Data updated: May 26, 2026
TECENTRIQ HYBREZA (atezolizumab and hyaluronidase-tqjs)
Programmed Death Receptor-1-directed Antibody Interactions Genetically Validated
Oncology
Approved 2024-09-12
TECENTRIQ HYBREZA is indicated for the treatment of Non-Small Cell Lung Cancer.
How TECENTRIQ HYBREZA Works
Atezolizumab binds to PD-L1 on tumor cells and immune cells, preventing it from interacting with PD-1 and B7.1 receptors on T-cells. This blockade releases the inhibition of the immune system, allowing for the activation of anti-tumor immune responses, including increased T-cell activity and proliferation. The hyaluronidase component functions by depolymerizing hyaluronan, a polysaccharide in the subcutaneous tissue's extracellular matrix. This action transiently increases the permeability of the subcutaneous tissue, facilitating the local delivery and absorption of the medication.
4
Indications
--
Phase 3 Trials
3
Priority Reviews
1
Years on Market
Details
- Status
- Prescription
- First Approved
- 2024-09-12
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
TECENTRIQ HYBREZA Approval History
2025
2026
Original
New Indication
New Form
Label Update
7 FDA actions from 2024 to 2026 · 3 indication expansions
May 2026 SUPPL Priority
Efficacy
What TECENTRIQ HYBREZA Treats
1 indicationsTECENTRIQ HYBREZA is approved for 1 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Non-Small Cell Lung Cancer
Source: FDA Label
TECENTRIQ HYBREZA Target & Pathway
ProTarget
An immune checkpoint receptor on T-cells that acts as an 'off switch' for immune responses. Cancer cells often exploit PD-1 by expressing its ligands (PD-L1/PD-L2), allowing tumors to evade immune detection. Blocking PD-1 releases this brake, enabling T-cells to recognize and attack cancer cells.
Pathway Context
PD-1 on T-cells binds to PD-L1/PD-L2 on tumor cells, suppressing immune attack
PD-L1 (Programmed Death-Ligand 1) ligand
A protein expressed on tumor cells and immune cells that binds to PD-1 on T-cells, suppressing immune responses. Many cancers overexpress PD-L1 to avoid immune attack. Blocking PD-L1 prevents this immune suppression, allowing the body's T-cells to fight cancer.
PD-L2 (Programmed Death-Ligand 2) ligand
A second ligand for PD-1, expressed on antigen-presenting cells and some tumors. PD-L2 binds PD-1 with higher affinity than PD-L1 but is less widely expressed. Drugs blocking PD-1 prevent both PD-L1 and PD-L2 interactions.
TECENTRIQ HYBREZA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
5
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
8
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
Unlock 17 more competitors across all three rings.
Upgrade to Pro Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in TECENTRIQ HYBREZA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TECENTRIQ HYBREZA treats. First-in-class if their pivotal trials read out positive.
Tiragolumab MTIG7192A / RG6058 ~ Mixed — Ph3 readout
Hoffmann-La Roche TIGIT · monoclonal antibody (anti-TIGIT) · 10 Phase 3 trials
Ceralasertib AZD6738 ~ Mixed — Ph3 readout
AstraZeneca ATR · small-molecule ATR kinase inhibitor · 2 Phase 3 trials
Uliledlimab TJ004309
TJ Biopharma Co., Ltd. NT5E · monoclonal antibody (anti-CD73) · 1 Phase 3 trial
Drugs Similar to TECENTRIQ HYBREZA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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Clinical Trial Registry
541 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05286801 | NCI-2022-01992 NCI-2022-01992, PEPN2121 | Ph 1, Ph 2 | active not recruiting | Tiragolumab and Atezolizumab for the Treatment of Relapsed or Refractory SMARCB1 or SMARCA4 Deficient Tumors |
| NCT02862275 | NCI-2016-01232 NCI-2016-01232, PJC-023 | Ph 1 | active not recruiting | Atezolizumab in Treating Patients With Cancer Following Adoptive Cell Transfer |
| NCT04334941 | NCI-2020-02093 NCI-2020-02093, S1929 | Ph 2 | active not recruiting | Testing Maintenance Therapy for Small Cell Lung Cancer in Patients With SLFN11 Positive Biomarker |
| NCT03141684 | NCI-2016-01040 NCI-2016-01040, CC 17-C-0074 | Ph 2 | active not recruiting | Testing Atezolizumab Alone or Atezolizumab Plus Bevacizumab in People With Advanced Alveolar Soft Part Sarcoma |
| NCT05211323 | NCI-2022-00151 NCI-2022-00151, EA2205 | Ph 2 | active not recruiting | A Study to Determine Whether Chemotherapy and Atezolizumab is Better Than Chemotherapy, Bevacizumab and Atezolizumab in Patients With Advanced Liver Cancer |
| NCT01810913 | NCI-2013-00500 NCI-2013-00500, RTOG-1216 | Ph 2, Ph 3 | recruiting | Testing Docetaxel-Cetuximab or the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy and Radiation Therapy in High-Risk Head and Neck Cancer |
| NCT07388524 | NCI-2026-00505 NCI-2026-00505, A082302 | Ph 3 | not yet recruiting | Testing the Impact of an Anti-Cancer Drug, Atezolizumab, After Surgery to Prevent Early Stage Non-small Cell Lung Cancer From Returning, AASI-NSCLC Trial |
| NCT02849496 | NCI-2016-01130 NCI-2016-01130, 1608018258 | Ph 2 | active not recruiting | Testing Olaparib Either Alone or in Combination With Atezolizumab in BRCA Mutant Non-HER2-positive Breast Cancer |
| NCT05333458 | NCI-2022-03217 NCI-2022-03217, 000726 | Ph 2 | recruiting | Testing Atezolizumab With Selinexor in People ≥ 12 Years Old With Alveolar Soft Part Sarcoma, The AXIOM Trial |
| NCT06287775 | NCI-2024-01398 NCI-2024-01398, 10629 | Ph 1, Ph 2 | recruiting | Testing the Combination of an Anti-cancer Drug, Iadademstat, With Other Anti-cancer Drugs (Atezolizumab or Durvalumab) at Improving Outcomes for Small Cell Lung Cancer |
| NCT03237780 | NCI-2017-01388 NCI-2017-01388, PHII-150 | Ph 2 | active not recruiting | Atezolizumab With or Without Eribulin Mesylate in Treating Patients With Recurrent Locally Advanced or Metastatic Urothelial Cancer |
| NCT04981509 | NCI-2021-07744 NCI-2021-07744, 22-C-0004 | Ph 2 | recruiting | Testing of Bevacizumab, Erlotinib, and Atezolizumab in Combination for Advanced-Stage Kidney Cancer |
| NCT04214262 | NCI-2019-08627 NCI-2019-08627, S1914 | Ph 3 | active not recruiting | Testing the Addition of the Drug Atezolizumab to the Usual Radiation Treatment for Patients With Early Non-small Cell Lung Cancer |
| NCT04402788 | NCI-2020-03472 NCI-2020-03472, NRG-LU007 | Ph 2, Ph 3 | recruiting | Testing the Addition of Radiation Therapy to the Usual Immune Therapy Treatment (Atezolizumab) for Extensive Stage Small Cell Lung Cancer, The RAPTOR Trial |
| NCT03321643 | NCI-2017-01957 NCI-2017-01957, PHI-96 | Ph 1 | active not recruiting | Testing the Addition of an Immunotherapy Agent, Atezolizumab, When Given With the Usual Chemo-Immunotherapy Drug Combination (Rituximab Plus Gemcitabine and Oxaliplatin) for Relapsed/Refractory (That Has Come Back or Not Responded to Treatment) Transformed Diffuse Large B-Cell Lymphoma |
| NCT04310020 | NCI-2020-01543 NCI-2020-01543, S1933 | Ph 2 | active not recruiting | Study of Radiation Therapy Followed by Atezolizumab in Stage II or III Non-small Cell Lung Cancer Patients |
| NCT07155174 SEZanne | M24-633 2024-517490-24 | Ph 2 | recruiting | A Study to Evaluate the Optimal Dose, Adverse Events and Change in Disease Activity of Intravenous ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Adult Participants With Previously Untreated Extensive Stage Small Cell Lung Cancer |
| NCT05063552 | NCI-2021-10021 NCI-2021-10021, EA3202 | Ph 2, Ph 3 | active not recruiting | Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers |
| NCT05836584 | NCI-2023-03192 NCI-2023-03192, EA2212 | Ph 2 | active not recruiting | Testing Immunotherapy (Atezolizumab) With or Without Chemotherapy in Locoregional MSI-H/dMMR Gastric and Gastroesophageal Junction (GEJ) Cancer |
| NCT05411081 | NCI-2022-04668 NCI-2022-04668, S2200 | Ph 2 | active not recruiting | Testing Cabozantinib With or Without Atezolizumab in Patients With Advanced Papillary Kidney Cancer, PAPMET2 Trial |
| NCT05058651 | NCI-2021-09851 NCI-2021-09851, S2012 | Ph 2, Ph 3 | recruiting | Evaluating the Addition of the Immunotherapy Drug Atezolizumab to Standard Chemotherapy Treatment for Advanced or Metastatic Neuroendocrine Carcinomas That Originate Outside the Lung |
| NCT02997228 | NCI-2016-01961 NCI-2016-01961, NRG-GI004/S1610 | Ph 3 | active not recruiting | Testing the Addition of Atezolizumab to Combination Chemotherapy or Atezolizumab Alone for Metastatic Colon or Rectal Cancer, the COMMIT Study |
| NCT05001880 | NCI-2021-08573 NCI-2021-08573, A092001 | Ph 2 | recruiting | Chemotherapy With or Without Immunotherapy for Peritoneal Mesothelioma |
| NCT03337698 Morpheus Lung results posted | BO39610 2017-001267-21 | Ph 1, Ph 2 | terminated | A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer) |
| NCT06077500 DAREONᵀᴹ-8 | 1438-0008 | Ph 1 | active not recruiting | DAREONᵀᴹ-8: A Study to Test How Well Different Doses of BI 764532 in Addition to Standard of Care Are Tolerated by People With Advanced Small Cell Lung Cancer |
| NCT05862285 UmbrellaMAX | BX44273 2022-003414-36, 2023-504263-16-00 | Ph 3 | recruiting | A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study |
| NCT04245085 ABC-lung results posted | ETOP 15-19 MO40586 | Ph 2 | completed | ABC-lung: Atezolizumab, Bevacizumab and Chemotherapy in EGFR-mutant Non-small Cell Lung Carcinoma |
| NCT06496568 | CO43909 2021-006618-36 | Ph 1 | active not recruiting | A Study Evaluating Single-agent Inavolisib, Inavolisib Plus Atezolizumab, and Inavolisib Plus Pembrolizumab in PIK3CA-Mutated Cancers |
| NCT07472517 | 1438-0012 2025-520565-51-00, U1111-1317-4955 | Ph 3 | recruiting | DAREON ® -Lung-1: A Study in People With Advanced Small Cell Lung Cancer to Compare Obrixtamig Plus Atezolizumab, Carboplatin, and Etoposide Treatment With Standard Chemotherapy |
| NCT04802759 | CO42867 2020-004889-19, 2023-507495-48-00 | Ph 1, Ph 2 | recruiting | A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer |
| NCT05968326 IMCODE003 | GO44479 2022-502404-73-00 | Ph 2 | recruiting | A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC |
| NCT06646276 | CA245-0001 | Ph 3 | recruiting | A Study to Compare the Efficacy and Safety of BMS-986489 (BMS-986012+ Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide to That of Atezolizumab With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS). |
| NCT05581004 | GO43860 2021-006708-34, 2023-504709-35-00 | Ph 1 | recruiting | A Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors |
| NCT06921785 ARTEMIDE-HCC01 | D7029C00001 | Ph 3 | recruiting | Phase III Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment of Hepatocellular Carcinoma |
| NCT04262154 results posted | 19-461 | Ph 2 | active not recruiting | Study of Abiraterone Acetate or Enzalutamide, Atezolizumab, GnRH Analog and Radiation Therapy in Men With Newly Diagnosed Hormone-sensitive Prostate Cancer |
| NCT06632327 | CTIU2317-A082304-S2402 NCI-2024-06356 | Ph 3 | recruiting | Comparing Impact of Treatment Before or After Surgery in Patients With Stage II-IIIB Resectable Non-small Cell Lung Cancer |
| NCT04589845 | BO41932 2020-001847-16, 2023-507418-28-00 | Ph 2 | active not recruiting | Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study |
| NCT07291076 | CA266-0006 2025-523602-33, U1111-1327-4912 | Ph 1, Ph 2 | recruiting | A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC) (ROSETTA HCC-206) |
| NCT05498896 BARBICAN | 012418QM 2018-000977-62 | Ph 2 | active not recruiting | Investigate the Contribution of Ipatasertib to Neoadjuvant Chemotherapy Plus Atezolizumab in TNBC |
| NCT07227597 | 6070-003 MK-6070-003, U1111-1318-5025 | Ph 1, Ph 2 | recruiting | A Clinical Study of Gocatamig (MK-6070) and Infinatamab Deruxtecan (MK-2400) in People With Small Cell Lung Cancer (MK-6070-003) |
| NCT07195695 | 1479-0032 U1111-1320-6149, 2025-521284-12-00 | Ph 3 | recruiting | Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations |
| NCT03784326 | 2018-0678 NCI-2018-02828, 2018-0678 | Ph 2 | active not recruiting | Phase I/II Study of Perioperative Chemotherapy Plus Immunotherapy Followed by Surgery in Localized Esophageal and Gastroesophageal Adenocarcinoma |
| NCT05681039 | 2022-0446 NCI-2022-10637 | Ph 2 | recruiting | Phase 2 Trial of Neoadjuvant and Adjuvant Tiragolumab Plus Atezolizumab in Patients With Newly Diagnosed PD-L1 CPS Positive Resectable Stage 3-4 Oral Cavity Squamous Cell Carcinoma (OCSCC). |
| NCT04896697 | XTX101-01/02-001 | Ph 1, Ph 2 | active not recruiting | Vilastobart (XTX101) Monotherapy and Vilastobart and Atezolizumab Combination Therapy in Advanced Solid Tumors |
| NCT05394337 | 2021-0928 NCI-2022-04565 | Ph 1, Ph 2 | recruiting | Neoadjuvant PD-1 Plus TIGIT Blockade in Patients With Cisplatin-Ineligible Operable High-Risk Urothelial Carcinoma |
| NCT04665843 SKYSCRAPER-09 results posted | BO42533 2020-002852-19 | Ph 2 | completed | A Study of Atezolizumab Plus Tiragolumab and Atezolizumab Plus Placebo as First-Line Treatment in Participants With Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck |
| NCT02912559 results posted | NCI-2016-01417 NCI-2016-01417, A021502 | Ph 3 | active not recruiting | Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair |
| NCT07166406 | NRG-GI012 NCI-2025-05951, NRG-GI012 | Ph 3 | recruiting | Testing Immunotherapy With or Without Stereotactic Body Radiation Therapy in Patients With Advanced Liver Cancer, HELIO-RT Trial |
| NCT06031441 | GO44431 2023-509266-38-00 | Ph 1 | recruiting | A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors |
| NCT03554083 results posted | MC1776 NCI-2018-01018, MC1776 | Ph 2 | completed | Vemurafenib, Cobimetinib, Atezolizumab, and Tiragolumab in Treating Patients With High-Risk Stage III Melanoma |
Showing 50 of 541 trials
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TECENTRIQ HYBREZA FDA Label Details
Indications & Usage
FDA Label (PDF)TECENTRIQ HYBREZA is indicated for the treatment of Non-Small Cell Lung Cancer.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.