Pembrolizumab (Keytruda)

From - A Hematology Oncology Wiki
Jump to: navigation, search

General information

Class/mechanism: PD-1 antibody. Pembrolizumab is a humanized monoclonal antibody which binds to the PD-1 receptor on T-cells. In some cancers, the PD-1 ligands are upregulated, which results in inhibition of T-cell immune surveillance of tumors. By blocking the interaction between the PD-1 receptor and its ligands PD-L1 and PD-L2, pembrolizumab decreases this immune system inhibition and facilitates anti-tumor immune response.[1][2][3]
Route: IV
Extravasation: no information

For conciseness and simplicity, currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]

Diseases for which it is used

Patient drug information

Management checklist

  • CBC, comprehensive metabolic panel, Mg, Phos, LDH, TSH. Consider baseline EKG and troponin.

History of changes in FDA indication


Bladder cancer

Cervical cancer

  • 6/12/2018: Approved for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. (New disease indication)

Colorectal cancer

Cutaneous squamous cell carcinoma

Endometrial cancer

Esophageal cancer

  • 7/30/2019: Approved for patients with recurrent, locally advanced or metastatic, squamous cell carcinoma of the esophagus (ESCC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10), as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy. (New disease indication)

Gastric or gastroesophageal junction adenocarcinoma

Classical Hodgkin lymphoma (cHL)

Head and neck squamous cell carcinoma

Hepatocellular carcinoma


Merkel cell carcinoma

MSI-H or dMMR tumors (tissue-agnostic)

Non-small cell lung cancer

Primary mediastinal B-cell lymphoma

Renal cell carcinoma

Small cell lung cancer

TMB-H (tissue agnostic)

  • 6/16/2020: Accelerated approval for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. (New disease-agnostic indication)

Triple-negative breast cancer (TNBC)

  • 11/13/2020: Accelerated approval in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10) as determined by an FDA approved test. (New disease indication)

Also known as

  • Code names: MK-3475, SCH 900475
  • Generic names: lambrolizumab
  • Brand name: Keytruda