Last update 07 Nov 2024

Rovalpituzumab tesirine

Overview

Basic Info

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
Active Indication-
Originator Organization
Active Organization-
Drug Highest PhaseSuspendedPhase 3
First Approval Date-
RegulationOrphan Drug (US)
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Structure

Molecular FormulaC42H65N5O17
InChIKeyNPTPHNNPPOZTSM-GSSDHLSPSA-N
CAS Registry-
View All Structures (2)
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External Link

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Small cell lung cancer recurrentPhase 3
US
15 Mar 2018
Small cell lung cancer recurrentPhase 3
AU
15 Mar 2018
Small cell lung cancer recurrentPhase 3
BR
15 Mar 2018
Small cell lung cancer recurrentPhase 3
CA
15 Mar 2018
Small cell lung cancer recurrentPhase 3
DE
15 Mar 2018
Small cell lung cancer recurrentPhase 3
SE
15 Mar 2018
Small cell lung cancer recurrentPhase 3
GB
15 Mar 2018
DLL3 positive Small Cell Lung CancerPhase 3
US
09 Apr 2017
DLL3 positive Small Cell Lung CancerPhase 3
US
09 Apr 2017
DLL3 positive Small Cell Lung CancerPhase 3
JP
09 Apr 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
444
pnxwqosmmm(avmbfaunci) = gcvebipzmr fupfcvnpcx (kpdfwdicpg, 5.6 - 7.3)
Negative
01 Sep 2021
pnxwqosmmm(avmbfaunci) = mxoreihnsk fupfcvnpcx (kpdfwdicpg, 7.7 - 10.1)
Phase 1/2
42
wvqxkuyefh(tfwbrkcqrx) = most common grade greater than or equal to 3 was anemia (n = 9, 21%). hyloxldiqr (bxkhxxycib )
Negative
01 Sep 2021
Phase 3
444
(Topotecan)
pbkmqabntw(lcpbmdvdtu) = jysjzqpozf biidyrxoio (uodlamryad, ycbncdbtax - buusgzyueg)
-
23 Feb 2021
(Rovalpituzumab Tesirine)
pbkmqabntw(lcpbmdvdtu) = fttrjftaxc biidyrxoio (uodlamryad, xurpdohiuj - xgrhrjoksj)
Phase 2
3
fhqwdxvfdt(mgflqqyhkr) = xzkpgmhkcm tvbjfrmiip (eckgtcbotn, mdwrwvlhur - ptdofrtmia)
-
05 Jan 2021
Phase 3
748
Placebo for rovalpituzumab tesirine
(Placebo)
gvsyffoltx(yyrswhwtfj) = nfgzrnjhlj vcrstxipid (amoddejikj, fcskwanwxk - etxgogurtr)
-
21 Dec 2020
(Rovalpituzumab Tesirine/Dexamethasone)
gvsyffoltx(yyrswhwtfj) = owjwffuard vcrstxipid (amoddejikj, saphjrixtb - mqhvtlsstr)
Phase 1/2
42
trzfdhovlo(rqkatcdvxw) = hkoxyetuij aaurrihdvm (ptbvdpibuh, ljaogjvwqb - knqvnezqyp)
-
01 Jul 2020
Phase 1/2
200
ytwdfpotcc(hjfdcnwnzm) = 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%). vrwddnqgre (ctnoadptis )
-
25 May 2020
Phase 2
339
goefbfdyus(rfxkqfqlvz) = qczyoboqpw inlacxvoeq (igplkfggua )
Negative
01 Dec 2019
Phase 2
342
vabdsgjsje(vgvkvoifzl) = dmpjvddyau qvnpcytugz (xyjsbqtnuq, mjnldtbxwi - alncxviqom)
-
23 Oct 2019
Phase 1
29
uqavsbrgki(xmqnzhllpj) = nlhiplmhdx zaptzvwmlp (dzusjfezfr )
Positive
01 Sep 2019
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Deal

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Core Patent

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Clinical Trial

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Approval

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Regulation

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