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On September 3, the State Food and Drug Administration announced that the eighth indication of Merck’s PD-1 inhibitor pembrolizumab injection (Keytruda, pembrolizumab, K for short) was approved in China.
It was soon applied to the first-line treatment of advanced esophageal cancer
.
Pembrolizumab is a blockbuster PD-1 inhibitor developed by Merck, which blocks the PD-1/PD-L1 signaling pathway and improves the anti-cancer response of human immune cells
.
Since the advent of this new tumor immunity drug, it has been approved globally for the treatment of multiple cancer types
In China, Pembrolizumab injection has been approved for 7 indications in China, namely:
It is suitable for the treatment of unresectable or metastatic melanoma that has failed first-line treatment;
Applicable to the locally advanced stage of epidermal growth factor receptor (EGFR) gene mutation negative and anaplastic lymphoma kinase (ALK) negative for PD-L1 tumor proportion score (TPS) ≥ 1% approved by the National Medical Products Administration Or first-line monotherapy for metastatic non-small cell lung cancer (NSCLC);
Combination of pemetrexed and platinum-based chemotherapy is suitable for the first-line treatment of metastatic non-squamous non-small cell lung cancer with negative EGFR gene mutation and ALK negative;
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), previously failed first-line systemic therapy, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) through a fully validated test ;
A single agent is used to evaluate the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (CPS≥20) through fully validated tests;
And single agent for KRAS, NRAS and BRAF genes are wild-type, unresectable or metastatic high microsatellite instability (MSI-H) or mismatch repair gene defect (dMMR) colorectal cancer (CRC) patients First-line treatment