KEYTRUDA
Keytruda (pembrolizumab) is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of several types of cancer, including melanoma, non-small cell lung cancer (NSCLC), and malignant pleural mesothelioma. It is utilized in various clinical settings, ranging from first-line treatment for metastatic disease to neoadjuvant and adjuvant therapy for resectable tumors. The drug is approved for use as a single agent or in combination with chemotherapy, depending on the specific cancer type, stage, and the presence of biomarkers such as PD-L1.
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.
Details
- Status
- Prescription
- First Approved
- 2014-09-04
- 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 Competitors
Pro10 other drugs also target PD-1. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (PD-1). Earlier expiry dates signal biosimilar/generic opportunities.
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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
ProIndications & Usage
FDA Label (PDF)KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated: Melanoma for the treatment of patients with unresectable or metastatic melanoma. for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection. Non-Small Cell Lung Cancer (NSCLC) in combination with pemetrexed and platinum chemotherapy, as first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations. in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.