FDA Approves First Subcutaneous Anti-PD-(L)1 Cancer Immunotherapy

Genentech, a member of the Roche Group, has announced that the U.S. Food and Drug Administration (FDA) has approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), marking it as the first and only PD-(L)1 inhibitor for subcutaneous (SC) injection for cancer patients in the United States. This new method allows Tecentriq Hybreza to be administered under the skin in roughly seven minutes, whereas the traditional intravenous (IV) infusion of Tecentriq (atezolizumab) takes between 30 to 60 minutes.

Tecentriq Hybreza will be available for all adult IV indications of Tecentriq in the U.S., which includes various types of lung, liver, skin, and soft tissue cancers. Levi Garraway, M.D., Ph.D., and chief medical officer at Genentech, emphasized that this new subcutaneous option provides patients and physicians with enhanced flexibility and choice in treatment administration, building on the established safety and efficacy of IV Tecentriq.

The FDA's approval of Tecentriq Hybreza is grounded in pivotal data from the Phase IB/III IMscin001 study. This study showed that subcutaneous administration of Tecentriq resulted in comparable levels of the drug in the blood and demonstrated similar safety and efficacy profiles to the IV formulation. Additionally, findings from the Phase II IMscin002 study revealed that 71% of patients preferred Tecentriq Hybreza over the IV version due to the reduced time spent in the clinic, increased comfort during treatment, and lower emotional distress. Moreover, 79% of patients opted to continue their treatment with Tecentriq Hybreza after experiencing both formats.

Ann Fish-Steagall, RN, from the LUNGevity Foundation, expressed that this new treatment option significantly improves the patient experience by empowering them with the ability to choose their preferred method of treatment.

The subcutaneous formulation of Tecentriq was first approved globally in Great Britain in August 2023 and is now approved in over 50 countries, marketed outside the U.S. as Tecentriq SC. Regulatory reviews in other regions are ongoing. Genentech offers comprehensive services to help minimize barriers to access and reimbursement for individuals prescribed Tecentriq Hybreza.

Tecentriq Hybreza combines Tecentriq with Halozyme Therapeutics' Enhanze drug delivery technology. Tecentriq is a monoclonal antibody designed to bind to PD-L1, a protein expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with PD-1 and B7.1 receptors, thus potentially reactivating T cells. The Enhanze technology uses recombinant human hyaluronidase PH20 (rHuPH20) to increase tissue permeability under the skin, facilitating rapid dispersion and absorption of Tecentriq into the bloodstream.

Tecentriq is approved for several aggressive and challenging forms of cancer, including early-stage non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and hepatocellular carcinoma (HCC), among others. The indications for Tecentriq Hybreza and Tecentriq SC align with those for IV Tecentriq.

Genentech is committed to advancing lung cancer treatments and currently has six approved medicines for different types of lung cancer, along with more than ten medicines in development targeting the most common genetic drivers of lung cancer or boosting the immune system.

Founded over 40 years ago, Genentech is a prominent biotechnology company dedicated to discovering, developing, and manufacturing medicines for serious and life-threatening medical conditions. The company is headquartered in South San Francisco, California.