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Merck's headquarters in Rahway. -MERCK
Merck's headquarters in Rahway. -MERCK
FDA clears Merck’s Keytruda for expanded use
Jessica Perry//March 30, 2023
Merck‘s best-selling cancer immunotherapy treatment Keytruda was granted full approval by the U.S. Food and Drug Administration for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, the Rahway-based pharmaceutical company announced March 29.
The move is the first full approval for an immunotherapy based on a predictive biomarker, regardless of solid tumor type, Merck said in its announcement.
It converts the FDA’s approval from accelerated to regular, or full, based on results from the Phase 2 KEYNOTE-158, KEYNOTE-164 and KEYNOTE-051 trials including data in 504 adult and pediatric patients with more than 30 types of cancer, Merck said.
According to the National Cancer Institute, dMMR is most common in colorectal cancer, other types of gastrointestinal cancer and endometrial cancer, but it may also be found in cancers of the breast, prostate, bladder and thyroid. It describes cells that have mutations in certain genes that are involved in correcting mistakes when DNA is copied in a cell. MSI-h, meanwhile, describes cancer cells that have a high number of mutations within a short segment of DNA, or microsatellite. Testing that shows mutations in 30% or more of those repeated sequences are known as MSI-H.
“This approval reinforces the important role of KEYTRUDA in certain patients with MSI-Hor dMMR solid tumors facing a variety of cancers,” Dr. Luis Diaz Jr., head of the division of solid tumor oncology, Memorial Sloan Kettering Cancer Center, said in a statement. “These data also further underscore the need for biomarker testing to identify patients who may be eligible for this therapy.”
Dr. Scot Ebbinghaus, vice president, Global Clinical Development, Merck Research Laboratories called the milestone a reflection of Merck’s commitment to biomarker research and personalized treatment plans for patients.
“Today’s approval builds on the 2017 accelerated approval of KEYTRUDA as the first immunotherapy with a tumor agnostic indication and supports the role of KEYTRUDA as an effective immunotherapy option based on a pan-tumor predictive biomarker,” he stated.
Keytruda is not just a best seller for Merck. It’s also one of the world’s top products, according to sales. Based on 2021 figures, Fierce Pharma ranked it at No. 4 worldwide last May with $17.2 billion in sales.
This past February, Merck announced that figure grew 22% to $20.9 billion in 2022. For the fourth quarter, sales were up 19% to $5.5 billion for the period.
In its release of Q4 and 2022 financial results, Merck said Keytruda’s growth “reflects continued strong momentum from metastatic indications … and increased uptake across recent earlier-stage launches …”
Keytruda is an anti-programmed death receptor-1 (anti-PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. Merck said the therapy is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD- L1 and PD-L2, thereby activating T lymphocytes, which may affect both tumor cells and healthy cells.
It is indicated for the treatment of patients with cancers including: melanoma, non-small cell lung cancer, head and neck squamous cell cancer, classical Hodgkin lymphoma, gastric cancer, esophageal cancer, cervical cancer, endometrial carcinoma, triple-negative breast cancer, and others.
According to the drug maker, there are currently more than 1,600 trials studying the use of Keytruda across a range of cancers and treatment settings in an effort to understand its role across cancers and factors that may help to predict how likely a patient is to benefit from the treatment.
