The immune cancer drug 'Keytruda (ingredient name pembrolizumab)' from MSD in the U.S. recorded the highest pharmaceutical sales last year. Keytruda is expected to be available in a subcutaneous injection (SC) formulation in October this year. Instead of receiving intravenous therapy for several hours, patients will be able to administer the drug through a subcutaneous injection in just a few minutes.
MSD noted on March 27 (local time) at the European Lung Cancer Conference (ELCC) held in Paris, France, that it plans to launch Keytruda's SC formulation in the U.S. in October and in Europe in early 2026. It is expected that the U.S. Food and Drug Administration (FDA) will approve Keytruda SC by the end of September 2025.
Keytruda was first approved by the FDA in September 2014 and was launched in South Korea in April 2015. Since then, additional indications for various types of cancer have been added, and it is now used to treat a variety of cancers, including non-small cell lung cancer, head and neck cancer, bladder cancer, cervical cancer, triple-negative breast cancer, and gastric cancer. It is the world's best-selling prescription drug, with sales reaching approximately $25 billion (about 36.7 trillion won) in 2023 and approximately $29.5 billion (about 43.3 trillion won) in 2024.
Keytruda is an immune cancer drug that targets the protein PD-1 on the surface of T cells. This protein regulates whether T cells attack normal cells; however, cancer cells exploit it to evade the immune system. Keytruda helps activate the immune function of T cells by blocking PD-1, allowing them to recognize and attack cancer cells.
Majorie Green, senior vice president at MSD, said, "Ten years ago, Keytruda was approved as the first anti-PD-1 therapy in the U.S. and has played a significant role in treating the deadliest types of cancer." She noted that the five-year survival rate for patients diagnosed with lung cancer in the U.S. in 2024 is 25%, showing an improvement of more than 20% compared to five years ago.
He said, "Global pharmaceutical companies, including MSD, are developing new drugs that can treat early-stage cancers and new cancers," and noted, "For innovative cancer therapies like Keytruda to emerge, continuous investment in research and development is essential." The following is a Q&A.
What level of efficacy does Keytruda have in treating cancer?
"Keytruda has been approved for 41 indications (specific cancers or conditions that can be treated with specific treatments or drugs) for 18 types of cancer in the U.S. As of April 2025, it has received approval for a total of 34 indications for 18 types of cancer in South Korea. Since being approved as the first anti-PD-1 therapy in the U.S. ten years ago, it has played a significant role in changing the way deadly cancers are treated. Keytruda is a great example of how far cancer treatment has progressed. The five-year survival rate for lung cancer patients diagnosed in the U.S. in 2024 is 25%, which represents an improvement of more than 20% over the past five years."
Will Keytruda also be the top-selling cancer treatment this year? What other cancer drugs has MSD developed?
"Representative examples include 'belzutifan (brand name Welireg)', the first drug to treat tumors associated with von Hippel-Lindau disease, 'lenvatinib (brand name Lenvima)', developed in strategic partnership with Eisai to treat thyroid cancer and hepatocellular carcinoma, and 'olaparib (brand name Lynparza)', developed in strategic partnership with AstraZeneca. In addition, we are developing a cancer drug pipeline that includes antibody-drug conjugates (ADCs), precision-targeted small molecules, and individualized neoantigen therapies (INT)."
We are focusing on cancer drug development in three main directions. First, expanding treatments for new cancer types with limited treatment options; second, expanding into early-stage cancer treatments that are expected to yield better results than existing therapies; and third, developing combination therapies and integrated formulations to enhance treatment response. For example, combining the mRNA-based cancer vaccine 'mRNA-4157 (V940)' that is currently in clinical trials with Keytruda increases anti-cancer responses, and using the ADC 'sacituzumab govitecan' to enhance the immune response sensitivity of cancer cells. We are also developing innovative therapies such as MK-1084, an oral selective inhibitor targeting the KRAS G12C mutation commonly found in non-small cell lung cancer.
How many cancer drugs has MSD commercialized so far?
"A total of five. Currently, we are developing several dozen cancer drug pipeline candidates, including MK-1022, MK-2870, and MK-5909, with 30 candidates in late-stage (Phase 3 or 2/3) clinical trials as of September 2024."
What is the secret behind MSD's leading position in new drug development?
"The key is our commitment to concentrating personnel and resources on research and development (R&D) under the mission of 'saving lives and improving the quality of life for people around the world.' As of 2023, about 30% (approximately 23,500) of our employees (about 75,000) are involved in research. As of February 2025, approximately 28% (145 people) of employees at Korea MSD are involved in R&D. We invested over $30.5 billion in R&D, which accounted for more than half of our annual revenue ($60.1 billion) in 2023, and approximately 28% of our revenue ($64.2 billion) in 2024 will be invested in R&D. In the case of Korea MSD, we invested approximately 70.3 billion won in R&D, including clinical research, as of 2023."
What types of cancer drugs are likely to lead the global cancer drug market in the future?
"We are very optimistic about ADCs. While traditional chemotherapy is a core therapeutic approach in several cancer types, ADCs precisely deliver cytotoxic drugs to tumor cells. By evaluating multiple ADC targets, we are conducting research that meaningfully improves current standard treatments for hard-to-treat cancers.
To develop these innovative new drugs, pharmaceutical companies need to analyze the genetic codes of cancers in greater depth. ADCs target biomarkers present on specific cancer cell surfaces, and the attached drug is directly delivered to cancer cells to maximize therapeutic effect. Over the past few decades, advancements in genetics have greatly changed treatment approaches with cancer biomarkers. In the past, cancer was simply classified into types like 'breast cancer' or 'lung cancer,' but now medical professionals analyze each cancer based on more precise information. This allows for a much more accurate understanding of cancer and the provision of personalized treatments for each patient. In that sense, ADCs have great potential for further development in the future.
In addition to academic and technological advancements, what else is needed to develop and commercialize new cancer drugs?
"For innovative new drugs like Keytruda to emerge and be commercialized, continuous R&D investments are essential. The development of cancer drugs is a complex process that consumes significant time and resources. It can take years or even decades to go from basic research to the development of candidate substances, clinical trials, and commercialization. Therefore, governments, pharmaceutical companies, and research institutions must continuously invest in R&D to bear the huge expenses incurred in this process. Without R&D investment, it is challenging to develop innovative treatments or new drugs, and to achieve progress that can increase the treatment possibilities for cancer patients."
또한, 조직 및 종양 샘플에서 패턴을 식별하는 데 AI를 점점 더 많이 활용하고 있다. AI 기술을 이용해 임상시험을 더 빠르게 시작하고 완료할 수 있도록 하며, 생성 AI를 통해 주요 시험 프로토콜을 간소화하고 데이터 수집 및 품질 검토 같은 노동 집약적인 작업의 효율성을 높이고 있다. 우리는 AI가 더 빠르고 명확하게 그리고 확실하게 질병을 감지하고 치료 효과를 평가하는 데 도움을 줄 수 있다고 믿는다.”
학문과 기술 발전 외에도 항암 신약을 개발하고 상용화하는 데 무엇이 필요한가.
The term "expense" refers to the reduction in net assets caused by a transaction.