Immunotherapy Drug Keytruda

General Studies Paper II: Health, Scientific Innovations & Discoveries

Why in News?

Recently, an immunotherapy drug Keytruda was found diverted from hospitals and counterfeited in India, with fake vials sold to desperate patients, exposing regulatory gaps.

What is Keytruda?

About: Keytruda is a revolutionary immunotherapy drug used in treating multiple cancers. Its generic name is pembrolizumab.
- It belongs to a class of immune checkpoint inhibitors that enhance the body’s natural defense system against cancer.
Nature: It is a humanized monoclonal antibody (IgG4 type) designed to target specific immune pathways.
- Unlike chemotherapy, it is categorized under targeted immunotherapy, making treatment more precise.
Developed By: It is manufactured by the U.S.-based global pharmaceutical giant Merck & Co. (known as MSD outside the U.S. and Canada).
Mechanism: Keytruda works by blocking the PD-1 (Programmed Death-1) receptor on T-cells. This prevents cancer cells from evading immune detection, enabling the immune system to recognize and destroy tumors effectively.
Types of Cancer Treated: It is used in melanoma, lung cancer, head and neck cancers, lymphoma, non-small cell lung cancer (NSCLC) and others.
- It is especially effective in advanced or metastatic cancers, where conventional treatments show limited success.
Administration: Keytruda is administered through intravenous (IV) infusion, typically every few weeks under medical supervision.
- In India, it is approved by the Drug Controller General of India (DCGI) for multiple cancer types.
Dosage: The dosage and duration depend on the type and stage of cancer.
- Dosage is determined by body weight, cancer type, and clinical guidelines, making it a personalized therapy.
Recognition: Approved in 2014 in the United States for treatment of unresectable melanoma (a form of skin cancer), Keytruda is listed in the WHO Essential Medicines List, highlighting its importance in modern cancer therapy globally.
Cost: Keytruda is extremely expensive, often costing around ₹1–1.5 lakh per dose in India, making it inaccessible for many patients and increasing dependence on private healthcare systems.
Effectiveness: It is often called a “breakthrough” or “magic drug” because it can significantly improve survival rates in some patients by boosting immune response instead of directly attacking cancer cells.
- It is effective in shrinking tumors and reducing disease burden, often achieving partial or complete remission in various cancer types.
- It creates lasting immune memory in T-cells, this can provide sustained protection and long-term remission, even after treatment has concluded.
Side Effects: Common side effects include fatigue, rash, diarrhea, nausea, and breathing issues.
- As it stimulates immunity, it may also cause Immune-Related Reactions (irAEs) and autoimmune reactions affecting organs like lungs or liver.

Note: Other immunotherapy drugs in India include, Nivolumab (Opdivo), Atezolizumab (Tecentriq), Ipilimumab (Yervoy), and Durvalumab, which treat cancer.

Keytruda in Indian Cancer Treatment

Patient Adoption: In a major Indian center study, 1.61% of the total cancer patient base (155 out of 9,610) received immunotherapy, with Keytruda being a leading choice.
- Hospital data from September 2023 to March 2024 alone showed at least 84 patients received the drug at specific top-tier facilities during that period.
Success Rates: In India, the Objective Response Rate (ORR) for Keytruda is approximately 19.4% across various solid tumors.
- Specialized oncologists at centers like HCG Cancer Centre report higher success, with 40–60% of patients achieving complete or partial remission.
Effectiveness: In clinical settings, Keytruda plus chemotherapy has nearly doubled the median overall survival to 22 months, compared to 10.6 months for chemotherapy alone.
- Real-world Indian data for NSCLC show a clinical benefit rate of 50% in evaluable cohorts.
- It is utilized both as a neoadjuvant (pre-surgery) and adjuvant (post-surgery) treatment to lower the risk of recurrence.
- Since January 2023, Keytruda has been a first-line immunotherapy for cervical cancer in India for patients expressing PD-L1.
- It is also the first approved adjuvant immunotherapy for Renal Cell Carcinoma (RCC), showing significant efficacy in preventing disease progression.

Cancer Burden and Control in India:

Incidence and Projection: India currently ranks third globally in cancer incidence, following China and the USA.
- As of 2024, the country recorded approximately 15.3 lakh new cancer cases.
- Projections by the Indian Council of Medical Research (ICMR) suggest a steady rise to 15.7 lakh cases by 2025 and a staggering 22.1 lakh cases by 2040.
- The incidence is estimated to increase by 12.8% between 2020 and 2025.
Mortality Trends and Survival Rates: Cancer-related deaths are rising faster than new cases in India. Between 2015 and 2024, mortality jumped by 28.6%, from 6.8 lakh to 8.7 lakh deaths.
- The mortality-to-incidence ratio currently stands at 57%, meaning nearly three out of five diagnosed patients succumb to the disease.
- Recent ICMR findings indicate that one in nine Indians faces a lifetime risk of developing cancer.
- The overall lifetime risk across the population is estimated at approximately 11%.
Most Prevalent Cancers: Oral cancer has officially surpassed lung cancer as the most common malignancy among Indian men, accounting for 11.28% of all male cases.
- The top five leading sites for males are lung (10.6%), mouth (8.4%), prostate (6.1%), tongue (5.9%), and stomach (4.8%).
- Among Indian women, breast cancer remains the leading site, accounting for 28.8% of cases.
- The other primary cancers affecting females include cervix (10.6%), ovary (6.2%), corpus uteri (3.7%), and lung (3.7%).
- Notably, breast and cervical cancers alone account for nearly 40% of all female cancer cases.
- Cancer incidence in India starts increasing significantly from age 25.
- The highest number of cases is currently recorded in the 60-64 age group.
Regional Hotspots: Northeast India consistently records the highest cancer incidence rates in the country. Mizoram has the highest lifetime risk at 21.1% for men and 18.9% for women.
- Other high-incidence areas include Aizawl, East Khasi Hills, and Papumpare.
- Urbanised states like Delhi (131 per lakh) and Tamil Nadu (128 per lakh) also show elevated rates compared to rural regions.
Economic Burden: The economic toll of cancer is immense, with GDP losses estimated at US$11 billion in 2020, projected to soar to US$36 billion to US$40 billion by 2030.
- For households, the average out-of-pocket expenditure (OOPE) for treatment is approximately ₹3.3 lakh, often leading to catastrophic health expenditure (CHE) for 61.6% of patients.
Childhood Cancer: India reports an estimated 50,000 to 75,000 new childhood cancer cases annually.
- Among children aged 0-14, lymphoid leukaemia is the leading site, affecting 29.2% of boys and 24.2% of girls.
- The second most common childhood site is the brain and nervous system.
Modifiable Risk Factors: Up to 70% of cancers in India are linked to modifiable risk factors.
- Beyond tobacco and alcohol, emerging risks include obesity, processed foods with preservatives, and environmental pollution.
- Infections such as Human Papillomavirus (HPV), Hepatitis, and Helicobacter pylori also contribute significantly to the national burden.
Government Initiatives: Founded in 1982 and managed by the ICMR-NCDIR, the National Cancer Registry Programme (NCRP) is the backbone of cancer surveillance in India. It now includes data from 43 population-based cancer registries (PBCRs) across 23 states, covering approximately 18% of the Indian population.
- The Union Budget 2025-26 has intensified cancer care by planning 200 Day Care Cancer Centres in district hospitals for the upcoming fiscal year.
- Key programs like Ayushman Bharat (PM-JAY) provide financial protection, while the National Cancer Grid (NCG) standardises oncology care across more than 250 hospitals nationwide.
Breakthrough Research: India is making strides in advanced oncology research with the development of NexCAR19, the country’s first indigenous CAR-T cell therapy.
- This gene therapy represents a significant shift toward providing high-end, affordable solutions for cancer treatment within the domestic healthcare ecosystem.