and loss of appetite. These were similar to the side effects previously observed with the intravenous formulation.

Dosage and Administration

Subcutaneous atezolizumab and hyaluronidase-tqjs is administered into the thigh every 3 weeks as a 15 mL injection (1875 mg atezolizumab and 30000 units hyaluronidase). Administration takes approximately 7 minutes, much less time than intravenous treatment.

The Future of This Development

This FDA approval is an important milestone enabling easier and faster delivery of immunotherapy. The subcutaneous formulation is considered a major innovation in making cancer treatments more patient-friendly. It will offer substantial convenience, particularly for patients undergoing intensive treatment. Reduced demand on hospital infrastructure may also benefit healthcare systems.

This new formulation is expected to pave the way for other immunotherapies and open the door to further innovative solutions in cancer treatment.