Cemiplimab
Also known as Libtayo, Cemiplimab-rwlc
REGENERON PHARMACEUTICALS, INC. REGN · Melanoma; Advanced Non-Small Cell Lung Cancer; Carcinoma，Non-Small-Cell Lung; Cutaneous Squamous Cell Carcinoma; Cutaneous Squamous Cell Carcinoma (CSCC)
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
9
From ClinicalTrials.gov
Latest FDA action
Approved
BLA761097,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- REGENERON PHARMACEUTICALS, INC. REGN Source: Company record for REGENERON PHARMACEUTICALS, INC. (opens in a new tab)
- Indications
- Melanoma; Advanced Non-Small Cell Lung Cancer; Carcinoma，Non-Small-Cell Lung; Cutaneous Squamous Cell Carcinoma; Cutaneous Squamous Cell Carcinoma (CSCC) Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Application
- BLA 761097 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for BLA 761097 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 CompletedFirst trial start 30 Jun 20232 linked trials
- Phase 3 CompletedFirst trial start 29 May 20179 linked trials
- Filed Completed
- Approved Current stageFirst approval 28 Sep 2018
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 Cemiplimab. Editors add each one with its source.
Filed application
No filed application is on record for Cemiplimab. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Cemiplimab.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT06585410ClinicalTrials.gov record for NCT06585410 (opens in a new tab) | Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma | Phase 3 | Recruiting | 369 (estimated) | 3 May 2030 (estimated) | No |
| NCT06246916ClinicalTrials.gov record for NCT06246916 (opens in a new tab) | A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head) | Phase 3 | Recruiting | 560 (estimated) | 22 Mar 2027 (estimated) | No |
| NCT05800015ClinicalTrials.gov record for NCT05800015 (opens in a new tab) | A Trial to Learn How the Combination of Fianlimab With Cemiplimab and Chemotherapy Works Compared With Cemiplimab and Chemotherapy for Treating Adult Patients With Advanced Non-small Cell Lung Cancer | Phase 2/3 | Active, not recruiting | 160 (actual) | 16 Jan 2030 (estimated) | No |
| NCT05785767ClinicalTrials.gov record for NCT05785767 (opens in a new tab) | A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) | Phase 2/3 | Active, not recruiting | 149 (actual) | 28 Sep 2027 (estimated) | No |
| NCT05608291ClinicalTrials.gov record for NCT05608291 (opens in a new tab) | A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery | Phase 3 | Active, not recruiting | 1,564 (actual) | 27 Jul 2026 (estimated) | No |
| NCT05352672ClinicalTrials.gov record for NCT05352672 (opens in a new tab) | Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma | Phase 3 | Active, not recruiting | 1,546 (actual) | 12 Mar 2026 (actual) | No |
Publications listing NCT05352672 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT03969004ClinicalTrials.gov record for NCT03969004 (opens in a new tab) | Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma | Phase 3 | Active, not recruiting | 415 (actual) | 7 Jan 2028 (estimated) | No |
Publications listing NCT03969004 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT03257267ClinicalTrials.gov record for NCT03257267 (opens in a new tab) | Study of Cemiplimab in Adults With Cervical Cancer | Phase 3 | Completed | 608 (actual) | 15 Mar 2021 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT03257267 (opens in a new tab) |
Posted results on ClinicalTrials.gov for NCT03257267
Serious adverse events (From first dose up to 90 following last dose (~42 months)): Cemiplimab 100 of 300; Chemotherapy* 84 of 290; Chemotherapy to Cemiplimab* 1 of 8 Source: ClinicalTrials.gov results for NCT03257267 (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. Publications listing NCT03257267 (2), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT03088540ClinicalTrials.gov record for NCT03088540 (opens in a new tab) | Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) | Phase 3 | Completed | 712 (actual) | 18 Apr 2025 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT03088540 (opens in a new tab) |
Posted results on ClinicalTrials.gov for NCT03088540
Serious adverse events (From signing of first informed consent up to 94 months.): Cemiplimab 131 of 356; Extended Treatment: Cemiplimab + Chemotherapy 23 of 85; Chemotherapy 103 of 343; Crossover: Chemotherapy to Cemiplimab 57 of 191 Source: ClinicalTrials.gov results for NCT03088540 (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. Publications listing NCT03088540 (6), newest first
All 6 publications for NCT03088540 Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
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
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)
Authorised
Libtayo (EMEA/H/C/004844)
- Authorised
- Therapeutic area
- Carcinoma, Squamous Cell
- Marketing authorisation holder
- Regeneron Ireland Designated Activity Company (DAC)
- Active substance (INN)
- cemiplimab
- ATC code
- L01XC33
- Latest EMA decision
Matched by active substance: EMA's INN or active substance equals this drug's name.
EMA page for Libtayo (opens in a new tab)EMA medicine data (opens in a new tab)
Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.
Related news
No recent headlines mention this drug.
Sources
- Drugs@FDA 761097 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT06585410 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT06246916 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05800015 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05785767 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05608291 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05352672 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT03969004 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT03257267 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT03088540 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA BLA761097 (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.