Drug Type Monoclonal antibody |
Synonyms Cemiplimab, cemiplimab, Cemiplimab (Genetical Recombination)(JAN) + [5] |
Target |
Action inhibitors |
Mechanism PD-1 inhibitors(Programmed cell death protein 1 inhibitors) |
Therapeutic Areas |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (28 Sep 2018), |
RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (Australia), Paediatric investigation plan (European Union) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | Cemiplimab-RWLC |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Metastatic Carcinoma to the Uterine Cervix | European Union | 17 May 2023 | |
Metastatic Carcinoma to the Uterine Cervix | Iceland | 17 May 2023 | |
Metastatic Carcinoma to the Uterine Cervix | Liechtenstein | 17 May 2023 | |
Metastatic Carcinoma to the Uterine Cervix | Norway | 17 May 2023 | |
Advanced Cervical Carcinoma | Japan | 23 Dec 2022 | |
Recurrent Cervical Cancer | Japan | 23 Dec 2022 | |
Uterine Cervical Cancer | Canada | 25 Mar 2022 | |
Advanced Skin Squamous Cell Carcinoma | European Union | 28 Jun 2019 | |
Advanced Skin Squamous Cell Carcinoma | Iceland | 28 Jun 2019 | |
Advanced Skin Squamous Cell Carcinoma | Liechtenstein | 28 Jun 2019 | |
Advanced Skin Squamous Cell Carcinoma | Norway | 28 Jun 2019 | |
Basal Cell Carcinoma | European Union | 28 Jun 2019 | |
Basal Cell Carcinoma | Iceland | 28 Jun 2019 | |
Basal Cell Carcinoma | Liechtenstein | 28 Jun 2019 | |
Basal Cell Carcinoma | Norway | 28 Jun 2019 | |
Locally Advanced Lung Non-Small Cell Carcinoma | European Union | 28 Jun 2019 | |
Locally Advanced Lung Non-Small Cell Carcinoma | Iceland | 28 Jun 2019 | |
Locally Advanced Lung Non-Small Cell Carcinoma | Liechtenstein | 28 Jun 2019 | |
Locally Advanced Lung Non-Small Cell Carcinoma | Norway | 28 Jun 2019 | |
Metastatic basal cell carcinoma | European Union | 28 Jun 2019 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Non-small cell lung cancer stage IIIA | Phase 3 | Austria | 01 Sep 2025 | |
Non-small cell lung cancer stage IIIA | Phase 3 | Estonia | 01 Sep 2025 | |
Non-small cell lung cancer stage IIIA | Phase 3 | France | 01 Sep 2025 | |
Non-small cell lung cancer stage IIIA | Phase 3 | Germany | 01 Sep 2025 | |
Non-small cell lung cancer stage IIIA | Phase 3 | Ireland | 01 Sep 2025 | |
Non-small cell lung cancer stage IIIA | Phase 3 | Italy | 01 Sep 2025 | |
Non-small cell lung cancer stage IIIA | Phase 3 | Singapore | 01 Sep 2025 | |
Non-small cell lung cancer stage IIIA | Phase 3 | Spain | 01 Sep 2025 | |
Non-small cell lung cancer stage IIIA | Phase 3 | Switzerland | 01 Sep 2025 | |
Recurrent Non-Small Cell Lung Cancer | Phase 3 | United States | 22 May 2025 |
Phase 3 | Non-Small Cell Lung Cancer First line | 466 | Cemiplimab+Chemotherapy | yisgubukli(uwtyptbqri) = ntgrkpqfur utknkgonpj (eikwkhtcth, 14.9 - 24.5) View more | Positive | 09 Sep 2025 | |
Chemotherapy | yisgubukli(uwtyptbqri) = kwdeagwxmy utknkgonpj (eikwkhtcth, 4.8 - 14.4) View more | ||||||
Phase 2 | 54 | bmsfgyzltr(ruiwglwjsy) = fkixntdbuk lbhkfywofg (nbbiupxnde, 1.5 - 4.2) View more | Positive | 09 Sep 2025 | |||
Phase 2 | Advanced Lung Non-Small Cell Carcinoma Second line | 40 | (Advanced Immunorefractory Metastatic NSCLC) | ryvzlyular(lupipknfmv) = fxkucfwpaf fdpdzqwrwc (wuhoibldju ) View more | Positive | 07 Sep 2025 | |
(squamous histology) | ryvzlyular(lupipknfmv) = krxgiwxusl fdpdzqwrwc (wuhoibldju ) View more | ||||||
Phase 3 | 710 | (22C3+/SP263+) | epsayyihsj(lyytpmwziy): HR = 0.52 (95.0% CI, 0.34 - 0.8) View more | Positive | 01 Sep 2025 | ||
platinum-doublet chemotherapy | |||||||
Phase 3 | 415 | rpcruhqnsh(qyapkgwifx): HR = 0.35 (95% CI, 0.17 - 0.72) View more | Positive | 21 Aug 2025 | |||
Placebo | |||||||
Phase 1 | 77 | kkrhfhxkxs(qpfzvvsrqn) = generally well tolerated with antitumor activity in the locoregional disease setting ixbdllhbza (zuyylmgsqf ) View more | Positive | 13 Jun 2025 | |||
Phase 3 | 415 | bqabukagiy(llhrhnawms): HR = 0.32 (95% CI, 0.20 - 0.51), P-Value = < 0.0001 View more | Positive | 30 May 2025 | |||
Placebo | |||||||
Phase 2 | 11 | ehrmoawges(ogrqvwztuc) = zffryxxcvi wnbbytfouo (vojpkrzuqt ) View more | Positive | 30 May 2025 | |||
Phase 1 | 24 | gpdliruann(grovuwsxwz) = rmpjmwpzhb notdloiezc (fggvpahkoz ) View more | Positive | 30 May 2025 | |||
Phase 2 | 79 | iiqiacojuq(yoiwtkyxnj) = pkuvcbkpjg igxwcgclkv (yhpauhavlg ) | Positive | 30 May 2025 |