KEYTRUDA (pembrolizumab)
KEYTRUDA is indicated for the treatment of Melanoma; Non-Small Cell Lung Cancer; Head and Neck Cancer; Classical Hodgkin Lymphoma; Urothelial Carcinoma; Gastric Cancer; Esophageal Cancer; Cervical Cancer; Hepatocellular Carcinoma; Merkel Cell Carcinoma; Renal Cell Carcinoma; Endometrial Cancer; Cutaneous Squamous Cell Carcinoma; Triple-Negative Breast Cancer; Colorectal Cancer; Biliary Tract Cancer.
How KEYTRUDA Works
Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor on T cells, blocking its interaction with the ligands PD-L1 and PD-L2. Normally, when these ligands bind to the PD-1 receptor, they inhibit T cell proliferation and cytokine production, a mechanism that some tumors use to evade the immune system. By blocking this pathway, pembrolizumab removes the inhibition of the immune response, allowing for an enhanced anti-tumor immune response.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2014-09-04
- PDUFA Date
- 2026-06-19 (24d)
- Patent Cliff
- 2028
- Revenue
- $8.4B (Q4-2025)
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
KEYTRUDA Approval History
What KEYTRUDA Treats
16 indicationsKEYTRUDA is approved for 16 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Melanoma
- Non-Small Cell Lung Cancer
- Head and Neck Cancer
- Classical Hodgkin Lymphoma
- Urothelial Carcinoma
- Gastric Cancer
- Esophageal Cancer
- Cervical Cancer
KEYTRUDA 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
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.
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.
KEYTRUDA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
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 KEYTRUDA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications KEYTRUDA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to KEYTRUDA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1808 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03030378 | NCI-2017-00091 NCI-2017-00091, HCC 17-003 | Ph 1 | active not recruiting | Pembrolizumab and Recombinant Interleukin-12 in Treating Patients With Solid Tumors |
| NCT06770582 | NCI-2025-00008 NCI-2025-00008, NRG-GU014 | Ph 2 | recruiting | Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy Treatment During Radiation Therapy for Bladder Cancer, PARRC Trial |
| NCT04164082 | NCI-2019-07573 NCI-2019-07573, A031803 | Ph 2 | active not recruiting | Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer |
| NCT03244384 AMBASSADOR | NCI-2017-01425 NCI-2017-01425, A031501 | Ph 3 | active not recruiting | Testing MK-3475 (Pembrolizumab) After Surgery for Localized Muscle-Invasive Bladder Cancer and Locally Advanced Urothelial Cancer |
| NCT05422794 | NCI-2022-04956 NCI-2022-04956, DFHCC #22-589 | Ph 1 | recruiting | Testing the Addition of Anti-Cancer Drug, ZEN003694 (ZEN-3694) and PD-1 Inhibitor (Pembrolizumab), to Standard Chemotherapy (Nab-Paclitaxel) Treatment in Patients With Advanced Triple-Negative Breast Cancer |
| NCT07198074 | NCI-2025-06974 NCI-2025-06974, NRG-GY035 | Ph 3 | recruiting | Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer |
| NCT05215340 TROPION-Lung08 | DS1062-A-U304 2021-002555-10, KEYNOTE-C73 | Ph 3 | recruiting | Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations |
| NCT04214067 | NCI-2019-08602 NCI-2019-08602, NRG-GY020 | Ph 3 | active not recruiting | Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to the Usual Radiation Treatment for Newly Diagnosed Early Stage High Intermediate Risk Endometrial Cancer |
| NCT07572123 | NCI-2026-03186 NCI-2026-03186, EA4241 | Ph 2, Ph 3 | not yet recruiting | Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem Cell Transplant Alone for High-risk Patients With Relapsed or Refractory Hodgkin Lymphoma |
| NCT02954874 | NCI-2016-01595 NCI-2016-01595, S1418/BR006 | Ph 3 | active not recruiting | Testing MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer |
| NCT04708418 | NCI-2020-14174 NCI-2020-14174, EA6194 | Ph 2 | active not recruiting | A Study Evaluating Whether Pembrolizumab Alone or in Combination With CMP-001 Improves Efficacy of Treatment in Patients With Operable Melanoma |
| NCT04379596 DG-03 | D967LC00001 2019-004483-22 | Ph 2 | recruiting | Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03) |
| NCT07361510 | CA266-0002 2025-523586-18, U1111-1326-9286 | Ph 3 | recruiting | A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 �� 50%. (ROSETTA Lung-202) |
| NCT06875310 | CA239-0004 CA2390004 | Ph 3 | recruiting | A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4) |
| NCT02359565 | NCI-2015-00130 NCI-2015-00130, PBTC-045 | Ph 1 | active not recruiting | Pembrolizumab in Treating Younger Patients With Recurrent, Progressive, or Refractory High-Grade Gliomas, Diffuse Intrinsic Pontine Gliomas, Hypermutated Brain Tumors, Ependymoma or Medulloblastoma |
| NCT04548752 | NCI-2020-06838 NCI-2020-06838, S2001 | Ph 2 | active not recruiting | Testing the Addition of Pembrolizumab, an Immunotherapy Cancer Drug to Olaparib Alone as Therapy for Patients With Pancreatic Cancer That Has Spread With Inherited BRCA Mutations |
| NCT04165096 results posted | 3475-01C MK-3475-01C, KEYMAKER-U01C | Ph 2 | completed | KEYMAKER-U01 Substudy 3: Efficacy and Safety Study of Pembrolizumab (MK-3475) When Used With Investigational Agents in Participants With Advanced Non-small Cell Lung Cancer (NSCLC), Previously Treated With Anti-programmed Cell Death Receptor Ligand 1 (PD-L1) Therapy (MK-3475-01C/KEYMAKER-U01C) |
| NCT02841748 results posted | IRB15-1632 | Ph 2 | completed | A Randomized, Double-Blind Phase II Study of Adjuvant Pembrolizumab Versus Placebo in Head and Neck Cancers at High Risk for Recurrence- the PATHWay Study |
| NCT07221474 INTerpath-13 | V940-013 V940-013, U1111-1318-2495 | Ph 2 | recruiting | A Study of Intismeran Autogene (V940)/Placebo + Pembrolizumab and Chemotherapy in Metastatic Squamous Non-Small Cell Lung Cancer (V940-013) |
| NCT06422806 | NCI-2023-06412 NCI-2023-06412, EA7222 | Ph 3 | recruiting | Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas |
| NCT05353439 | NCI-2022-03215 NCI-2022-03215, 22-C-0005 | Ph 1 | active not recruiting | Testing of Tazemetostat in Combination With Topotecan and Pembrolizumab in Patients With Recurrent Small Cell Lung Cancer |
| NCT06439836 | NCI-2024-04436 NCI-2024-04436, 10636 | Ph 1 | recruiting | Pembrolizumab Plus CA-4948 for the Treatment of Patients With Progressive Metastatic Urothelial Cancer Despite Prior Immunotherapy |
| NCT04369937 results posted | HCC 19-082 | Ph 2 | completed | HPV-16 Vaccination and Pembrolizumab Plus Cisplatin for "Intermediate Risk" HPV-16-associated Head and Neck Squamous Cell Carcinoma |
| NCT06589804 | NCI-2024-07339 NCI-2024-07339, A092205 | Ph 3 | recruiting | Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment |
| NCT03712605 | NCI-2018-02217 NCI-2018-02217, EA6174 | Ph 3 | active not recruiting | Testing Pembrolizumab Versus Observation in Patients With Merkel Cell Carcinoma After Surgery, STAMP Trial |
| NCT06524544 | NCI-2024-06208 NCI-2024-06208, EA8231 | Ph 3 | recruiting | A Study Comparing the Combination of Pembrolizumab and Sacituzumab Govitean-hziy Versus Standard of Care in the Treatment of Advanced Urothelial Cancer |
| NCT06151574 | 1479-0008 2023-504308-27-00, U1111-1294-1407 | Ph 3 | active not recruiting | Beamion LUNG-2: A Study to Test Whether Zongertinib (BI 1810631) Helps People With Advanced Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment |
| NCT07388550 | 10002294 002294-N | Ph 1 | not yet recruiting | Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I) |
| NCT03304639 results posted | NCI-2017-01817 NCI-2017-01817, A091605 | Ph 2 | completed | Testing the Addition of Radiation Therapy to Immunotherapy for Merkel Cell Carcinoma |
| NCT03793179 | NCI-2018-03695 NCI-2018-03695, EA5163 | Ph 3 | active not recruiting | Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer |
| NCT07061977 | NCI-2025-04695 NCI-2025-04695, NRG-GY037 | Ph 3 | recruiting | Induction Pembrolizumab and Chemotherapy Followed by Pembrolizumab Before Chemoradiation and Pembrolizumab Maintenance Compared to Standard Chemoradiation With Pembrolizumab Followed by Pembrolizumab Maintenance in High-Risk Cervical Cancer |
| NCT02362035 KEYNOTE145 results posted | ACE-LY-005 | Ph 1, Ph 2 | completed | ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies |
| NCT04210115 | 3475-975 MK-3475-975, KEYNOTE-975 | Ph 3 | active not recruiting | Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975) |
| NCT05172258 | NCI-2021-13902 NCI-2021-13902, PHII-216 | Ph 2 | active not recruiting | Testing the Addition of an Anti-cancer Drug, Ipatasertib, to the Usual Immunotherapy Treatment (Pembrolizumab) in Patients With Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck |
| NCT05673200 | NCI-2022-10810 NCI-2022-10810, 10546 | Ph 1 | recruiting | Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer |
| NCT05514990 | 16M-22-1 NCI-2022-06505, 16M-22-1 | Ph 1, Ph 2 | active not recruiting | Bortezomib and Pembrolizumab With or Without Pelareorep for the Treatment of Relapsed or Refractory Multiple Myeloma, AMBUSH Trial |
| NCT06772623 | M24-536 2024-514465-18, 2024-514465-18-00 | Ph 1, Ph 2 | recruiting | Study to Evaluate Adverse Events and Efficacy of Intravenous (IV) Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Adult Participants With Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease, and No Actionable Genomic Alterations |
| NCT05239624 | 21-316 | Ph 2 | recruiting | Enfortumab Vedotin and Pembrolizumab in People With Bladder Cancer |
| NCT06843447 | 5909-003 MK-5909-003, 2024-514674-47-00 | Ph 1, Ph 2 | recruiting | A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003) |
| NCT03854474 | NCI-2019-01035 NCI-2019-01035, ETCTN 10183 | Ph 1, Ph 2 | active not recruiting | Testing the Addition of Tazemetostat to the Immunotherapy Drug, Pembrolizumab (MK-3475), in Advanced Urothelial Carcinoma |
| NCT04267848 | NCI-2020-00751 NCI-2020-00751, A081801 | Ph 3 | recruiting | Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO]) |
| NCT07172256 | 2000036095 | Ph 2 | recruiting | CUE-101with Pembrolizumab for Locally Advanced HPV+HNSCCs |
| NCT05775289 results posted | BO44178 | Ph 2 | active not recruiting | A Study of Tobemstomig Plus Platinum-Based Chemotherapy vs Pembrolizumab Plus Platinum-Based Chemotherapy in Participants With Previously Untreated Non-Small Cell Lung Cancer |
| NCT07061964 | NCI-2025-04663 NCI-2025-04663, S2427 | Ph 2 | recruiting | Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial |
| NCT02298959 | NCI-2014-01984 NCI-2014-01984, 15-703 | Ph 1 | active not recruiting | Testing the PD-1 Antibody, MK3475, Given With Ziv-aflibercept in Patients With Advanced Cancer |
| NCT04746924 results posted | AdvanTIG-302 BGB-A317-A1217-302, CTR20211476/CTR20211464 | Ph 3 | terminated | A Study of Ociperlimab With Tislelizumab Compared to Pembrolizumab in Participants With Untreated Lung Cancer |
| NCT05805501 | BO43936 | Ph 2 | active not recruiting | A Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Participants With Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma |
| NCT03486873 | 3475-587 MK-3475-587, KEYNOTE-587 | Ph 3 | recruiting | Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587) |
| NCT07287917 | AMXT1501-103 | Ph 1, Ph 2 | recruiting | Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors |
| NCT05614739 FORAGER-1 | 18594 J4G-OX-JZVA, 2022-502755-59-00 | Ph 1 | recruiting | FORAGER-1: A Study of LOXO-435 (LY3866288) in Participants With Cancer With a Change in a Gene Called FGFR3 |
Showing 50 of 1808 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
KEYTRUDA FDA Label Details
Indications & Usage
FDA Label (PDF)KEYTRUDA is indicated for the treatment of Melanoma; Non-Small Cell Lung Cancer; Head and Neck Cancer; Classical Hodgkin Lymphoma; Urothelial Carcinoma; Gastric Cancer; Esophageal Cancer; Cervical Cancer; Hepatocellular Carcinoma; Merkel Cell Carcinoma; Renal Cell Carcinoma; Endometrial Cancer; Cutaneous Squamous Cell Carcinoma; Triple-Negative Breast Cancer; Colorectal Cancer; Biliary Tract Cancer.
Pro Intelligence Preview
Deep insights for KEYTRUDA
Revenue Insights
- • Q4-2025: $8.4B
- • Historical trend analysis
Patent Timeline
- • Cliff: 2028
- • Generic/biosimilar risk
Trial Analysis
- • 54 total trials
- • Stage: Stable
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
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