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On June 15th, Merck (MSD) announced that its blockbuster PD-1 inhibitor pembrolizumab (trade name: Keytruda) has been approved by China National Medical Products Administration (NMPA) for single-drug use KRAS, NRAS and BRAF genes are the first-line treatment for patients with wild-type, unresectable or metastatic high microsatellite instability (MSI-H) or mismatch repair gene defect (dMMR) colorectal cancer (CRC)
On June 15th, Merck (MSD) announced that its blockbuster PD-1 inhibitor pembrolizumab (trade name: Keytruda) has been approved by China National Medical Products Administration (NMPA) for single-drug use KRAS, NRAS and BRAF genes are the first-line treatment for patients with wild-type, unresectable or metastatic high microsatellite instability (MSI-H) or mismatch repair gene defect (dMMR) colorectal cancer (CRC)
The KEYNOTE-177 study was elected as the LBA oral report at the 2020 American Society of Clinical Oncology (ASCO) annual meeting, and its results were also published in the New England Journal of Medicine (NEJM) at the end of 2020, becoming the field of colorectal cancer that year One of the most concerned clinical research results
It is worth mentioning that the FDA has approved pembrolizumab for the first-line treatment of patients with unresectable or metastatic MSI-H/dMMR colorectal cancer in June 2020
Advanced colon cancer is a common malignant tumor with high incidence in the world
Professor Shen Lin, deputy dean of Peking University Cancer Hospital, director of the Department of Digestive Oncology, and deputy director of the Beijing Institute of Cancer Prevention and Treatment, pointed out: “In clinical practice, MSI-H/dMMR is one of the prognostic indicators for the treatment of colorectal cancer.
According to the press release, this is also the seventh indication approved for pembrolizumab in China since its first indication in China in July 2018
It is suitable for the treatment of unresectable or metastatic melanoma that has failed first-line treatment;
Combination of pemetrexed and platinum-based chemotherapy is suitable for the first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) with negative epidermal growth factor receptor (EGFR) gene mutation and anaplastic lymphoma kinase (ALK) negative;
Applicable to the first-line monotherapy for locally advanced or metastatic non-small cell lung cancer with EGFR gene mutation negative and ALK negative with PD-L1 tumor proportion score (TPS) ≥ 1% approved by the NMPA;
Combining carboplatin and paclitaxel is suitable for the first-line treatment of patients with metastatic squamous non-small cell lung cancer;
A single agent is used to evaluate the treatment of patients with PD-L1 expression [comprehensive positive score (CPS) ≥10], previous first-line systemic treatment failure, locally advanced or metastatic esophageal squamous cell carcinoma through fully validated tests;
A single agent is used to evaluate the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma whose tumors express PD-L1 (CPS≥20) through fully validated tests;
It is used for the first-line treatment of patients with wild-type, unresectable or metastatic MSI-H or dMMR colorectal cancer with KRAS, NRAS and BRAF genes
Congratulations to Merck’s pembrolizumab for its approval in China for another new indication, and hope that this approval will bring new treatment options to patients with advanced colorectal cancer and benefit more patients