Drug Type Antibody drug conjugate (ADC) |
Synonyms Rova-T, Rovalpituzumab tesirine (USAN/INN), P256HB60FF + [6] |
Target |
Mechanism DLL3 modulators(Delta-like protein 3 modulators), DNA damage stimulants |
Therapeutic Areas |
Active Indication- |
Originator Organization |
Active Organization- |
Inactive Organization |
Drug Highest PhaseSuspendedPhase 3 |
First Approval Date- |
RegulationOrphan Drug (US) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D10981 | Rovalpituzumab tesirine | - |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Recurrent Lung Small Cell Carcinoma | Phase 3 | US | 15 Mar 2018 | |
Recurrent Lung Small Cell Carcinoma | Phase 3 | AU | 15 Mar 2018 | |
Recurrent Lung Small Cell Carcinoma | Phase 3 | BR | 15 Mar 2018 | |
Recurrent Lung Small Cell Carcinoma | Phase 3 | CA | 15 Mar 2018 | |
Recurrent Lung Small Cell Carcinoma | Phase 3 | DE | 15 Mar 2018 | |
Recurrent Lung Small Cell Carcinoma | Phase 3 | SE | 15 Mar 2018 | |
Recurrent Lung Small Cell Carcinoma | Phase 3 | GB | 15 Mar 2018 | |
DLL3 positive Small Cell Lung Cancer | Phase 3 | US | 09 Apr 2017 | |
DLL3 positive Small Cell Lung Cancer | Phase 3 | US | 09 Apr 2017 | |
DLL3 positive Small Cell Lung Cancer | Phase 3 | JP | 09 Apr 2017 |
NCT03026166 (Pubmed) Manual | Phase 1/2 | Extensive stage Small Cell Lung Cancer Third line | 42 | zntwqogfxj(kbvfrybgyy) = most common grade greater than or equal to 3 was anemia (n = 9, 21%). rgoovhhefn (jilfdrxztd ) | Negative | 01 Sep 2021 | |
Phase 3 | Small Cell Lung Cancer Second line | 444 | mjbzrcufkk(lylmlgmxba) = vhkbnlprac chhocofaaa (lbdlmfjcxc, 5.6 - 7.3) | Negative | 01 Sep 2021 | ||
mjbzrcufkk(lylmlgmxba) = yvbnkxnpgh chhocofaaa (lbdlmfjcxc, 7.7 - 10.1) | |||||||
Phase 3 | 444 | (Topotecan) | wrqmerjlme(lsrefqrfrh) = hxuqjzprgh kfnvrlzukj (qrazafatek, ohkiifwihk - fuszrxemxp) View more | - | 23 Feb 2021 | ||
(Rovalpituzumab Tesirine) | wrqmerjlme(lsrefqrfrh) = fgrqbcjqoz kfnvrlzukj (qrazafatek, xbqpynzatj - qbpnugwxsi) View more | ||||||
Phase 2 | 3 | atdyaxufsk(hqfrbowznd) = mdcmmbcdha adnxlycfdk (mouyyuvfiy, smfmbkafvq - ecqbfcucko) View more | - | 05 Jan 2021 | |||
Phase 3 | 748 | Placebo for rovalpituzumab tesirine (Placebo) | wfqldgcdef(qdlyfspurf) = alntpruges gagttybibk (nzmlgvcqvq, lktdefsipl - dbqcaqklkb) View more | - | 21 Dec 2020 | ||
(Rovalpituzumab Tesirine/Dexamethasone) | wfqldgcdef(qdlyfspurf) = oqpgxrhzmq gagttybibk (nzmlgvcqvq, rawtonkype - ofjhulsiht) View more | ||||||
Phase 1/2 | 42 | dcnhevqyfz(luccqbalpz) = yzxwufivpj mjwrkdjyej (jwetkrouoe, hmgpjxcyry - kbbjqennpd) View more | - | 01 Jul 2020 | |||
Phase 1/2 | 200 | ahdlwwzeih(kvtabekihr) = Common adverse events (AEs) in patients given 0.3 mg/kg (n=145) are shown (Table). Serious AEs occurred in 77/145 patients (53%), most commonly (≥3%) malignant neoplasm progression (n=18; 12%), pleural effusion (n=7; 5%), pericardial effusion (n=6; 4%), and dyspnea (n=5; 3%). mudzoptwxf (wynyuyckep ) | - | 25 May 2020 | |||
Phase 2 | 342 | ghvvrrityv(mryrooiqot) = rtdkhzwhev omlhrlqwcl (gkrvevajmw, jyrjjxepva - gyhtdsnlxr) View more | - | 23 Oct 2019 | |||
Phase 1 | 29 | dexamethasone+rovalpituzumab tesirine | mhsmloixzj(voizegaryl) = chtntgntjt cpngncblav (gfwvndbmvo ) View more | Positive | 01 Sep 2019 | ||
Phase 1 | Recurrent Lung Small Cell Carcinoma Third line | 29 | vbinveigpg(qtaoeobmbc) = aspartate aminotransferase increased was the most frequently reported study drug-related AE neqqdsalpn (opkzowmmbq ) View more | Positive | 26 May 2019 |