Pumitamig
BRISTOL MYERS SQUIBB CO BMY CELG-RI · Non-Small Cell Lung Cancer (NSCLC); Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma; Untreated, Unresectable, or Metastatic Colorectal Cancer
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Phase 3
Not recorded
Linked trials
4
From ClinicalTrials.gov
Latest FDA action
None on record
From Drugs@FDA
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- BRISTOL MYERS SQUIBB CO BMY CELG-RI Source: Company record for BRISTOL MYERS SQUIBB CO (opens in a new tab)
- Indications
- Non-Small Cell Lung Cancer (NSCLC); Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma; Untreated, Unresectable, or Metastatic Colorectal Cancer Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 CompletedFirst trial start 31 Dec 20252 linked trials
- Phase 3 Current stageFirst trial start 31 Dec 20254 linked trials
- Filed Not yet
- Approved Not yet
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Pumitamig. Editors add each one with its source.
Filed application
No filed application is on record for Pumitamig. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Pumitamig.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT07361497ClinicalTrials.gov record for NCT07361497 (opens in a new tab) | A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) (ROSETTA Lung-201) | Phase 3 | Recruiting | 850 (estimated) | 18 Sep 2030 (estimated) | No |
| NCT07221149ClinicalTrials.gov record for NCT07221149 (opens in a new tab) | A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (ROSETTA Gastric-204) | Phase 2/3 | Recruiting | 690 (estimated) | 8 Nov 2030 (estimated) | No |
| NCT07361510ClinicalTrials.gov record for NCT07361510 (opens in a new tab) | A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%. (ROSETTA Lung-202) | Phase 3 | Recruiting | 750 (estimated) | 14 Oct 2031 (estimated) | No |
| NCT07221357ClinicalTrials.gov record for NCT07221357 (opens in a new tab) | A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer | Phase 2/3 | Recruiting | 990 (estimated) | 2 Feb 2030 (estimated) | No |
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
No FDA approvals on record for this drug.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
EMA's medicines data lists no human medicine with the same active substance as Pumitamig.
Source: European Medicines Agency (EMA), medicines data download.
Related news
No recent headlines mention this drug.
Sources
- ClinicalTrials.gov NCT07361510 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT07221149 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT07361497 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT07221357 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.