Drugs / Ramucirumab
Regulatory milestones approvals, filings & regulatory actions · 17 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed gastroesophageal adenocarcinoma 3 milestones | |||||
| Filed | Japan (PMDA) | Cyramza | gastroesophageal adenocarcinoma | 2014-10-23 | “The company has also submitted Cyramza for the treatment of second line gastric cancer in Japan and was granted priority review.” lilly.com ↗ |
| Filed | US (FDA) | — | gastroesophageal adenocarcinoma | 2013-10-03 | “U.S. and EU regulatory submissions completed for ramucirumab as a single-agent treatment for patients with advanced gastric cancer” lilly.com ↗ “The U.S. rolling submission was completed for ramucirumab as a single-agent treatment for patients with advanced gastric cancer” lilly.com ↗ |
| Filed | EU (EMA) | — | gastroesophageal adenocarcinoma | 2013-10-03 | “U.S. and EU regulatory submissions completed for ramucirumab as a single-agent treatment for patients with advanced gastric cancer” lilly.com ↗ “A submission for ramucirumab for the same indication was also made in Europe.” lilly.com ↗ |
| Filed hepatocellular carcinoma 4 milestones | |||||
| Filed | US (FDA) | CYRAMZA | hepatocellular carcinoma | — | “Lilly has made regulatory submissions in the U.S., EU and Japan for the use of CYRAMZA in second-line treatment of patients with hepatocellular carcinoma.” lilly.com ↗ |
| Filed | Japan (PMDA) | CYRAMZA | hepatocellular carcinoma | — | “Lilly has made regulatory submissions in the U.S., EU and Japan for the use of CYRAMZA in second-line treatment of patients with hepatocellular carcinoma.” lilly.com ↗ |
| Filed | China (NMPA) | Cyramza | hepatocellular carcinoma | — | “for Cyramza® (ramucirumab) as second-line treatment in patients with HCC with baseline alpha-fetoprotein (AFP) ≥400ng/mL following first-line sorafenib was accepted by NMPA in...” innoventbio.com ↗ |
| Filed | EU (EMA) | CYRAMZA | hepatocellular carcinoma | — | “Lilly has made regulatory submissions in the U.S., EU and Japan for the use of CYRAMZA in second-line treatment of patients with hepatocellular carcinoma.” lilly.com ↗ |
| Filed non-small cell lung carcinoma 2 milestones | |||||
| Filed | US (FDA) | Cyramza | non-small cell lung carcinoma | 2014-10-23 | “Last year, Lilly made a U.S. regulatory submission based on the RELAY intent-to-treat (ITT) patient population” lilly.com ↗ “The company submitted Cyramza to the FDA as a treatment for second-line non-small cell lung cancer.” lilly.com ↗ |
| Filed | Japan (PMDA) | CYRAMZA | non-small cell lung carcinoma | — | “Lilly has made a submission in Japan with regulatory action expected by the end of 2020.” lilly.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (6) | US (FDA) | CYRAMZA | — | 2014-11-05 – 2025-04-07 | fda.gov ↗ |
| Approved | EU (EMA) | Cyramza | — | 2014-12-19 | europa.eu ↗ |
| Approved | US (FDA) | CYRAMZA | — | 2014-04-21 | fda.gov ↗ |
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News releases announcing trial results or a regulatory action · 39
| Date | Issuer | Release |
|---|---|---|
| 2026-09-18 | HanchorBio Inc. | Results HanchorBio to Present Five Clinical Abstracts at CSCO 2026 hanchorbio.com ↗
Among 15 efficacy-evaluable patients, the overall objective response rate (ORR) was 60%, highlighted by an 80% ORR in the 5.12–8 mg/kg mid-dose cohorts with a maximum tumor reduction of −78.2%. |
| 2026-06-30 | HanchorBio Inc. | Results HanchorBio Showcases HCB101 Myeloid-Enhancer Strategy in Gastric Cancer and HNSCC at JCA-AACR 2026 hanchorbio.com ↗
Across 15 efficacy-evaluable patients, dose-related antitumor activity was observed, including an 80% objective response rate in the mid-dose cohorts and a disease control rate of 93.3% across the overall cohort. |
| 2026-06-10 | HanchorBio Inc. | Results HanchorBio Presents Late-Breaking Data at FOCIS 2026 Supporting Innate-Immune Product Engine Across Oncology and Autoimmune Disease hanchorbio.com ↗
HCB101 combined with ramucirumab and paclitaxel achieved an overall objective response rate (ORR) of 57.1% |
| 2026-03-05 | HanchorBio Inc. | Results HanchorBio Presents Dose-Dependent Tumor Responses and Deepening Tumor Shrinkage with HCB101 Triple Combination in Second-Line Gastric Cancer at the 11th Asia-Pacific Gastroesophageal Cancer Congress hanchorbio.com ↗
The poster highlights early findings supporting dose-dependent antitumor activity of HCB101 in combination with ramucirumab and paclitaxel in patients with advanced gastric adenocarcinoma who progressed after first-line therapy. |
| 2026-01-09 | HanchorBio Inc. | Results HanchorBio Reports High Objective Response Rate with HCB101 Combination in Second-Line Gastric Cancer Following ASCO-GI 2026 Poster Presentation hanchorbio.com ↗
HanchorBio, Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today reported updated clinical data from its ongoing Phase Ib/IIa study evaluating HCB101 in combination with ramucirumab and paclitaxel in patients with previously treated gastric cancer. |
| 2025-01-22 | Agenus Inc. | Results Agenus Presents Data at ASCO GI Demonstrating Impact of BOT/BAL in Colorectal Cancer Across Neoadjuvant and Advanced Disease agenusbio.com ↗
The novel approach demonstrated early signals of activity and tolerability in the second-line treatment setting |
| 2022-10-10 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory The China NMPA Approved CYRAMZA® (ramucirumab) for the Treatment in Patients with Hepatocellular Carcinoma innoventbio.com ↗
the National Medical Products Administration (NMPA) of China has approved the supplemental New Drug Application (sNDA) for CYRAMZA® (ramucirumab) |
| 2020-05-29 | Eli Lilly and Company | Regulatory Lilly's CYRAMZA® (ramucirumab) Receives FDA Approval as First-Line Treatment for Metastatic EGFR-Mutated Non-Small Cell Lung Cancer lilly.com ↗
With this approval, CYRAMZA has now received six FDA approvals to treat certain types of lung, liver, stomach and colorectal cancers. |
| 2020-02-26 | Eli Lilly and Company | Regulatory FDA Advisory Committee Votes in Favor of Lilly's CYRAMZA® (ramucirumab) as First-Line Treatment for Metastatic EGFR-Mutated Non-Small Cell Lung Cancer lilly.com ↗ |
| 2019-12-13 | Eli Lilly and Company | Regulatory CHMP Issues Positive Opinion to Expand CYRAMZA® (ramucirumab) Label to Include Results from RELAY Study in Patients with Metastatic EGFR-Mutated Non-Small Cell Lung Cancer lilly.com ↗
The Committee agreed that the label should include an indication for CYRAMZA in combination with erlotinib for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations. |
| 2019-10-07 | Eli Lilly and Company | Results Lilly's CYRAMZA® (ramucirumab) Phase 3 Data in First-Line EGFR-Mutated Non-Small Cell Lung Cancer Published in The Lancet Oncology lilly.com ↗
The CYRAMZA-erlotinib combination achieved a median PFS of 19.4 months, corresponding to a seven-month improvement over erlotinib alone. |
| 2019-05-13 | Eli Lilly and Company | Regulatory Lilly's CYRAMZA® (ramucirumab) Becomes First FDA-Approved Biomarker-Driven Therapy in Patients with Hepatocellular Carcinoma lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has approved CYRAMZA® (ramucirumab injection, 10 mg/mL solution), as a single agent, for the treatment of patients with hepatocellular carcinoma (HCC) who have an alpha-fetoprotein (AFP) of ≥400 ng/mL and have been treated with sorafenib. |
| 2019-03-12 | Eli Lilly and Company | Results Lilly's CYRAMZA® (ramucirumab) Phase 3 RELAY Trial Met Primary Endpoint, Significantly Improving Progression-Free Survival in First-Line Treatment of Patients with Metastatic EGFR-Mutated Non-Small Cell Lung Cancer lilly.com ↗ |
| 2019-01-18 | Eli Lilly and Company | Results Lilly Phase 3 REACH-2 Trial Data Published in The Lancet Oncology Shows Improvement in Overall Survival with CYRAMZA® (ramucirumab) in Second-Line AFP-High Hepatocellular Carcinoma Patients lilly.com ↗
REACH-2 showed a statistically significant improvement in the primary endpoint of overall survival (OS) as well as in the secondary endpoint of progression-free survival (PFS). |
| 2018-04-24 | Eli Lilly and Company | Results Lilly Reports Strong First-Quarter 2018 Results, Raises EPS Guidance lilly.com ↗
The company announced additional results from a phase 3 study of Cyramza® (ramucirumab) in combination with docetaxel in patients with locally advanced or unresectable or metastatic urothelial carcinoma whose disease progressed on or after platinum-based chemotherapy. |
| 2018-04-20 | Eli Lilly and Company | Results Lilly Reports Additional Top-Line Results from CYRAMZA® (ramucirumab) Phase 3 RANGE Study in Advanced or Metastatic Urothelial Cancer lilly.com ↗
An improvement in objective response rate (ORR) was observed. |
| 2018-04-04 | Eli Lilly and Company | Results Lilly Announces CYRAMZA® (ramucirumab) Phase 3 REACH-2 Study in Second-Line Hepatocellular Carcinoma Patients Met Overall Survival Endpoint lilly.com ↗
The trial met its primary endpoint of overall survival (OS) as well as the secondary endpoint of progression-free survival (PFS). |
| 2017-12-08 | Eli Lilly and Company | Results Lilly Reports Top-Line Results from CYRAMZA® (ramucirumab) Phase 3 Study in First-Line Advanced Gastric Cancer lilly.com ↗
The trial met its primary endpoint of progression-free survival (PFS) but did not improve overall survival (OS), a secondary endpoint. |
| 2017-10-16 | Eli Lilly and Company | Results Rapidly Progressing Advanced Non-Small Cell Lung Cancer Patients Shown to Benefit in New CYRAMZA® (ramucirumab) Phase 3 Subgroup Analysis lilly.com ↗
This REVEL exploratory analysis demonstrated that efficacy, safety, and quality-of-life outcomes among patients receiving ramucirumab plus docetaxel who have aggressive disease with rapid progression on first-line therapy are consistent with the outcomes of the intent-to-treat population. |
| 2017-09-10 | Eli Lilly and Company | Results Lilly Builds Upon Body of Clinical Evidence for CYRAMZA® (ramucirumab) with Phase 3 RANGE Data Demonstrating Superior Progression-Free Survival in Advanced or Metastatic Urothelial Cancer lilly.com ↗
The data showed a statistically significant improvement in progression-free survival (PFS) in patients treated with ramucirumab plus docetaxel when compared to those who received placebo plus docetaxel, with a 46 percent prolongation in median PFS. |
| 2017-05-31 | Eli Lilly and Company | Results Lilly Announces Phase 3 RANGE Urothelial Cancer Trial of CYRAMZA® (ramucirumab) Met Primary Endpoint, Improving Progression-Free Survival lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced that its Phase 3 RANGE study of CYRAMZA® (ramucirumab) met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant improvement. |
| 2016-06-05 | Eli Lilly and Company | Results Early-Phase Immuno-Oncology Studies of Lilly's ALIMTA® (pemetrexed) and CYRAMZA® (ramucirumab) with Merck's KEYTRUDA® (pembrolizumab) Show Encouraging Results in Non-Small Cell Lung Cancer lilly.com ↗
In addition, cohort C patients achieved a disease control rate (DCR) of 85 percent, and 59 percent of patients reported stable disease. |
| 2015-09-28 | Eli Lilly and Company | Results Lilly's CYRAMZA® (ramucirumab) Significantly Improves Progression-Free Survival in Phase II Bladder Cancer Trial lilly.com ↗ |
| 2015-06-19 | Eli Lilly and Company | Results CYRAMZA® (ramucirumab) Hepatocellular Carcinoma Data Published by The Lancet Oncology lilly.com ↗
While the REACH trial's primary endpoint of overall survival favored the CYRAMZA arm, it was not statistically significant. |
| 2015-05-28 | Eli Lilly and Company | Results Lilly to Present CYRAMZA® (ramucirumab) Data at 2015 ASCO Annual Meeting lilly.com ↗
A Phase II, double-blind, multicenter trial in Japan of patients with advanced NSCLC who were treated in the second-line setting with either ramucirumab and docetaxel or placebo and docetaxel found that the ramucirumab arm had results consistent with those from the global Phase III REVEL trial, which supported the third U.S. approval for ramucirumab in 2014. |
| 2015-04-24 | Eli Lilly and Company | Regulatory Lilly's CYRAMZA® (ramucirumab) Receives Fourth FDA Approval lilly.com ↗
Eli Lilly and Company (NYSE: LLY) has received its fourth U.S. Food and Drug Administration (FDA) approval for CYRAMZA® (ramucirumab). |
| 2014-12-16 | Eli Lilly and Company | Regulatory Lilly's CYRAMZA® (ramucirumab) Receives Third FDA Approval lilly.com ↗
Specifically, CYRAMZA is now also indicated in combination with docetaxel, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy. |
| 2014-11-05 | Eli Lilly and Company | Regulatory Lilly's CYRAMZA® (ramucirumab) in Combination with Paclitaxel Granted FDA Approval for Advanced Gastric Cancer After Prior Chemotherapy lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved CYRAMZA® (ramucirumab) in combination with paclitaxel (a type of chemotherapy) as a treatment for people with advanced or metastatic gastric (stomach) or gastroesophageal junction (GEJ) adenocarcinoma whose cancer has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy. |
| 2014-09-18 | Eli Lilly and Company | Results CYRAMZA™ In Combination With Paclitaxel Significantly Improves Overall Survival In Second-Line Gastric Cancer Patients lilly.com ↗
In the trial, known as RAINBOW, the addition of ramucirumab to paclitaxel showed a statistically significant improvement in median overall survival, meeting its primary endpoint; it also met secondary endpoints of progression-free survival and objective response rate. |
| 2014-09-12 | Eli Lilly and Company | Results Lilly Announces CYRAMZA™ Phase III Second-Line Colorectal Cancer Trial Meets Primary Endpoint of Overall Survival lilly.com ↗
RAISE showed a statistically significant improvement in overall survival in patients treated with ramucirumab plus FOLFIRI compared to placebo plus FOLFIRI. |
| 2014-06-11 | Eli Lilly and Company | Results Lilly Announces Top-Line Results Of Phase III Hepatocellular Carcinoma Trial lilly.com ↗
Although the REACH study did not achieve statistical significance for survival, we are encouraged by the efficacy seen overall, especially in specific subpopulations. |
| 2014-06-02 | Eli Lilly and Company | Results Lilly's CYRAMZA™ (ramucirumab) Significantly Improves Overall Survival In Phase III Non-Small Cell Lung Cancer Study lilly.com ↗
REVEL is the first positive Phase III study of a biologic in combination with chemotherapy to demonstrate improved overall survival compared to chemotherapy alone in second-line NSCLC. |
| 2014-04-21 | Eli Lilly and Company | Regulatory Lilly's CYRAMZA™ (ramucirumab) Becomes First FDA-Approved Treatment for Advanced Gastric Cancer After Prior Chemotherapy lilly.com ↗
With this approval, CYRAMZA becomes the first FDA-approved treatment for patients in this setting. |
| 2014-02-19 | Eli Lilly and Company | Results Lilly Announces Ramucirumab Phase III Lung Cancer Trial Meets Primary Endpoint of Overall Survival lilly.com ↗
REVEL also showed a statistically significant improvement in progression-free survival in the ramucirumab arm compared to the control arm. |
| 2013-10-23 | Eli Lilly and Company | Regulatory FDA Grants Lilly's Ramucirumab Priority Review as a Potential Single-Agent Treatment for Advanced Gastric Cancer lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has assigned Priority Review to the regulatory submission for ramucirumab (IMC-1121B) as a single-agent treatment for advanced gastric cancer following disease progression after initial chemotherapy. |
| 2013-10-03 | Eli Lilly and Company | Results Single-Agent Ramucirumab Significantly Improves Overall Survival In Advanced Gastric Cancer Patients lilly.com ↗
Patients treated with single-agent ramucirumab (n=238) achieved a median overall survival of 5.2 months compared to 3.8 months for patients on the placebo arm (n=117), representing a 37 percent increase. |
| 2013-09-26 | Eli Lilly and Company | Results Lilly Announces Second Positive Ramucirumab Phase III Gastric Cancer Study Meets Primary Endpoint; Phase III Lilly/TRIO Breast Cancer Study Misses Primary Endpoint lilly.com ↗
The RAINBOW trial, a global Phase III study of ramucirumab in combination with paclitaxel in patients with advanced gastric cancer, met its primary endpoint of improved overall survival and a secondary endpoint of improved progression-free survival. |
| 2012-10-15 | Eli Lilly and Company | Results Lilly Announces Positive Results For Ramucirumab as Single Agent in Phase III Gastric Cancer Trial lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced that the REGARD trial, a Phase III study of ramucirumab (IMC-1121B) in patients with metastatic gastric cancer, met its primary endpoint of improved overall survival and also showed prolonged progression-free survival. |
| 2012-09-29 | Eli Lilly and Company | Results Lilly Releases Phase II Results for Monoclonal Antibody Ramucirumab in Lung Cancer lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced new data from two Phase II ramucirumab (IMC-1121B) trials in patients with non-small cell lung cancer (NSCLC). |
All press releases naming this drug 41 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 179 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ramucirumab | “Ramucirumab is a fully human immunoglobulin G1 monoclonal antibody receptor antagonist designed to block the ligand-binding site of vascular endothelial growth factor...” PMID 25787923 ↗ Mar 2015167“Immunotherapy, with agents including but not limited to ramucirumab, pembrolizumab, camrelizumab, and tislelizumab.” NCT07691645 ↗ “Biological/Vaccine Ramucirumab 947687-13-0” NCT05045404 ↗ “Drug: Ramucirumab” NCT03872947 ↗ |
| Known as | 1121B | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743062 ↗ |
| Known as | CYRAMZA | “healthy volunters receive Cyramza (Ramucirumab) 8mg/kg once” NCT03863587 ↗2“Ramucirumab 10 MG/ML Intravenous Solution [CYRAMZA]” NCT03686488 ↗ “Ramucirumab (CYRAMZA®)” NCT05071053 ↗ |
| Known as | IMC-1121B | “ramucirumab (IMC-1121B)” NCT01515306 ↗7“Ramucirumab (IMC-1121B)” NCT01427933 ↗ |
| Known as | LY3009806 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743062 ↗ |
| Known as | RAM | “Icrucumab (ICR) and ramucirumab (RAM) bind vascular endothelial growth factor (VEGF) receptors 1 and 2 (VEGFR-1 and -2), respectively.” PMID 28220020 ↗ Feb 20172“Ramucirumab (RAM) is a VEGFR2 monoclonal antibody.” PMID 37268519 ↗ Mar 2023 “ramucirumab (RAM)” NCT07546812 ↗ |
| Action | Inhibit | “Ramucirumab is a human immunoglobulin G1 antibody that binds vascular endothelial growth factor receptor-2 and blocks ligand-stimulated activation.” PMID 25185099 ↗ Sep 2014 |
| Modality | Monoclonal antibody | “a fully human monoclonal antibody targeting the vascular endothelial growth factor receptor-2” PMID 24930625 ↗ Jun 2014 |
| Route | Intravenous | “administered as an intravenous infusion” NCT00515697 ↗ |
| Target | KDR | “targeting the vascular endothelial growth factor receptor-2 in patients with advanced solid tumors.” PMID 25787923 ↗ Mar 2015 |