Drug Type Monoclonal antibody |
Synonyms Lambrolizumab, Pembrolizumab (Genetical Recombination), Pembrolizumab (USAN) + [10] |
Target |
Mechanism PD-1 inhibitors(Programmed cell death protein 1 inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (04 Sep 2014), |
RegulationConditional marketing approval (CN), PRIME (EU), Orphan Drug (JP), Priority Review (AU), Breakthrough Therapy (US), Accelerated Approval (US) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D10574 | Pembrolizumab |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Advanced Renal Cell Carcinoma | LI | 17 Jul 2015 | |
Advanced Renal Cell Carcinoma | IS | 17 Jul 2015 | |
Advanced Renal Cell Carcinoma | NO | 17 Jul 2015 | |
Advanced Renal Cell Carcinoma | EU | 17 Jul 2015 | |
Gastroesophageal junction adenocarcinoma | IS | 17 Jul 2015 | |
Gastroesophageal junction adenocarcinoma | LI | 17 Jul 2015 | |
Gastroesophageal junction adenocarcinoma | EU | 17 Jul 2015 | |
Gastroesophageal junction adenocarcinoma | NO | 17 Jul 2015 | |
HER2 negative Gastroesophageal Junction Adenocarcinoma | LI | 17 Jul 2015 | |
HER2 negative Gastroesophageal Junction Adenocarcinoma | NO | 17 Jul 2015 | |
HER2 negative Gastroesophageal Junction Adenocarcinoma | IS | 17 Jul 2015 | |
HER2 negative Gastroesophageal Junction Adenocarcinoma | EU | 17 Jul 2015 | |
Locally Advanced Lung Non-Small Cell Carcinoma | IS | 17 Jul 2015 | |
Locally Advanced Lung Non-Small Cell Carcinoma | LI | 17 Jul 2015 | |
Locally Advanced Lung Non-Small Cell Carcinoma | NO | 17 Jul 2015 | |
Locally Advanced Lung Non-Small Cell Carcinoma | EU | 17 Jul 2015 | |
Unresectable Melanoma | EU | 17 Jul 2015 | |
Unresectable Melanoma | LI | 17 Jul 2015 | |
Unresectable Melanoma | IS | 17 Jul 2015 | |
Melanoma | US | 04 Sep 2014 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Uterine Cervical Cancer | NDA/BLA | CN | 04 Apr 2024 | |
Transitional Cell Carcinoma | NDA/BLA | CN | 28 Mar 2024 | |
Recurrent Endometrial Cancer | NDA/BLA | US | 21 Feb 2024 | |
ER-positive/HER2-negative Breast Cancer | NDA/BLA | CN | 08 Nov 2023 | |
Locally Advanced Cholangiocarcinoma | NDA/BLA | US | 08 Jun 2023 | |
Metastatic Biliary Tract Carcinoma | NDA/BLA | US | 08 Jun 2023 | |
Unresectable Biliary Tract Carcinoma | NDA/BLA | US | 08 Jun 2023 | |
Small intestine carcinoma | NDA/BLA | EU | 25 Mar 2022 | |
Stomach Cancer | NDA/BLA | EU | 25 Mar 2022 |
Not Applicable | - | xappkuvyoq(wyqcwlhyzh) = led to discontinuations in 2 patients (at 2 and 6 months) ceohqgysjc (cbckookrqc ) View more | - | 08 Dec 2024 | |||
Not Applicable | - | Pembrolizumab plus AVD and RT | uziohzfsob(xqwsfsgjmo) = treatment-related adverse events (AEs) were reported in 8 patients (80%); grade 3 or 4 treatment-related AEs occurred in 4 patients (40%). No patients discontinued or died due to treatment-related AEs. Seven patients (67%) had pembrolizumab-related AEs, 3 of whom (30%) had a grade 3 event (vomiting, lymphocyte count decreased, white blood cell count decreased). Immune-mediated AEs occurred in 3 patients (30%; all grade 1 or 2 hypothyroidism) cnybaicbgb (mtyfxtupku ) | - | 08 Dec 2024 | ||
Not Applicable | - | Pembrolizumab plus COPDAC-28 with RT | (fcvfhhakbw) = dupzlxfork pnllhcqcjs (auqyauckqu, 93 - 100) View more | - | 08 Dec 2024 | ||
Pembrolizumab plus COPDAC-28 without RT | ygtgudomyj(rjnkrwqzob) = rluqjxiifs uvmvqgxljr (nugpduebmp ) | ||||||
Phase 2 | 28 | hmnhryrcuo(ffmezfgyit) = fvqangqkcn jlhwapknwe (tdhweoavce, onhjytlaiu - yrjdozxosk) View more | - | 15 Nov 2024 | |||
Phase 1/2 | 12 | (Cohort 1B: Checkpoint Inhibitor Naïve) | woworgapis(nhawwdgawl) = jegdfdkaoi zyfrrlijtp (yghcbnthqu, azmbikbolf - zmdgvseeuh) View more | - | 14 Nov 2024 | ||
(Cohort 1B: Checkpoint Inhibitor PD-1/PD-L1 Failure) | woworgapis(nhawwdgawl) = taohgqppbb zyfrrlijtp (yghcbnthqu, waxkyzdqxi - wkvohlyqtq) View more | ||||||
Phase 1 | 35 | (Dose Expansion Arm A, Melanoma) | ylcvseihoc(wrdswemjjv) = xinxmfxbuv gudknhryrt (koxtfdbvyf, kijevppnku - dtfnbkssbs) View more | - | 12 Nov 2024 | ||
(Dose Expansion Arm B, HNSCC) | ylcvseihoc(wrdswemjjv) = ppcipfrnsk gudknhryrt (koxtfdbvyf, wgnnooqiva - wqqawyzjsw) View more | ||||||
Phase 2 | 17 | noayhnzixn(fytcevqkph) = ymdgvnlzil hcciyswynq (azdngqviaj, sonhpyiovc - tdfnpqfeex) View more | - | 07 Nov 2024 | |||
Phase 2 | 243 | Dostarlimab + CT | (euirzossds) = zetpfjruun azancgfiox (bbmrvumygf, 14.5 - 27.3) | Positive | 05 Nov 2024 | ||
Pembrolizumab + CT | (euirzossds) = rqtovhmwfd azancgfiox (bbmrvumygf, 11.6 - 19.3) | ||||||
NCT05200559 (SITC2024) Manual | Phase 1 | 16 | (ptkkhmxwpt) = no DLTs were noted in DL 1 (3 mcg/kg) n=3, DL2 (6 mcg/kg) n=2, and DL3 (9 mcg/kg) n=2. One patient experienced a DLT at in DL4 (12 mcg/kg) n=9 and she was able to safely continue treatment. vmfhwendxt (ulqinldzlr ) View more | Positive | 05 Nov 2024 | ||
Phase 1/2 | 30 | (chmeocifra) = None meffbkrrsg (ltzqogckmj ) View more | Positive | 05 Nov 2024 | |||