Drug · Monoclonal Antibody
Cemiplimab
CI-DRUG-00000735Explore in graph →CHEMBL4297723 Approved
Regulatory
Approvals (18)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
- Source
- Health Canada — Drug Product Database (DPD)
- Dataset
- Health Canada DPD
- Version
- dpd-2026-09-11
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- Open Government Licence – Canada (https://open.canada.ca/en/open-government-licence-canada)
- Run
- ING-HEALTHCANADADPD-20260911-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| CA Health Canada | — | Marketed in Canada as LIBTAYO (DIN 02487152) under ATC L01FF06 CEMIPLIMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Dec 8, 2023 | May 24, 2019 | health-canada-dpd |
| CA Health Canada | — | Marketed in Canada as LIBTAYO (DIN 02487144) under ATC L01FF06 CEMIPLIMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | May 24, 2019 | health-canada-dpd |
| EU EMA | — | Cutaneous Squamous Cell Carcinoma Libtayo as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC) who are not candidates for curative surgery or curative radiation. Libtayo as monotherapy is indicated for the adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation (see section 5.1 for selection criteria). Basal Cell Carcinoma Libtayo as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (laBCC or mBCC) who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI). Non-Small Cell Lung Cancer Libtayo as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 (in ? 50% tumour cells), with no EGFR, ALK or ROS1 aberrations, who have: locally advanced NSCLC who are not candidates for definitive chemoradiation, or metastatic NSCLC. Libtayo in combination with platinum?based chemotherapy is indicated for the first?line treatment of adult patients with NSCLC expressing PD-L1 (in ? 1% of tumour cells), with no EGFR, ALK or ROS1 aberrations, who have: locally advanced NSCLC who are not candidates for definitive chemoradiation, or metastatic NSCLC. Cervical Cancer Libtayo as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy. |
Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.
Data updated 14 days agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 3 | 130 | 70 | 15 | 183 | 18 | CA, EU, US | Sep 28, 2018 | Mar 1, 2010 |
| Malignant Lung Neoplasm | Approved | Phase 3 | 37 | 21 | 8 | 50 | 2 | US | Sep 28, 2018 | May 29, 2017 |
| Skin Carcinoma | Approved | Phase 3 | 15 | 4 | 3 | 25 | 1 | US | Sep 28, 2018 | Apr 7, 2016 |
| Malignant Kidney Neoplasm | Phase2 | Phase 2 | 6 | 5 | 0 | 9 | 0 |
Curated evidence
Clinical evidence (0)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
Data not yet available
Clinical trials
Trials with this intervention (191)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT06413680 | A First-In Human (FIH) Study to Find Out How Well REGN10597 Medicine Given Alone or in Combination With Cemiplimab Works in Adult Participants Who Have Cancer With Tumors That Have Spread in Their Body(BrILliance) | recruiting | Phase 1 / Phase 2 | 240 | Regeneron PharmaceuticalsINDUSTRY | 1 | Apr 28, 2026 | clinicaltrials |
| NCT04763616 | Study of Isatuximab and Cemiplimab in Relapsed or Refractory Natural Killer/T-cell Lymphoid Malignancy |