![]() KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma. Selected KEYTRUDA ® (pembrolizumab) Indications in the U.S. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers. There are currently more than 1,300 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. Merck has the industry’s largest immuno-oncology clinical research program. KEYTRUDA 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. KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. In Europe alone, it is estimated there were nearly 500,000 new cases of colorectal cancer.Ībout KEYTRUDA ® (pembrolizumab) Injection, 100 mg It is estimated there were about 1,850,000 new cases of colorectal cancer globally in 2018. Colorectal cancer is the third most commonly diagnosed cancer and the second most common cause of cancer-related death worldwide. Colorectal cancer often begins with growths on the inner lining of the colon or rectum called polyps, which can change into cancer over time. It is estimated approximately 5-15% of colorectal cancer patients have tumors that score as either MSI-H or dMMR when testing is performed.Ĭolorectal cancer starts in the colon or the rectum, and these cancers are referred to as colon cancer or rectal cancer depending on where the cancer starts. This defect is also referred to as mismatch repair deficiency (dMMR). The cause of MSI may be a defect in the ability to repair mistakes made when DNA is copied in the cell. Microsatellite instability (or MSI) is defined by the National Cancer Institute as a change that occurs in the DNA of certain cells, such as tumor cells, in which the number of repeats of microsatellites (short, repeated sequences of DNA) is different from the number of repeats that was in the DNA when it was inherited. The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union, and a final decision is expected in the first quarter of 2021. “This positive EU CHMP opinion reinforces the potential of KEYTRUDA as a new option for patients with MSI-H/dMMR colorectal cancer and illustrates our ongoing commitment to pursuing biomarker research to help address the needs of patients who have few effective options.”ĭata from KEYNOTE-177 were presented at the virtual scientific program of the 2020 American Society of Clinical Oncology Annual Meeting and were published in The New England Journal of Medicine. ![]() Vicki Goodman, vice president, clinical research, Merck Research Laboratories. “Patients in Europe with MSI-H/dMMR colorectal cancer have had only chemotherapy-containing regimens available to them in the first-line treatment setting and have historically faced poor outcomes,” said Dr. This recommendation is based on results from the pivotal Phase 3 KEYNOTE-177 trial, in which KEYTRUDA, as a monotherapy, demonstrated a significant improvement in progression-free survival compared to chemotherapy (investigator’s choice: mFOLFOX6 with or without bevacizumab or cetuximab or FOLFIRI with or without bevacizumab or cetuximab), a current standard of care. KENILWORTH, N.J.-( BUSINESS WIRE)-Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of adult patients with metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. ![]()
0 Comments
Leave a Reply. |