Drug Profile


Alternative Names: Anti-PD-1 monoclonal antibody - Merck; Humanised monoclonal IgG4 antibody against PD-1 - Merck; Keytruda; Lambrolizumab; MK-3475; SCH-900475

Latest Information Update: 23 Mar 2017

Price : $50

At a glance

  • Originator Merck & Co; The Leukemia & Lymphoma Society
  • Developer Advaxis; Amgen; BioLineRx; Canadian Cancer Trials Group; Dana-Farber Cancer Institute; DNAtrix; Eisai Co Ltd; Eli Lilly; Fox Chase Cancer Center; Genexine; Hoosier Cancer Research Network; ImmunoGen; Incyte Corporation; M. D. Anderson Cancer Center; Massachusetts General Hospital; Memorial Sloan-Kettering Cancer Center; Merck & Co; National Cancer Institute (USA); Northwestern University; Plexxikon; Providence Health & Services; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; TG Therapeutics Inc; University of Alabama; University of Birmingham; University of Pittsburgh; Washington University School of Medicine; Yale University
  • Class Antineoplastics; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action CD274 antigen inhibitors; PDCD 1 protein inhibitors; Programmed cell death 1 ligand 2 protein inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    Gastric cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Head and neck cancer; Malignant melanoma; Non-small cell lung cancer
  • Registered Hodgkin's disease
  • Preregistration Urogenital cancer
  • Phase III Breast cancer; Colorectal cancer; Gastric cancer; Liver cancer; Multiple myeloma; Oesophageal cancer; Renal cell carcinoma
  • Phase II Bladder cancer; Bone cancer; Brain metastases; Diffuse large B cell lymphoma; Endometrial cancer; Fallopian tube cancer; Follicular lymphoma; Germ cell and embryonal neoplasms; Glioblastoma; Glioma; Inflammatory breast cancer; Merkel cell carcinoma; Mesothelioma; Nasopharyngeal cancer; Non-Hodgkin's lymphoma; Ovarian cancer; Pancreatic cancer; Penile cancer; Peritoneal cancer; Prostate cancer; Rectal cancer; Recurrent respiratory papillomatosis; Soft tissue sarcoma; Solid tumours; Thymoma; Thyroid cancer; Type 2 diabetes mellitus
  • Phase I/II Chronic lymphocytic leukaemia
  • Phase I Haematological malignancies; Hepatocellular carcinoma
  • Preclinical Human papillomavirus infections

Most Recent Events

  • 14 Mar 2017 PDUFA action date extended by US FDA to 09/06/2017 for sBLA for Solid tumours
  • 14 Mar 2017 Registered for Hodgkin's disease (Second-line therapy or greater, In adults, In adolescents, In children, In infants) in USA (IV)
  • 14 Mar 2017 Additional safety and efficacy data from the phase II KEYNOTE-087 trial in Hodgkin's lymphoma released by Merck
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