Data updated: May 26, 2026
TECENTRIQ (atezolizumab)
Programmed Death Receptor-1-directed Antibody Interactions Genetically Validated
Trial Activity: Stable 261 active trials
First-in-Class Breakthrough Therapy Priority Review Accelerated Approval Fast Track
Oncology
Approved 2016-05-18
TECENTRIQ is indicated for the treatment of Non-Small Cell Lung Cancer; Small Cell Lung Cancer.
How TECENTRIQ Works
Atezolizumab is a monoclonal antibody that targets and binds to PD-L1, a protein expressed on tumor cells and immune cells that inhibits the body’s anti-tumor immune response. By blocking the interaction of PD-L1 with PD-1 and B7.1 receptors on T cells, the drug prevents the suppression of cytotoxic T-cell activity and proliferation. This blockade releases the inhibition of the
Development Insights
Hoffmann-La Roche conducting 134 trials (24%)
841 indications explored (Broad Platform)
→ non-small cell lung cancer (39 trials)
→ hepatocellular carcinoma (26 trials)
→ colorectal cancer (17 trials)
25
Indications
--
Phase 3 Trials
20
Priority Reviews
10
Years on Market
Details
- Status
- Prescription
- First Approved
- 2016-05-18
- PDUFA Date
- 2026-12-03 (191d)
- Patent Cliff
- 2031
- Revenue
- $1.1B (Q4-2025)
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
TECENTRIQ Approval History
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
42 FDA actions from 2016 to 2026 · 23 indication expansions
May 2026 SUPPL Priority
Efficacy
What TECENTRIQ Treats
2 indicationsTECENTRIQ is approved for 2 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Non-Small Cell Lung Cancer
- Small Cell Lung Cancer
Source: FDA Label
TECENTRIQ 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 Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
2
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
2
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 8 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's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TECENTRIQ 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
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
IMFINZI
DURVALUMAB
AstraZeneca
Shared indications:
Non-Small Cell Lung CancerSmall Cell Lung Cancer
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Clinical Trial Registry
551 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 |
| NCT02314481 DARWINII | 14/0274 | Ph 2 | completed | Deciphering Antitumour Response and Resistance With INtratumour Heterogeneity |
| 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 |
Showing 50 of 551 trials
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Completed studies with published results, ranked by significance
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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 FDA Label Details
Indications & Usage
FDA Label (PDF)TECENTRIQ is indicated for the treatment of Non-Small Cell Lung Cancer; Small Cell Lung Cancer.
Pro Intelligence Preview
Deep insights for TECENTRIQ
Revenue Insights
- • Q4-2025: $1.1B
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • Generic/biosimilar risk
Trial Analysis
- • 560 total trials
- • Stage: Stable
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Unlock Full Intelligence
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment