MedPath

FDA Approves Roche's Tecentriq Hybreza, a Subcutaneous Anti-PD-(L)1 Cancer Immunotherapy

• The FDA has approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) as the first subcutaneous PD-(L)1 inhibitor for cancer immunotherapy. • Tecentriq Hybreza offers a faster administration time of approximately seven minutes compared to the 30-60 minutes required for intravenous Tecentriq. • This subcutaneous formulation maintains the established safety and efficacy profile of intravenous Tecentriq across its approved indications. • Tecentriq Hybreza is now approved for all IV indications of Tecentriq in the U.S., covering certain lung, liver, skin, and soft tissue cancers.

The U.S. Food and Drug Administration (FDA) has approved Roche's Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), marking the first subcutaneous (SC) PD-(L)1 inhibitor for cancer immunotherapy. This new formulation offers a more convenient and faster administration option for patients across various cancer types.
Tecentriq Hybreza is administered subcutaneously via injection in approximately seven minutes, significantly reducing the administration time compared to the 30-60 minutes required for the standard intravenous (IV) infusion of Tecentriq (atezolizumab). The approval covers all IV indications of Tecentriq approved for adults in the U.S., including specific types of lung, liver, skin, and soft tissue cancers.

Clinical Impact and Patient Experience

According to Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development, Tecentriq Hybreza provides patients and physicians with greater flexibility and choice of treatment administration. The subcutaneous formulation builds upon the established safety and efficacy profile of intravenous Tecentriq while offering a faster and more accessible treatment option.
Ann Fish-Steagall, RN, senior vice president of Patient Services at the LUNGevity Foundation, emphasized the importance of patient choice, stating, "When patients have options, they feel empowered to be vital participants in their own care and choose their preferred treatment option."

Global Availability and Regulatory Status

The subcutaneous formulation of Tecentriq received its first worldwide approval in Great Britain in August 2023 and is now approved in 50 countries (marketed as Tecentriq SC outside the U.S.). Regulatory reviews are ongoing in other countries and regions.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

FDA Approves Novel Therapies for Synovial Sarcoma, Cutaneous T-Cell Lymphoma, and Subcutaneous Atezolizumab

The FDA granted accelerated approval to Tecelra (afamitresgene autoleucel), a T-cell receptor therapy, for inoperable or metastatic synovial sarcoma, marking the first TCR therapy for solid tumors.
Lymphir (denileukin diftitox), a novel immunotherapy targeting the IL-2 receptor on malignant T cells, received FDA approval for relapsed or refractory cutaneous T-cell lymphoma.

FDA Approves Subcutaneous Tecentriq Hybreza for Multiple Cancer Types

The FDA has approved Tecentriq Hybreza, a subcutaneous formulation of atezolizumab, for various cancer indications, offering a new administration route.
Approval was based on the IMscin001 trial, which demonstrated comparable atezolizumab exposure between subcutaneous and intravenous administrations.

FDA Approves Roche's Tecentriq Hybreza, a Subcutaneous PD-L1 Inhibitor, for Multiple Cancers

The FDA has approved Roche's Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), a subcutaneous formulation, for multiple cancer types previously approved for the IV form.
Tecentriq Hybreza, combining atezolizumab with Halozyme's Enhanze technology, offers a faster, approximately 7-minute injection compared to the 30-60 minute IV infusion.

Roche's Subcutaneous Tecentriq Approved; Gilead's HIV Shot Shows Promise

The FDA approved Roche's Tecentriq Hybreza, the first checkpoint inhibitor available as a subcutaneous injection, offering a faster administration time of about seven minutes.
Gilead's twice-yearly lenacapavir HIV shot reduced infection risk by 96% in a Phase 3 trial, leading to halted trial and plans for regulatory filings and a potential 2025 launch.

FDA Approves Roche's Injectable Ocrevus for Multiple Sclerosis

The FDA has approved Roche's subcutaneous injectable version of Ocrevus for treating multiple sclerosis, offering a quicker 7-minute administration time.
The approval was based on the OCARINA II trial, demonstrating non-inferiority to the intravenous formulation regarding drug levels and similar safety profiles.

FDA Approves Genentech's Tecentriq Hybreza, First Subcutaneous Anti-PD-(L)1 Immunotherapy

The FDA has approved Tecentriq Hybreza, a subcutaneous formulation of atezolizumab, marking the first subcutaneous anti-PD-(L)1 cancer immunotherapy in the U.S.
Tecentriq Hybreza reduces treatment time to approximately 7 minutes via subcutaneous injection, compared to 30-60 minutes for intravenous infusion.

FDA Approves Subcutaneous Atezolizumab (Tecentriq Hybreza) for Multiple Cancer Types

The FDA has approved a subcutaneous formulation of atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) for all indications of intravenous atezolizumab.
This includes non-small cell lung cancer, small cell lung cancer, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma.

FDA Approves Tepylute, a Ready-to-Dilute Thiotepa Formulation, for Breast and Ovarian Cancer

The FDA has approved Tepylute, a ready-to-dilute formulation of thiotepa, for treating breast and ovarian cancer, addressing limitations of the previous powder form.
Tepylute simplifies drug preparation, enhances dosing accuracy, and reduces healthcare personnel's exposure to this hazardous drug during handling.

Keytruda Receives 40th FDA Approval for Advanced Endometrial Cancer Treatment

The FDA has approved pembrolizumab (Keytruda) combined with chemotherapy for treating adult patients with primary advanced or recurrent endometrial cancer, marking its 40th approval. This milestone underscores Keytruda's role in revolutionizing cancer treatment by enhancing the immune system's ability to fight tumors.

Reference News

[1]
FDA approves Roche's Tecentriq Hybreza, the first and only subcutaneous anti-PD-(L) cancer ...
indianpharmapost.com · Sep 16, 2024

FDA approves Roche’s Tecentriq Hybreza, the first subcutaneous anti-PD-(L) cancer immunotherapy, offering greater treatm...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy