# Pembrolizumab

Source: https://nuclide.cc/drugs/pembrolizumab/  
Nuclide record `pembrolizumab` (Agent). Data CC BY-NC 4.0, attribute "Data from Nuclide (nuclide.cc)"; commercial use needs a licence.

## TL;DR

Pembrolizumab is a PD-1 blocking antibody approved in more than 40 settings, from melanoma and lung cancer to the first tumour-agnostic approval for mismatch-repair-deficient tumours in 2017, and before and after surgery in triple-negative breast cancer. A subcutaneous form arrived in 2025, and it is the backbone partner for ADCs and personalised neoantigen vaccines.

## Summary

Approvals span melanoma, NSCLC, head and neck, Hodgkin, urothelial, MSI-H/dMMR tumours (first tumour-agnostic approval, 2017), gastric, oesophageal, cervical, HCC, RCC, endometrial, TNBC (KEYNOTE-355 metastatic CPS ≥10; KEYNOTE-522 neoadjuvant/adjuvant with 7-year OS benefit), TMB-high, and more. 2026 additions include platinum-resistant PD-L1+ ovarian cancer, adjuvant RCC with belzutifan, and combination labels with sacituzumab govitecan (ASCENT-04) and enfortumab vedotin. Subcutaneous Keytruda Qlex approved 2025. Backbone for neoantigen vaccines (intismeran).

## Fields

- Kind: Agent
- Status: approved
- Last checked: 2026-09-04
- Brand: Keytruda / Keytruda Qlex (SC)
- Modality: Monoclonal antibody (anti-PD-1)
- Mechanism: Humanised IgG4 blocking PD-1; restores T-cell effector function.
- Approvals: US 2014: Melanoma (first of >40 indications); US 2017: MSI-H/dMMR solid tumours (tumour-agnostic); US 2020: Metastatic TNBC, PD-L1 CPS ≥10, with chemotherapy; US 2021: High-risk early TNBC, neoadjuvant + adjuvant (KEYNOTE-522); US 2026: Platinum-resistant PD-L1+ ovarian cancer; adjuvant RCC with belzutifan; with sacituzumab govitecan in 1L TNBC
- Dosing: IV infusion over 30 min (subcutaneous Keytruda Qlex available); 200 mg every 3 weeks or 400 mg every 6 weeks; paediatric 2 mg/kg (max 200 mg) every 3 weeks; up to 24 months in most metastatic settings

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Pembrolizumab
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Pembrolizumab

## Connected records

- indications: [Hepatocellular carcinoma](https://nuclide.cc/indications/hcc/), [Intermediate hepatocellular carcinoma (BCLC B)](https://nuclide.cc/indications/hcc-intermediate/), [Metastatic castration-resistant prostate cancer](https://nuclide.cc/indications/prostate-mcrpc/), [Neuroendocrine and small-cell prostate cancer](https://nuclide.cc/indications/prostate-nepc/), [Prostate cancer](https://nuclide.cc/indications/prostate/), [Renal cell carcinoma](https://nuclide.cc/indications/rcc/), [Thyroid cancer](https://nuclide.cc/indications/thyroid/)
- companies: [Alpha Tau Medical](https://nuclide.cc/companies/alpha-tau-medical/), [Merck & Co. (MSD)](https://nuclide.cc/companies/merck/)
- institutions: [Institut Jules Bordet](https://nuclide.cc/institutions/institut-jules-bordet/), [Johns Hopkins Hospital / Sidney Kimmel Comprehensive Cancer Center](https://nuclide.cc/institutions/johns-hopkins/)
- drugs: [Lead-212 PSV359](https://nuclide.cc/drugs/pb-212-psv359/)
- ideas: [Adding a checkpoint inhibitor to PSMA radioligand therapy](https://nuclide.cc/ideas/idea-rlt-plus-checkpoint-inhibitor/)
- trials: [PRINCE](https://nuclide.cc/trials/prince-trial/)

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