Programmed Death Ligand 1 (PD-L1) Qualitative Protein Assay - Vietnam Registration 2401200ĐKLH/BYT-HTTB

The VENTANA PD-L1 (SP263) Assay is used to qualitatively detect Programmed Death Ligand 1 (PD-L1) protein in formalin-fixed, paraffin-embedded lung cancer tissue specimens stained with the OptiView DAB IHC Detection Kit on the BenchMark IHC/ISH instrument. The expression of PD-L1 on tumor cells (TC) is detected by the VENTANA PD-L1 (SP263) Assay in NSCLC and is indicated to support patient selection for treatment with IMFINZI™ (durvalumab). The expression of PD-L1 on tumor cells (TC) is detected by the VENTANA PD-L1 (SP263) Assay in NSCLC and is indicated to support patient selection for treatment with KEYTRUDA® (pembrolizumab). The expression of PD-L1 on tumor cells (TC) is detected by the VENTANA PD-L1 (SP263) Assay in NSCLC and may be associated with improved survival benefit from OPDIVO® (nivolumab). The expression of PD-L1 on tumor cells (TC) is detected by the VENTANA PD-L1 (SP263) Assay in NSCLC and is indicated to support patient selection for treatment with TECENTRIQ® (atezolizumab). This product must be interpreted by a qualified pathologist in conjunction with histology testing, relevant clinical information, and appropriate biopsy specimens. This product is intended for in vitro diagnostic use (IVD). The test is intended to identify patients who may benefit from treatment with the therapies described in Table 1. Please consult the corresponding drug label for information on clinical recommendations appropriate for PD-L1 expression. Table 1. Cancer Types and Intended Use Intended Use: NSCLC Therapy and PD-L1 Expression - Preferred Treatment Sequence - IMFINZI™: ≥ 1% TC – After chemotherapy radiation therapy (CRT) - KEYTRUDA®: ≥ 50% TC – First-line therapy, ≥ 1% TC – Second-line therapy - OPDIVO®: ≥ 1%, ≥ 5% and ≥ 10% TC – Second-line therapy - TECENTRIQ®: ≥ 1% TC – Adjuvant therapy after resection and platinum-based chemotherapy.