Swiss pharmaceutical giant Roche recently announced that the company's oncology kit VENTANA PD-L1 (SP263) has been approved by the US Food and Drug Administration (FDA) as an auxiliary diagnostic tool for Patients with locally advanced or metastatic urothelial carcinoma (mUC) treated with AstraZeneca PD-L1 immunotherapy Imfinzi (durvalumab) are provided to provide information on the status of programmed cell death ligand-1 (PD-L1) expression in patients. . This kit assesses the expression of PD-L1 in tumors by staining and scoring tumor cells and immune cells in the tumor microenvironment.
Programmed Death Ligand-1 (PD-L1) is a protein that participates in the inhibition of the immune system and affects the body's immune system's ability to fight cancer. Understanding the expression status of PD-L1 in tumors can help identify patients who are most likely to benefit from immunotherapy. Urinary tract carcinoma (UC) is the most common type of bladder cancer, accounting for approximately 90% of all bladder cancer cases. In the United States, bladder cancer is the fifth most common type of cancer, and men are 3-4 times more likely to be ill. It is estimated that in 2017, approximately 79,000 people in the United States will be diagnosed with bladder cancer, and approximately 17,000 people will die of bladder cancer.
Ann Costello, head of Roche Tissue Diagnostics, said that urothelial carcinoma (UC) is a treatment area that is far from being met by medical needs. The company is very pleased that the FDA can approve the kit VENTANA PD-L1 (SP263). Assay, the kit will provide clinicians with a powerful tool to help doctors develop the most appropriate treatment for their patients.
Roche said it will continue to advance the regulatory review of the kit VENTANA PD-L1 (SP263) for use in other cancer indications in the United States and other geographic regions. The collaboration with AstraZeneca reinforces Roche's ongoing commitment to personalized healthcare through innovative diagnostic solutions.
AstraZeneca's Imfinzi is a PD-L1 immunotherapy, which was approved by the US FDA in early May for the treatment of advanced bladder cancer, specifically: (1) local late stage of progression of platinum-containing chemotherapy or after chemotherapy Or patients with metastatic urothelial carcinoma (mUC); (2) preoperative (neoadjuvant treatment) or postoperative (adjuvant treatment) receiving local advanced or metastatic disease progression within 12 months of platinum-containing chemotherapy Patients with urothelial carcinoma (mUC). In clinical trials, the objective response rate of Imfinzi in patients with high expression of tumor PD-L1 was 26.3%, while the objective response rate in patients with low or negative PD-L1 was only 4.1%. .
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