Cosibelimab
Also known as Unloxcyt, Cosibelimab-ipdl
Checkpoint Therapeutics, Inc. · Metastatic Non-squamous Non Small Cell Lung Cancer
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
1
From ClinicalTrials.gov
Latest FDA action
Approved
BLA761297,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- Checkpoint Therapeutics, Inc. Source: Company record for Checkpoint Therapeutics, Inc. (opens in a new tab)
- Indication
- Metastatic Non-squamous Non Small Cell Lung Cancer Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Application
- BLA 761297 · Standard review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for BLA 761297 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 CompletedFirst trial start 8 Dec 20211 linked trial
- Filed Completed
- Approved Current stageFirst approval 13 Dec 2024
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 Cosibelimab. Editors add each one with its source.
Filed application
No filed application is on record for Cosibelimab. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Cosibelimab.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT04786964ClinicalTrials.gov record for NCT04786964 (opens in a new tab)CONTERNO | Study of Pemetrexed+Platinum Chemotherapy With or Without Cosibelimab in First Line Metastatic Non-squamous NSCLC | Phase 3 | Terminated | 25 (actual) | 30 Dec 2023 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT04786964 (opens in a new tab) |
Posted results on ClinicalTrials.gov for CONTERNO Serious adverse events (Adverse event monitoring was performed throughout the study; after the end of treatment, subjects were followed for a minimum of 30 days for AE monitoring and up to 90 days for SAEs and irAEs through study completion, up to 24 months. Note the study was prematurely terminated due to the geopolitical conflict in the region.): Cosibelimab 2 of 19; Control 1 of 6 Source: ClinicalTrials.gov results for NCT04786964 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. | ||||||
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
| Application | Action | Date | Outcome | Review | Source |
|---|---|---|---|---|---|
| BLA761297Action letter for BLA761297 (opens in a new tab) | Supplement 1 Efficacy | Approved | standard | Drugs@FDA via openFDA (opens in a new tab) | |
| BLA761297Action letter for BLA761297 (opens in a new tab) | Original 1 Type 1 - New Molecular Entity | Approved | standard | Drugs@FDA via openFDA (opens in a new tab) |
Data provided by the U.S. Food and Drug Administration.
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 Cosibelimab.
Source: European Medicines Agency (EMA), medicines data download.
Related news
Sources
- Drugs@FDA 761297 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT04786964 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA BLA761297 (opens in a new tab) Licence: cc0. Fetched
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.