Drug Type Monoclonal antibody |
Synonyms Lambrolizumab, Pembrolizumab (Genetical Recombination), Pembrolizumab (genetical recombination) (JAN) + [12] |
Target |
Action inhibitors |
Mechanism PD-1 inhibitors(Programmed cell death protein 1 inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (04 Sep 2014), |
RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), PRIME (European Union), Priority Review (China), Breakthrough Therapy (China), Orphan Drug (Japan), Orphan Drug (Australia), Priority Review (Australia), Conditional marketing approval (China) |


| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D10574 | Pembrolizumab |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Carcinoma of urinary bladder, invasive | European Union | 01 Jul 2026 | |
| Carcinoma of urinary bladder, invasive | Iceland | 01 Jul 2026 | |
| Carcinoma of urinary bladder, invasive | Liechtenstein | 01 Jul 2026 | |
| Carcinoma of urinary bladder, invasive | Norway | 01 Jul 2026 | |
| Platinum-Resistant Fallopian Tube Carcinoma | China | 23 Jun 2026 | |
| Platinum-Resistant Primary Peritoneal Carcinoma | European Union | 22 Apr 2026 | |
| Platinum-Resistant Primary Peritoneal Carcinoma | Iceland | 22 Apr 2026 | |
| Platinum-Resistant Primary Peritoneal Carcinoma | Liechtenstein | 22 Apr 2026 | |
| Platinum-Resistant Primary Peritoneal Carcinoma | Norway | 22 Apr 2026 | |
| Platinum-Resistant Epithelial Ovarian Carcinoma | European Union | 02 Apr 2026 | |
| Platinum-Resistant Epithelial Ovarian Carcinoma | Iceland | 02 Apr 2026 | |
| Platinum-Resistant Epithelial Ovarian Carcinoma | Liechtenstein | 02 Apr 2026 | |
| Platinum-Resistant Epithelial Ovarian Carcinoma | Norway | 02 Apr 2026 | |
| Mismatch repair-deficient Colonic Cancer | United States | 10 Feb 2026 | |
| Mismatch repair-deficient Colonic Cancer | United States | 10 Feb 2026 | |
| Neoplasms | United States | 10 Feb 2026 | |
| Neoplasms | United States | 10 Feb 2026 | |
| Ovarian Cancer | United States | 10 Feb 2026 | |
| Ovarian Cancer | United States | 10 Feb 2026 | |
| Muscle Invasive Bladder Carcinoma | United States | 21 Nov 2025 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Recurrent Platinum-Resistant Ovarian Carcinoma | NDA/BLA | United States | 20 Oct 2025 | |
| Small intestine carcinoma | NDA/BLA | European Union | 25 Mar 2022 | |
| Non-small cell lung cancer stage I | Phase 3 | United States | 04 May 2026 | |
| Non-small cell lung cancer stage I | Phase 3 | Australia | 04 May 2026 | |
| Non-small cell lung cancer stage I | Phase 3 | Canada | 04 May 2026 | |
| Non-small cell lung cancer stage I | Phase 3 | France | 04 May 2026 | |
| Non-small cell lung cancer stage I | Phase 3 | Germany | 04 May 2026 | |
| Non-small cell lung cancer stage I | Phase 3 | Greece | 04 May 2026 | |
| Non-small cell lung cancer stage I | Phase 3 | Hungary | 04 May 2026 | |
| Non-small cell lung cancer stage I | Phase 3 | Israel | 04 May 2026 |
Phase 2 | 30 | Pembrolizumab and Carboplatin/ Paclitaxel | zlryhnsdct(ocyyljumkz) = gcyheysipr kuqofyucel (xmgmayhmsh ) View more | Negative | 31 Dec 2026 | ||
Not Applicable | 331 | akcraxzdpm(mkmleekjig): P-Value = 0.534 View more | Positive | 12 Sep 2026 | |||
Not Applicable | 246 | dcarnkyrxc(nvxldscuag) = vqkuokhqcy zkyoovnwov (esftchbssr ) View more | Positive | 12 Sep 2026 | |||
Phase 2 | Malignant Pleural Mesothelioma Neoadjuvant | 41 | gumhqszlqk(oqnshqunfr) = khxzdwhztf ryboixfqfx (xxqggdjtpb ) View more | Negative | 12 Sep 2026 | ||
Phase 3 | metastatic non-small cell lung cancer First line | 1,175 | Pembrolizumab plus chemotherapy | nypoqpdkfb(jvvhrloqhh) = hczsxyhigg zqavsnfohi (fsuudzujdy, 12.7 - 20.0) | Positive | 12 Sep 2026 | |
Chemotherapy | nypoqpdkfb(jvvhrloqhh) = bphwkawjgg zqavsnfohi (fsuudzujdy, 3.3 - 10.3) | ||||||
Not Applicable | 61 | preoperative chemoradiotherapy (CRT) | fguggjkiue(luxrtgmiin): P-Value = 0.128 View more | Positive | 12 Sep 2026 | ||
perioperative immune checkpoint inhibitors (stage II-III NSCLC) | |||||||
Not Applicable | 4 | lejfelvspv(lpdgpvsriv) = xwjcnrzntq flmnorgdgq (tgatebogkw ) | Positive | 12 Sep 2026 | |||
lejfelvspv(lpdgpvsriv) = gzxvgdirlm flmnorgdgq (tgatebogkw ) | |||||||
Not Applicable | 369 | (Completion group) | ppqzzwzjwg(jehbysomhj) = bnbrirxfpq tburfcmpti (rtmjxsllgx ) View more | Positive | 12 Sep 2026 | ||
(Discontinuation group) | ppqzzwzjwg(jehbysomhj) = iwwjhtxbnd tburfcmpti (rtmjxsllgx ) View more | ||||||
Phase 3 | metastatic non-small cell lung cancer First line | 321 | epcmvrznhx(trnwpyhmmd): HR = 0.8 (95.0% CI, 0.66 - 0.96) | Positive | 12 Sep 2026 | ||
Ipilimumab-nivolumab plus chemotherapy | |||||||
Not Applicable | Non-Small Cell Lung Cancer Neoadjuvant | 110 | kqnryygzwj(exkzlxaicn) = wgcorzycwx kfdmryljwl (lpwebvyshn ) View more | Positive | 12 Sep 2026 |






