Squamous cell carcinoma of the head and neck (SCCHN)
PD-L1 IHC 28-8 pharmDx for Autostainer Link 48
This is an in vitro diagnostic medical device that tests PD-L1 protein expression in non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, and esophageal carcinoma tissues (FFPE) using immunohistochemical assay.
Companion diagnosis
Non-small cell lung cancer
- Assist in identifying patients screeningwith NSCLC who will receive combination therapy of OPDIVO® (nivolumab) and YERVOY® (ipilimumab) according to the expression of PD-L1 (≥ 1% tumor cell expression)
Esophageal squamous cell carcinoma
- Assist in identifying patients with esophageal squamous cell carcinoma (ESCC) who will receive OPDIVO® (nivolumab) in combination with fluoropyrimidine- and platinum-based chemotherapy or combination therapy of OPDIVO® (nivolumab) and YERVOY® (ipilimumab) according to the expression of PD-L1 (≥ 1% tumor cell expression)
Complementary diagnosis
Non-squamous non-small cell lung cancer
- Assist in estimating enhanced survival according to tumor cell PD-L1 expression levels (≥ 1 % or ≥ 5 % or ≥ 10 %) when OPDIVO® (nivolumab) is prescribed for patients with non-squamous non-small cell lung cancer (nsNSCLC)
Squamous cell carcinoma of the head and neck
- Assist in estimating enhanced survival according to a tumor cell PD-L1 expression level (≥ 1 %) when OPDIVO® (nivolumab) is prescribed for patients with SCCHN
Gastric, GEJ, and esophageal adenocarcinoma
-Assist in estimating PD-L1 expression (CPS ≥ 5 in gastric, GEJ, or esophageal adenocarcinoma may relate with the progression-free survival and enhanced survival when combination therapy of OPDIVO® (nivolumab) and chemotherapy is used.