Development History of

“The President’s Drug”

2006
Collaboration begins between Organon and
Medical Research Council Technology to 2007
humanize pembrolizumab. Schering-Plough acquires Organon.

2009
Merck & Co. acquires Schering-Plough. Early 2010
Merck terminates pembrolizumab development.

Late 2010
Reactivation of pembrolizumab development
after promising results from Bristol Myers 2011
Squibb's checkpoint inhibitors. Phase I clinical trial begins, enrolling
around 1300 patients.
2013
Pembrolizumab receives breakthrough
therapy designation from the FDA. The Sep 2014
USAN name changes to pembrolizumab. FDA approves pembrolizumab for
advanced melanoma under Fast Track.
Jul 2015
Pembrolizumab receives marketing
approval in the European Union. Oct 2015
FDA approves pembrolizumab for
metastatic NSCLC in PD-L1
Aug 2016 positive patients.
FDA grants accelerated approval for
pembrolizumab in recurrent or May 2017
metastatic HNSCC. Pembrolizumab receives FDA
approval for tumors with DNA
Jun 2018 mismatch repair deficiencies or
microsatellite instability-high state.
FDA approves pembrolizumab for
advanced cervical cancer (PD-L1 Nov 2018
positive) and PMBCL. FDA grants accelerated approval for
pembrolizumab in HCC after
Feb 2019 sorafenib treatment.
FDA approves pembrolizumab for
adjuvant treatment of melanoma with Jun 2019
lymph node involvement. FDA grants accelerated approval for
metastatic SCLC and first-line
Jul 2019 HNSCC treatment.
FDA approves pembrolizumab for
ESCC with PD-L1 expression.
Jun 2020
FDA approves pembrolizumab for
TMB-H solid tumors.
Mar 2021
FDA removes SCLC indication.
Jan 2024
FDA approves pembrolizumab with
chemoradiotherapy for FIGO Stage
III-IVA cervical cancer.
Maryam-Daneshpour
 $27,000M
(projected)

$25,000M

Sales & FDA Approvals $20,937M

Trajectory
$17,186M

$14,380M

$11,084M

$7,171M

$3,809M

$1,402M
$55M $566M

2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
Advanced Advanced Non- Recurrent or Classical Hodgkin Previously Treated Adjuvant BCG- Combination with Treatment of Adjuvant Treatment Combination with
Melanoma Small Cell Lung Metastatic Head Lymphoma (cHL), Patients with Treatment of Unresponsive, Platinum and MSI-H/dMMR Following Surgical Chemoradiotherap
Cancer (NSCLC), and Neck First-Line Recurrent or Patients with High-Risk, Non- Fluoropyrimidine- Advanced Resection and y for FIGO 2014
Advanced Squamous Cell Combination Metastatic Melanoma Muscle Invasive Based Endometrial Platinum-Based Stage III-IVA
Melanoma Carcinoma Therapy for Cervical Cancer, Following Bladder Cancer, Chemotherapy for Carcinoma Chemotherapy for Cervical Cancer
(Expanded (HNSCC), First- Metastatic Refractory or Complete Additional Dose of Locally Advanced or Non-Small Cell
Indication) Line Treatment of Nonsquamous Relapsed Primary Resection, 400 mg Every Six Metastatic Lung Cancer
Metastatic NSCLC, Locally Mediastinal Large Combination with Weeks, Treatment Esophageal or (NSCLC), Full
NSCLC Advanced or B-Cell Lymphoma Inlyta for First- of Patients with Gastroesophageal Approval for Certain
Metastatic (PMBCL), Line Treatment of Recurrent or Junction (GEJ) Adult and Pediatric
Urothelial Metastatic Advanced Renal Metastatic Carcinoma, First- Patients with
Carcinoma, First Nonsquamous Cell Carcinoma Cutaneous Line Treatment with Advanced MSI-H
Cancer Treatment NSCLC with No (RCC), First-Line Squamous Cell Trastuzumab and or dMMR Solid
for Any Solid EGFR or ALK Treatment of Carcinoma, First- Chemotherapy for Tumors,
Tumor with a Genomic Tumor Head and Neck Line Treatment of HER2-Positive Combination with
Specific Genetic Aberrations Squamous Cell Unresectable or Gastric or GEJ Padcev for First-
Feature, (Expanded Carcinoma, Metastatic MSI- Adenocarcinoma, Line Treatment of
Previously Treated Label), Treatment of H or dMMR Expanded Indication Certain Patients
Patients with Combination with Metastatic Small Colorectal Cancer, for Locally with Locally
Recurrent Locally Chemotherapy for Cell Lung Cancer Expanded Advanced Advanced or
Advanced or First-Line (SCLC), Indication for Cutaneous Metastatic
Metastatic Gastric Treatment of Recurrent Locally Relapsed or Squamous Cell Urothelial Cancer,
or Metastatic Advanced or Refractory Carcinoma (cSCC), Treatment of
Gastroesophageal Squamous Metastatic Classical Hodgkin Combination with Patients with
Junction Cancer NSCLC, Squamous Cell Lymphoma (cHL), Lenvima for Certain Resectable NSCLC
Treatment of Carcinoma of the Combination with Types of Advanced in Combination with
Hepatocellular Esophagus, Chemotherapy for Endometrial Chemotherapy as
Carcinoma (HCC), Combination with Locally Recurrent Carcinoma, High- Neoadjuvant
Treatment of Lenvima for Unresectable or Risk Early-Stage Treatment, Then
Patients with Certain Types of Metastatic Triple- Triple-Negative Single Agent as
Recurrent Locally Endometrial Negative Breast Breast Cancer in Adjuvant Treatment
Advanced or Carcinoma Cancer Combination with After Surgery,
Metastatic Merkel Chemotherapy, Combination with
Cell Carcinoma Combination for Gemcitabine and
First-Line Cisplatin for Locally
Treatment of Advanced
Advanced Renal Unresectable or
Cell Carcinoma Metastatic Biliary
(RCC), Tract Cancer,
Combination with Combination with
Chemotherapy for Chemotherapy as
Persistent, First-Line
Recurrent or Treatment for
Metastatic Cervical Locally Advanced
Cancer, Adjuvant Unresectable or
Therapy for Certain Metastatic HER2-
Patients with Renal Negative Gastric or
Cell Carcinoma GEJ
(RCC) Adenocarcinoma,
Combination with
Padcev for
Advanced Bladder
Cancer

Maryam-Daneshpour
 Patent Reproduced from

Wall

Maryam-Daneshpour