The U.S. Food and Drug Administration (FDA) has granted approval for Tecentriq Hybreza, the first and only PD-(L)1 inhibitor for subcutaneous injection, developed by Genentech, a member of the Roche Group. This new formulation offers patients a quicker and more flexible cancer treatment option compared to the standard intravenous (IV) infusion. Tecentriq Hybreza is a combination of atezolizumab and hyaluronidase-tqjs, allowing for administration under the skin in approximately seven minutes, significantly reducing the time spent in clinics compared to the 30 to 60 minutes required for IV infusion.

Subcutaneous Cancer Treatment Option Reduces Time and Enhances Patient Experience

The approval of Tecentriq Hybreza provides an alternative to the intravenous administration of Tecentriq (atezolizumab) for adults in the United States. This new subcutaneous formulation is now available for all previously approved indications of Tecentriq, including various types of lung, liver, skin, and soft tissue cancers.

Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development at Genentech, stated, “By enabling subcutaneous administration for a cancer immunotherapy, Tecentriq Hybreza now offers patients with multiple cancer types and their physicians greater flexibility and choice of treatment administration.” He emphasized that this new option builds on the established safety and efficacy profile of intravenous Tecentriq.

Clinical Trials Show Patient Preference for Subcutaneous Formulation

The FDA’s approval is based on pivotal data from the Phase IB/III IMscin001 study, which demonstrated that the subcutaneous administration of Tecentriq Hybreza provided comparable levels of the drug in the blood, with a safety and efficacy profile consistent with its IV formulation. The Phase II IMscin002 study revealed that 71% of patients preferred Tecentriq Hybreza over the intravenous version, citing reduced time in the clinic, increased comfort, and decreased emotional distress as primary reasons for their preference. Approximately 79% of patients opted to continue with Tecentriq Hybreza after experiencing both formulations.

Ann Fish-Steagall, RN, Senior Vice President of Patient Services at the LUNGevity Foundation, noted, “This approval represents a significant option to improve the patient experience. When patients have options, they feel empowered to be vital participants in their own care and choose their preferred treatment option.”

Expanding Global Access and Options for Cancer Patients

Tecentriq Hybreza’s subcutaneous formulation received its first worldwide approval in Great Britain in August 2023 and is currently approved in over 50 countries. It is marketed as Tecentriq SC outside the United States. Regulatory reviews are ongoing in other countries and regions.

Genentech continues to focus on improving patient experience and supporting individuals living with various illnesses. The introduction of Tecentriq Hybreza complements Genentech and Roche’s portfolio of 13 other subcutaneous therapies available for different diseases, offering additional administration options to meet diverse patient needs.

What is Tecentriq Hybreza?

Tecentriq Hybreza is used to treat several types of cancers, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), hepatocellular carcinoma (HCC), melanoma, and alveolar soft part sarcoma (ASPS). The treatment is tailored based on cancer type, stage, genetic profile, and whether it is combined with other medications.

Important Safety Information

Tecentriq Hybreza can cause the immune system to attack normal organs and tissues, potentially leading to serious or life-threatening conditions. Patients should seek immediate medical attention if they experience symptoms such as cough, shortness of breath, chest pain, severe abdominal pain, yellowing of the skin or eyes, or any other new or worsening symptoms.

Patients with specific conditions, such as autoimmune diseases, organ transplants, or those who have received radiation therapy to the chest, should discuss their medical history with their healthcare provider before receiving Tecentriq Hybreza.

The FDA’s approval of Tecentriq Hybreza as the first subcutaneous anti-PD-(L)1 cancer immunotherapy marks a significant advancement in cancer treatment options. By reducing treatment time and providing a more comfortable administration method, this innovation offers a promising alternative for patients and healthcare providers in the fight against cancer.

  atezolizumab, Cancer immunotherapy, FDA approval, Genentech, Roche, subcutaneous cancer treatment, Tecentriq Hybreza