Neoplasm.News

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61 Announcements

2026-05-08

FDA approves zenocutuzumab-zbco for advanced, unresectable or metastatic cholangiocarcinoma

Drug: Bizengri (zenocutuzumab-zbco) · Anti-HER2-HER3 bispecific antibody
Condition: Gastrointestinal

2026-02-24

FDA grants traditional approval to encorafenib for metastatic colorectal cancer with a BRAF V600E mutation

Drugs: Braftovi (encorafenib) · BRAF inhibitor, cetuximab · Anti-EGFR antibody
Condition: Gastrointestinal

2025-11-25

FDA approves durvalumab for resectable gastric or gastroesophageal junction adenocarcinoma

Drugs: Imfinzi (durvalumab) · Anti-PD-L1 antibody, fluorouracil · Fluoropyrimidine
Condition: Gastrointestinal

2025-05-15

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

2025-04-11

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

2025-04-08

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

2025-03-26

FDA approves cabozantinib for adults and pediatric patients 12 years of age and older with pNET and epNET

Drug: Cabometyx (cabozantinib) · VEGFR inhibitor
Conditions: EndocrineGastrointestinal

2025-03-19

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

2025-01-16

FDA approves sotorasib with panitumumab for KRAS G12C-mutated colorectal cancer

Trial: CodeBreak300
Drugs: Lumakras (sotorasib) · KRAS inhibitor, Vectibix (panitumumab) · Anti-EGFR antibody
Condition: Gastrointestinal

2024-12-20

FDA grants accelerated approval to encorafenib with cetuximab and mFOLFOX6 for metastatic colorectal cancer with a BRAF V600E mutation

Drugs: Braftovi (encorafenib) · BRAF inhibitor, cetuximab · Anti-EGFR antibody
Condition: Gastrointestinal

2024-12-04

FDA grants accelerated approval to zenocutuzumab-zbco for non-small cell lung cancer and pancreatic adenocarcinoma

Drug: Bizengri (zenocutuzumab-zbco) · Anti-HER2-HER3 bispecific antibody
Conditions: GastrointestinalThoracic

2024-11-21

FDA grants accelerated approval to zanidatamab-hrii for previously treated unresectable or metastatic HER2-positive biliary tract cancer

Trial: HERIZON-BTC-01
Drug: Ziihera (zanidatamab-hrii) · Anti-HER2 bispecific antibody
Condition: Gastrointestinal

2024-10-18

FDA approves zolbetuximab-clzb with chemotherapy for gastric or gastroesophageal junction adenocarcinoma

Trials: Spotlight, GLOW
Drug: Vyloy (zolbetuximab-clzb) · Anti-CLDN18.2 antibody
Condition: Gastrointestinal

2024-06-21

FDA grants accelerated approval to adagrasib with cetuximab for KRAS G12C-mutated colorectal cancer

Drugs: Krazati (adagrasib) · KRAS inhibitor, cetuximab · Anti-EGFR antibody
Condition: Gastrointestinal

2024-06-13

FDA grants accelerated approval to repotrectinib for adult and pediatric patients with NTRK gene fusion-positive solid tumors

Trial: TRIDENT-1
Drug: AUGTYRO (repotrectinib) · ROS1 inhibitor
Condition: Other solid neoplasm

2024-05-16

FDA grants accelerated approval to infigratinib for metastatic cholangiocarcinoma

Condition: Gastrointestinal

2024-04-05

FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2-positive solid tumors

Trials: DPT02, DESTINY-Lung01, DESTINY-CRC02
Drug: Enhertu (fam-trastuzumab deruxtecan-nxki) · Anti-HER2 antibody-drug conjugate
Condition: Other solid neoplasm

2024-02-13

FDA approves irinotecan liposome for first-line treatment of metastatic pancreatic adenocarcinoma

Trial: NAPOLI 3
Drugs: Onivyde (irinotecan liposome) · Topoisomerase I inhibitor, oxaliplatin · Platinum agent
Condition: Gastrointestinal

2023-11-16

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

2023-11-08

FDA approves fruquintinib in refractory metastatic colorectal cancer

Trials: FRESCO-2, FRESCO
Drug: Fruzaqla (fruquintinib) · VEGFR inhibitor
Condition: Gastrointestinal

2023-11-07

FDA amends pembrolizumab’s gastric cancer indication

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

2023-10-31

FDA approves pembrolizumab with chemotherapy for biliary tract cancer

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

2023-08-02

FDA approves trifluridine and tipiracil with bevacizumab for previously treated metastatic colorectal cancer

Trial: SUNLIGHT
Drugs: LONSURF (trifluridine and tipiracil) · Fluoropyrimidine, bevacizumab · Anti-VEGFR antibody
Condition: Gastrointestinal

2023-01-19

FDA grants accelerated approval to tucatinib with trastuzumab for colorectal cancer

Drugs: Tukysa (tucatinib) · ERBB2 inhibitor, trastuzumab · Anti-HER2 antibody
Condition: Gastrointestinal

2022-10-21

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

2022-09-30

FDA grants accelerated approval to futibatinib for cholangiocarcinoma

Drug: Lytgobi (futibatinib) · FGFR inhibitor
Condition: Gastrointestinal

2022-09-21

FDA approves selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors

Trial: LIBRETTO-001
Drug: Retevmo (selpercatinib) · RET inhibitor
Condition: Other solid neoplasm

2022-09-20

FDA approves sodium thiosulfate to reduce the risk of ototoxicity associated with cisplatin in pediatric patients with localized, non-metastatic solid tumors

Trial: SIOPEL6
Condition: Other solid neoplasm

2022-09-02

FDA approves durvalumab for locally advanced or metastatic biliary tract cancer

Trial: TOPAZ-1
Drugs: Imfinzi (durvalumab) · Anti-PD-L1 antibody, gemcitabine · Pyrimidine analog, cisplatin · Platinum agent
Condition: Gastrointestinal

2022-06-22

FDA grants accelerated approval to dabrafenib in combination with trametinib for unresectable or metastatic solid tumors with BRAF V600E mutation

Drugs: Tafinlar (dabrafenib) · BRAF inhibitor, Mekinist (trametinib) · MEK inhibitor, trametinib is not indicated · MEK inhibitor
Condition: Other solid neoplasm

2022-05-27

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

Trial: CheckMate 648
Condition: Gastrointestinal

2021-08-25

FDA approves ivosidenib for advanced or metastatic cholangiocarcinoma

Trial: ClarIDHy
Drug: Tibsovo (ivosidenib) · IDH inhibitor
Condition: Gastrointestinal

2021-08-17

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

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

2021-05-20

FDA approves nivolumab for resected esophageal or GEJ cancer

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

2021-05-05

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

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

2021-04-16

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

2021-03-22

FDA approves pembrolizumab for esophageal or GEJ carcinoma

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

2021-01-15

FDA approves fam-trastuzumab deruxtecan-nxki for HER2-positive gastric adenocarcinomas

Drug: Enhertu (fam-trastuzumab deruxtecan-nxki) · Anti-HER2 antibody-drug conjugate
Condition: Gastrointestinal

2020-10-26

FDA Approves Companion Diagnostic to identify NTRK fusions in solid tumors for Vitrakvi

Trials: SCOUT, NAVIGATE
Condition: Other solid neoplasm

2020-06-29

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

2020-06-16

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

2020-06-10

FDA approves nivolumab for esophageal squamous cell carcinoma

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

2020-05-29

FDA approves atezolizumab plus bevacizumab for unresectable hepatocellular carcinoma

Trial: IMbrave150
Drugs: TECENTRIQ (atezolizumab) · Anti-PD-L1 antibody, AVASTIN (bevacizumab) · Anti-VEGFR antibody
Condition: Gastrointestinal

2020-04-20

FDA grants accelerated approval to pemigatinib for cholangiocarcinoma with an FGFR2 rearrangement or fusion

Drug: PEMAZYRE (pemigatinib) · FGFR inhibitor
Condition: Gastrointestinal

2020-04-08

FDA approves encorafenib in combination with cetuximab for metastatic colorectal cancer with a BRAF V600E mutation

Trial: BEACON CRC
Drugs: BRAFTOVI (encorafenib) · BRAF inhibitor, cetuximab · Anti-EGFR antibody
Condition: Gastrointestinal

2020-03-10

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

2019-12-27

FDA approves olaparib for gBRCAm metastatic pancreatic adenocarcinoma

Trial: POLO
Drug: LYNPARZA (olaparib) · PARP inhibitor
Condition: Gastrointestinal

2019-07-30

FDA approves pembrolizumab for advanced esophageal squamous cell cancer

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

2019-05-10

FDA approves ramucirumab for hepatocellular carcinoma

Trial: REACH-2
Drug: CYRAMZA (ramucirumab) · Anti-VEGFR antibody
Condition: Gastrointestinal

2019-02-22

FDA approves Lonsurf for recurrent, metastatic gastric and gastroesophageal junction adenocarcinoma

Drug: LONSURF (trifluridine/ tipiracil) · Fluoropyrimidine
Condition: Gastrointestinal

2019-01-14

FDA approves cabozantinib for hepatocellular carcinoma

Trial: CELESTIAL
Drug: CABOMETYX (cabozantinib) · VEGFR inhibitor
Condition: Gastrointestinal

2018-11-26

FDA approves larotrectinib for solid tumors with NTRK gene fusions

Trials: SCOUT, NAVIGATE
Drug: VITRAKVI (larotrectinib) · TRK inhibitor
Condition: Other solid neoplasm

2018-11-09

FDA grants accelerated approval to pembrolizumab for hepatocellular carcinoma

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

2018-08-16

FDA approves lenvatinib for unresectable hepatocellular carcinoma

Drug: Lenvima (lenvatinib) · Multikinase inhibitor
Condition: Gastrointestinal

2018-07-10

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

2017-09-22

FDA grants accelerated approval to pembrolizumab for advanced gastric cancer

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

2017-09-22

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

Trial: CheckMate040
Drug: OPDIVO (nivolumab) · Anti-PD-1 antibody
Condition: Gastrointestinal

2017-08-01

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

Trial: CheckMate142
Drug: OPDIVO (nivolumab) · Anti-PD-1 antibody
Conditions: GastrointestinalOther solid neoplasm

2015-04-24

Ramucirumab mCRC

Condition: Gastrointestinal

2006-09-27

FDA approves Vectibix (panitumumab) to treat metastatic colorectal carcinoma

Drug: Vectibix (panitumumab) · Anti-EGFR antibody
Condition: Gastrointestinal

2006-06-20

FDA approves a labeling extension for bevacizumab (Avastin, Genentech) for second-line treatment of metastatic carcinoma of the colon or rectum

Condition: Gastrointestinal

FDA approves zenocutuzumab-zbco for advanced, unresectable or metastatic cholangiocarcinoma

FDA grants traditional approval to encorafenib for metastatic colorectal cancer with a BRAF V600E mutation

FDA approves durvalumab for resectable gastric or gastroesophageal junction adenocarcinoma

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

FDA approves nivolumab with ipilimumab for unresectable or metastatic hepatocellular carcinoma

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

FDA approves cabozantinib for adults and pediatric patients 12 years of age and older with pNET and epNET

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

FDA approves sotorasib with panitumumab for KRAS G12C-mutated colorectal cancer

FDA grants accelerated approval to encorafenib with cetuximab and mFOLFOX6 for metastatic colorectal cancer with a BRAF V600E mutation

FDA grants accelerated approval to zenocutuzumab-zbco for non-small cell lung cancer and pancreatic adenocarcinoma

FDA grants accelerated approval to zanidatamab-hrii for previously treated unresectable or metastatic HER2-positive biliary tract cancer

FDA approves zolbetuximab-clzb with chemotherapy for gastric or gastroesophageal junction adenocarcinoma

FDA grants accelerated approval to adagrasib with cetuximab for KRAS G12C-mutated colorectal cancer

FDA grants accelerated approval to repotrectinib for adult and pediatric patients with NTRK gene fusion-positive solid tumors

FDA grants accelerated approval to infigratinib for metastatic cholangiocarcinoma

FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2-positive solid tumors

FDA approves irinotecan liposome for first-line treatment of metastatic pancreatic adenocarcinoma

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

FDA approves fruquintinib in refractory metastatic colorectal cancer

FDA amends pembrolizumab’s gastric cancer indication

FDA approves pembrolizumab with chemotherapy for biliary tract cancer

FDA approves trifluridine and tipiracil with bevacizumab for previously treated metastatic colorectal cancer

FDA grants accelerated approval to tucatinib with trastuzumab for colorectal cancer

FDA approves tremelimumab in combination with durvalumab for unresectable hepatocellular carcinoma

FDA grants accelerated approval to futibatinib for cholangiocarcinoma

FDA approves selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors

FDA approves sodium thiosulfate to reduce the risk of ototoxicity associated with cisplatin in pediatric patients with localized, non-metastatic solid tumors

FDA approves durvalumab for locally advanced or metastatic biliary tract cancer

FDA grants accelerated approval to dabrafenib in combination with trametinib for unresectable or metastatic solid tumors with BRAF V600E mutation

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

FDA approves ivosidenib for advanced or metastatic cholangiocarcinoma

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

FDA approves nivolumab for resected esophageal or GEJ cancer

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

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

FDA approves pembrolizumab for esophageal or GEJ carcinoma

FDA approves fam-trastuzumab deruxtecan-nxki for HER2-positive gastric adenocarcinomas

FDA Approves Companion Diagnostic to identify NTRK fusions in solid tumors for Vitrakvi

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

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

FDA approves nivolumab for esophageal squamous cell carcinoma

FDA approves atezolizumab plus bevacizumab for unresectable hepatocellular carcinoma

FDA grants accelerated approval to pemigatinib for cholangiocarcinoma with an FGFR2 rearrangement or fusion

FDA approves encorafenib in combination with cetuximab for metastatic colorectal cancer with a BRAF V600E mutation

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

FDA approves olaparib for gBRCAm metastatic pancreatic adenocarcinoma

FDA approves pembrolizumab for advanced esophageal squamous cell cancer

FDA approves ramucirumab for hepatocellular carcinoma

FDA approves Lonsurf for recurrent, metastatic gastric and gastroesophageal junction adenocarcinoma

FDA approves cabozantinib for hepatocellular carcinoma

FDA approves larotrectinib for solid tumors with NTRK gene fusions

FDA grants accelerated approval to pembrolizumab for hepatocellular carcinoma

FDA approves lenvatinib for unresectable hepatocellular carcinoma

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

FDA grants accelerated approval to pembrolizumab for advanced gastric cancer

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

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

Ramucirumab mCRC

FDA approves Vectibix (panitumumab) to treat metastatic colorectal carcinoma

FDA approves a labeling extension for bevacizumab (Avastin, Genentech) for second-line treatment of metastatic carcinoma of the colon or rectum

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