Keytruda

What Keytruda does

Keytruda is the brand name for pembrolizumab, a humanized monoclonal antibody and PD-1 checkpoint inhibitor developed and marketed by Merck & Co., Inc. (NYSE: MRK) and headquartered in Rahway, New Jersey. It is an FDA-approved immunotherapy that blocks the PD-1/PD-L1 pathway, enabling the immune system to detect and attack cancer cells. The franchise is approved across more than 18 oncology indications in adult and pediatric patients, including non-small cell lung cancer, melanoma, head and neck squamous cell carcinoma, urothelial cancer, MSI-H/dMMR solid tumors, colorectal cancer, gastric and esophageal cancers, cervical cancer, renal cell carcinoma, endometrial carcinoma, cutaneous squamous cell carcinoma, triple-negative breast cancer, and ovarian cancer.

The product portfolio comprises two formulations: KEYTRUDA (intravenous administration) and KEYTRUDA QLEX (subcutaneous injection of pembrolizumab with berahyaluronidase alfa-pmph, administered in 1 to 2 minutes). Both share the same approved indications and pembrolizumab active ingredient, and are positioned as monotherapy or in combination with chemotherapy, targeted agents, or other immunotherapies such as enfortumab vedotin and the personalized cancer vaccine intismeran autogene. The subcutaneous formulation, FDA-approved in 2024, materially reduces administration time and provides a differentiated delivery option for healthcare providers.

Commercially, Keytruda is a prescription-only pharmaceutical sold to oncologists, healthcare providers, and hospital systems, with treatment administered at authorized infusion centers, oncology clinics, and hospitals. Merck supports the franchise through dedicated patient (keytruda.com) and healthcare professional (keytrudahcp.com) websites, downloadable patient and caregiver resources, clinical trial publications, and a patient assistance program. The keytruda.com site is restricted to U.S. residents, indicating a domestic commercial focus for this brand surface. Revenue mechanics follow a unit-pricing model tied to dosing regimen (200 mg every 3 weeks or 400 mg every 6 weeks for IV; 400 mg every 6 weeks for QLEX) and treatment duration, with reimbursement flowing through commercial insurers, Medicare, and Medicaid channels. Keytruda does not have a standalone ownership or capital structure; it is a product brand within Merck's diversified pharmaceutical portfolio.

Name

Keytruda

Legal name

Merck & Co., Inc.

Website

https://keytruda.com

Company type

Public

Operating status

Operating

Short description

Keytruda, a product brand of Merck & Co., Inc., develops and markets pembrolizumab-based PD-1 inhibitor immunotherapy used to treat 18+ cancer types including NSCLC, melanoma, urothelial cancer, and others in adult and pediatric oncology patients in the United States.

Ownership category

akta.pro rank

Product category

Oncology Immunotherapy Pharmaceuticals

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical and Medicine Manufacturing (3254)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)

akta.pro industry

PRIMARYHLAIAIAC

Rare Oncology & Hematologic Malignancy Therapies

Healthcare & Life Sciences/Pharmaceuticals/Orphan & Rare Disease Pharmaceuticals

SECONDARYHLAIACAB

Immunology & Autoimmune Specialty Pharmaceuticals

Healthcare & Life Sciences/Pharmaceuticals/Specialty Pharmaceuticals

Keywords

• Cancer immunotherapy
• Oncology pharmaceuticals
• PD-1 inhibitor drugs
• Monoclonal antibody therapy
• Immuno-oncology treatments

Headquarters

HQ city

Rahway

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Supply Chain, Marketing or Sales, Operations, Personnel, Infrastructure

Revenue model

1. Pharmaceutical Product Sales: KEYTRUDA and KEYTRUDA QLEX are prescription immunotherapies sold to healthcare providers and through pharmacies. Revenue is generated through direct pharmaceutical sales, with pricing based on dosing regimens and treatment duration. Treatment courses vary based on cancer type, stage, and treatment plan prescribed by oncologists.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

Keytruda develops and markets pembrolizumab-based immunotherapy drugs used to treat multiple cancer types in adults and children. Its two FDA-approved products — KEYTRUDA (intravenous) and KEYTRUDA QLEX (subcutaneous) — are PD-1 inhibitors that work by blocking the PD-1/PD-L1 pathway to enable the immune system to detect and attack cancer cells. The products are approved across 18+ oncology indications including melanoma, NSCLC, HNSCC, urothelial cancer, MSI-H/dMMR solid tumors, colorectal, gastric, esophageal, cervical, renal cell, endometrial, cutaneous squamous cell carcinoma, triple-negative breast cancer, and ovarian cancer.

Product overview

Keytruda's product portfolio consists of two FDA-approved immunotherapy products: KEYTRUDA (pembrolizumab) and KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph). KEYTRUDA is administered intravenously, while KEYTRUDA QLEX is a subcutaneous injection formulation that uses berahyaluronidase alfa-pmph to enable rapid subcutaneous delivery. Both products contain the same active ingredient (pembrolizumab), a PD-1 inhibitor that works with the immune system to help fight cancer cells. KEYTRUDA QLEX offers a faster administration alternative (1-2 minutes versus IV infusion time for KEYTRUDA) while maintaining the same approved cancer indications.

Differentiator

Problem solved

Functional benefit

Brands

• KEYTRUDA QLEX: A subcutaneous injection formulation of pembrolizumab combined with berahyaluronidase alfa-pmph, administered in 1 minute every 3 weeks or 2 minutes every 6 weeks.

Products and services

• KEYTRUDA (pembrolizumab) KEYTRUDA is an FDA-approved immunotherapy (pembrolizumab), a humanized monoclonal antibody and PD-1 inhibitor administered intravenously. It works by blocking the PD-1/PD-L1 pathway to enable the immune system to detect and attack cancer cells. It is approved to treat multiple cancer types in adults and children including non-small cell lung cancer (NSCLC), melanoma, head and neck squamous cell cancer (HNSCC), urothelial cancer, MSI-H/dMMR solid tumors, colorectal cancer, gastric cancer, esophageal cancer, cervical cancer, renal cell carcinoma, endometrial carcinoma, cutaneous squamous cell carcinoma, triple-negative breast cancer, and ovarian cancer.
• KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) KEYTRUDA QLEX is an FDA-approved subcutaneous injection formulation combining pembrolizumab with berahyaluronidase alfa-pmph. It is administered just under the skin by a healthcare provider in the stomach area or thigh in 1 minute every 3 weeks or 2 minutes every 6 weeks, offering a faster administration alternative to intravenous KEYTRUDA while maintaining the same approved cancer indications.

Quantifiable outcome

• Combination therapy with cancer vaccine reduced distant metastasis risk by 59% vs Keytruda alone after 5 years in melanoma patients
• +6 more outcomes

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Partnerships

One partnership is on record.

• Intismeran Autogene (Personalized Melanoma Cancer Vaccine)coreStrategic or Co-development Partner · 2 June 2026Phase 2b clinical trial (KEYNOTE-942) testing personalized melanoma cancer vaccine (intismeran autogene) combined with Keytruda in 157 high-risk melanoma patients. The combination therapy demonstrated 59% reduction in distant metastasis risk compared to Keytruda alone after 5 years of follow-up. Overall survival was 92.2% in the combination group versus 71.3% in the Keytruda-only group.

Scale indicators1 record

Recent moves5 records

Expansion highlights4 records

Broad incumbents

• Roche/Genentech: Parent of Tecentriq with broad oncology portfolio across biologics, ADCs (Kadcyla, Polivy), and diagnostics. Direct comparable as a major oncology pharma with checkpoint inhibitor exposure competing with Keytruda.
• Bristol Myers Squibb: Parent of Opdivo and Yervoy; major oncology incumbent with broad IO portfolio including CAR-T (Breyanzi, Abecma), hematology, and immuno-oncology combinations. Comparable as a Keytruda-franchise rival at the parent company level.
• AstraZeneca: Parent of Imfinzi with major oncology franchise including Tagrisso, Enhertu (ADC partnership with Daiichi Sankyo), Lynparza, and Calquence. Competes with Keytruda across multiple oncology indications.

Direct peers

• Libtayo (cemiplimab) - Regeneron/Sanofi: PD-1 inhibitor approved in cutaneous squamous cell carcinoma, NSCLC, basal cell carcinoma, and cervical cancer. Competes with Keytruda in NSCLC and other oncology indications; key emerging PD-1 challenger.
• Jemperli (dostarlimab) - GSK: PD-1 inhibitor approved in endometrial cancer (dMMR) and recently in primary advanced/recurrent endometrial cancer. Competes with Keytruda in MSI-H/dMMR tumors and is being expanded by GSK across new oncology settings.
• Tecentriq (atezolizumab) - Genentech/Roche: PD-L1 inhibitor approved across NSCLC, urothelial, HCC, melanoma adjuvant, and other oncology indications. Competes with Keytruda in overlapping settings and is part of Roche's immuno-oncology franchise.
• Imfinzi (durvalumab) - AstraZeneca: PD-L1 inhibitor approved in NSCLC (stage III, extensive-stage), HCC, biliary tract cancer, and other indications. Competes with Keytruda in curative-intent and advanced lung settings; AstraZeneca is actively expanding Imfinzi's label.
• Opdivo (nivolumab) - Bristol Myers Squibb: Direct PD-1 inhibitor competitor also approved across multiple oncology indications including melanoma, NSCLC, RCC, and urothelial cancer. Head-to-head trials and label overlap make it Keytruda's most direct clinical and commercial rival.

Others

• Merck & Co., Inc. (MRK): Parent company of Keytruda — included as a relevant context reference rather than a true peer. Merck's broader oncology pipeline (WELIREG, lynparza co-promotion) and resources are what underwrite Keytruda's commercial reach.

Emerging players

• Regeneron: Co-developer of Libtayo (with Sanofi); broader oncology pipeline including bispecifics (linvoseltamab) and ADCs. Comparable as an emerging oncology innovator that could disrupt established PD-1 regimens including Keytruda combinations.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Keytruda