FDA Oncology Announcements

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13 Announcements

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 tremelimumab in combination with durvalumab and platinum-based chemotherapy for metastatic non-small cell lung cancer

Trial: POSEIDON
Drugs: Imjudo (tremelimumab) · Anti-CTLA-4 antibody, Imfinzi (durvalumab) · Anti-PD-L1 antibody
Condition: Thoracic

FDA approves tremelimumab in combination with durvalumab for unresectable hepatocellular carcinoma

Trial: HIMALAYA
Drugs: Imjudo (tremelimumab) · Anti-CTLA-4 antibody, durvalumab · Anti-PD-L1 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 approves nivolumab and ipilimumab for unresectable malignant pleural mesothelioma

Trial: CheckMate743
Drugs: OPDIVO (nivolumab) · Anti-PD-1 antibody, YERVOY (ipilimumab) · Anti-CTLA-4 antibody
Conditions: Other solid neoplasmThoracic

FDA approves nivolumab plus ipilimumab and chemotherapy for first-line treatment of metastatic NSCLC

Trial: CheckMate 9LA
Drugs: OPDIVO (nivolumab) · Anti-PD-1 antibody, YERVOY (ipilimumab) · Anti-CTLA-4 antibody
Condition: Thoracic

FDA approves nivolumab plus ipilimumab for first-line mNSCLC (PD-L1 tumor expression ≥1%)

Trial: CheckMate 227
Drugs: OPDIVO (nivolumab) · Anti-PD-1 antibody, YERVOY (ipilimumab) · Anti-CTLA-4 antibody
Condition: Thoracic

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 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 approves nivolumab plus ipilimumab combination for intermediate or poor-risk advanced renal cell carcinoma

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

Nivolumab in combination with ipilimumab

Drugs: Opdivo (nivolumab) · Anti-PD-1 antibody, ipilimumab · Anti-CTLA-4 antibody

Ipilimumab

Drug: YERVOY (ipilimumab) · Anti-CTLA-4 antibody