FDA Approves Tecentriq Hybreza (atezolizumab/hyaluronidase) for Multiple Cancers

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FDA Published May 15, 2026 Medically reviewed May 15, 2026 DOI ↗ By Dr. Julia Lee, PhD · Oncology, Genomics & Drug Development

Key Takeaway

Consider Tecentriq Hybreza as a subcutaneous alternative to IV atezolizumab for approved indications, with different dosing and administration.

The FDA has approved Tecentriq Hybreza (atezolizumab/hyaluronidase) for a broad range of cancer indications, including non-small cell lung cancer, small cell lung cancer, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma. This subcutaneous formulation combines the PD-L1 inhibitor atezolizumab with hyaluronidase to facilitate subcutaneous administration. The approval covers both monotherapy and combination regimens across various settings, such as adjuvant treatment for stage II to IIIA NSCLC with PD-L1 expression ≥1%, first-line treatment for metastatic NSCLC with high PD-L1 expression, and first-line treatment for extensive-stage SCLC in combination with chemotherapy. For clinicians, this provides a subcutaneous option that may reduce infusion time and resource use compared to intravenous atezolizumab. However, the label notes that Tecentriq Hybreza has different dosing and administration than intravenous atezolizumab and should not be given intravenously.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Atezolizumab is a programmed death-ligand 1 (PD-L1) blocking antibody. Hyaluronidase is an endoglycosidase that degrades hyaluronan, increasing tissue permeability to facilitate subcutaneous delivery.

Indication & Patient Population

Tecentriq Hybreza is indicated for: - NSCLC: adjuvant treatment after resection and platinum-based chemotherapy for stage II to IIIA with PD-L1 ≥1%; first-line monotherapy for metastatic NSCLC with high PD-L1 (TC ≥50% or IC ≥10%) and no EGFR/ALK aberrations; first-line in combination with bevacizumab, paclitaxel, and carboplatin for metastatic non-squamous NSCLC without EGFR/ALK aberrations; first-line in combination with paclitaxel protein-bound and carboplatin for metastatic non-squamous NSCLC without EGFR/ALK aberrations; treatment of metastatic NSCLC after platinum-based chemotherapy (with EGFR/ALK aberrations must have progressed on targeted therapy). - SCLC: first-line in combination with carboplatin and etoposide for ES-SCLC; maintenance in combination with lurbinectedin after first-line induction with Tecentriq Hybreza or IV atezolizumab plus carboplatin/etoposide. - HCC: in combination with bevacizumab for unresectable or metastatic HCC without prior systemic therapy. - Melanoma: in combination with cobimetinib and vemurafenib for BRAF V600 mutation-positive unresectable or metastatic melanoma. - ASPS: monotherapy for unresectable or metastatic ASPS in adults and pediatric patients ≥12 years weighing ≥40 kg.

Dosing & Administration

Tecentriq Hybreza is for subcutaneous use in the thigh only. Do not administer intravenously. The recommended dosage for adults and pediatric patients (≥12 years, ≥40 kg) is 15 mL (1,875 mg atezolizumab and 30,000 U hyaluronidase).

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Tecentriq Hybreza provides a subcutaneous alternative to intravenous atezolizumab for multiple approved indications, potentially reducing administration time and healthcare resource utilization. It is not interchangeable with IV atezolizumab and requires specific dosing.

Study Details

Study typeFda approval

PublishedSep 2024

View Original Abstract ↓

1 INDICATIONS AND USAGE TECENTRIQ HYBREZA is a combination of atezolizumab, a programmed death-ligand 1 (PD-L1) blocking antibody, and hyaluronidase, an endoglycosidase indicated: Non-Small Cell Lung Cancer (NSCLC) as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage II to IIIA NSCLC whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test. ( 1.1 ) for the first-line treatment of adult patients with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. ( 1.1 ) in combination with bevacizumab, paclitaxel, and carboplatin, for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations. ( 1.1 ) in combination with paclitaxel protein-bound and carboplatin for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations. ( 1.1 ) for the treatment of adult patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving TECENTRIQ HYBREZA. ( 1.1 ) Small Cell Lung Cancer (SCLC) in combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). ( 1.2 ) in combination with lurbinectedin, for the maintenance treatment of adult patients with ES-SCLC whose disease has not progressed after first-line induction therapy with TECENTRIQ HYBREZA or intravenous atezolizumab, and carboplatin plus etoposide. ( 1.2 ) Hepatocellular Carcinoma (HCC) in combination with bevacizumab for the treatment of adult patients with unresectable or metastatic HCC who have not received prior systemic therapy. ( 1.3 ) Melanoma in combination with cobimetinib and vemurafenib for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma as determined by an FDA-approved test. ( 1.4 ) Alveolar Soft Part Sarcoma (ASPS) for the treatment of adult patients and pediatric patients (12 years of age and older who weigh 40 kg or greater) with unresectable or metastatic ASPS. ( 1.5 ) 1.1 Non-Small Cell Lung Cancer TECENTRIQ HYBREZA, as monotherapy, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage II to IIIA [see Clinical Studies (14.1) ] non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test [see Dosage and Administration (2.1) ]. TECENTRIQ HYBREZA, as monotherapy, is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]) , as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations [see Dosage and Administration (2.1) ]. TECENTRIQ HYBREZA, in combination with bevacizumab, paclitaxel, and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations. TECENTRIQ HYBREZA, in combination with paclitaxel protein-bound and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations. TECENTRIQ HYBREZA, as monotherapy, is indicated for the treatment of adult patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving TECENTRIQ HYBREZA. 1.2 Small Cell Lung Cancer TECENTRIQ HYBREZA, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). TECENTRIQ HYBREZA, in combination with lurbinectedin, is indicated for the maintenance treatment of adult patients with ES-SCLC whose disease has not progressed after first-line induction therapy with TECENTRIQ HYBREZA or intravenous atezolizumab, carboplatin and etoposide. 1.3 Hepatocellular Carcinoma TECENTRIQ HYBREZA, in combination with bevacizumab, is indicated for the treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy. 1.4 Melanoma TECENTRIQ HYBREZA, in combination with cobimetinib and vemurafenib, is indicated for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma as determined by an FDA-approved test [see Dosage and Administration (2.1) ] . 1.5 Alveolar Soft Part Sarcoma TECENTRIQ HYBREZA, as monotherapy, is indicated for the treatment of adult patients and pediatric patients (12 years of age and older who weigh 40 kg or greater) with unresectable or metastatic alveolar soft part sarcoma (ASPS).