FDA Oncology Announcements

Anti-PD-1 × Gastrointestinal × Clear all

23 Announcements

FDA approves retifanlimab-dlwr with carboplatin and paclitaxel and as a single agent for squamous cell carcinoma of the anal canal

Drugs: Zynyz (retifanlimab-dlwr) · Anti-PD-1 antibody, carboplatin · Platinum agent, paclitaxel · Taxane
Condition: Gastrointestinal

FDA approves nivolumab with ipilimumab for unresectable or metastatic hepatocellular carcinoma

Trial: CheckMate 9DW
Drugs: Opdivo (nivolumab) · Anti-PD-1 antibody, Yervoy (ipilimumab) · Anti-CTLA-4 antibody
Condition: Gastrointestinal

FDA approves nivolumab with ipilimumab for unresectable or metastatic MSI-H or dMMR colorectal cancer

Trial: CheckMate 8HW
Drugs: Opdivo (nivolumab) · Anti-PD-1 antibody, Yervoy (ipilimumab) · Anti-CTLA-4 antibody
Conditions: GastrointestinalOther solid neoplasm

FDA approves pembrolizumab for HER2 positive gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)

Trial: MK-3475-811
Drugs: Keytruda (pembrolizumab) · Anti-PD-1 antibody, trastuzumab · Anti-HER2 antibody
Condition: Gastrointestinal

FDA approves pembrolizumab with chemotherapy for HER2-negative gastric or gastroesophageal junction adenocarcinoma

Trial: KEYNOTE-859
Drug: Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Gastrointestinal

FDA amends pembrolizumab’s gastric cancer indication

Drugs: Keytruda (pembrolizumab) · Anti-PD-1 antibody, trastuzumab · Anti-HER2 antibody
Condition: Gastrointestinal

FDA approves pembrolizumab with chemotherapy for biliary tract cancer

Trial: KEYNOTE-966
Drug: Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Gastrointestinal

FDA approves Opdivo in combination with chemotherapy and Opdivo in combination with Yervoy for first-line esophageal squamous cell carcinoma indications

Trial: CheckMate 648
Drugs: Opdivo (nivolumab) · Anti-PD-1 antibody, Yervoy (ipilimumab) · Anti-CTLA-4 antibody
Condition: Gastrointestinal

FDA grants accelerated approval to dostarlimab-gxly for dMMR advanced solid tumors

Drug: Jemperli (dostarlimab-gxly) · Anti-PD-1 antibody
Condition: Other solid neoplasm

FDA approves nivolumab for resected esophageal or GEJ cancer

Trial: CheckMate 577
Drug: Opdivo (nivolumab) · Anti-PD-1 antibody
Condition: Gastrointestinal

FDA grants accelerated approval to pembrolizumab for HER2-positive gastric cancer

Drugs: Keytruda (pembrolizumab) · Anti-PD-1 antibody, trastuzumab · Anti-HER2 antibody
Condition: Gastrointestinal

FDA approves nivolumab in combination with chemotherapy for metastatic gastric cancer and esophageal adenocarcinoma

Trial: CheckMate649
Drug: Opdivo (nivolumab) · Anti-PD-1 antibody
Condition: Gastrointestinal

FDA approves pembrolizumab for esophageal or GEJ carcinoma

Trial: KEYNOTE-590
Drug: Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Gastrointestinal

FDA approves pembrolizumab for first-line treatment of MSI-H/dMMR colorectal cancer

Trial: KEYNOTE-177
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Conditions: GastrointestinalOther solid neoplasm

FDA approves pembrolizumab for adults and children with TMB-H solid tumors

Trial: KEYNOTE 158
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Other solid neoplasm

FDA approves nivolumab for esophageal squamous cell carcinoma

Drug: OPDIVO (nivolumab) · Anti-PD-1 antibody
Condition: Gastrointestinal

FDA grants accelerated approval to nivolumab and ipilimumab combination for hepatocellular carcinoma

Trial: CheckMate040
Drugs: OPDIVO (nivolumab) · Anti-PD-1 antibody, YERVOY (ipilimumab) · Anti-CTLA-4 antibody
Condition: Gastrointestinal

FDA approves pembrolizumab for advanced esophageal squamous cell cancer

Trials: KEYNOTE-181, KEYNOTE-180
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Gastrointestinal

FDA grants accelerated approval to pembrolizumab for hepatocellular carcinoma

Trial: KEYNOTE-224
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Gastrointestinal

FDA grants accelerated approval to ipilimumab for MSI-H or dMMR metastatic colorectal cancer

Trial: CheckMate142
Drugs: YERVOY (ipilimumab) · Anti-CTLA-4 antibody, nivolumab · Anti-PD-1 antibody
Conditions: GastrointestinalOther solid neoplasm

FDA grants accelerated approval to nivolumab for HCC previously treated with sorafenib

Drug: OPDIVO (nivolumab) · Anti-PD-1 antibody
Condition: Gastrointestinal

FDA grants accelerated approval to pembrolizumab for advanced gastric cancer

Trial: KEYNOTE-059
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Gastrointestinal

FDA grants nivolumab accelerated approval for MSI-H or dMMR colorectal cancer

Drug: OPDIVO (nivolumab) · Anti-PD-1 antibody
Conditions: GastrointestinalOther solid neoplasm