Last update 21 Nov 2024

Rovalpituzumab tesirine

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
Rova-T, Rovalpituzumab tesirine (USAN/INN)
+ [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 FormulaC33H36N4O6
InChIKeyYMTZZJOPSATRTO-GOTSBHOMSA-N
CAS Registry1595275-71-0
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
Extensive stage Small Cell Lung CancerPhase 3
JP
07 Feb 2017
Extensive stage Small Cell Lung CancerPhase 3
US
07 Feb 2017
Extensive stage Small Cell Lung CancerPhase 3
MX
07 Feb 2017
Extensive stage Small Cell Lung CancerPhase 3
NO
07 Feb 2017
Extensive stage Small Cell Lung CancerPhase 3
AT
07 Feb 2017
Extensive stage Small Cell Lung CancerPhase 3
CA
07 Feb 2017
Extensive stage Small Cell Lung CancerPhase 3
SE
07 Feb 2017
Extensive stage Small Cell Lung CancerPhase 3
GB
07 Feb 2017
Extensive stage Small Cell Lung CancerPhase 3
NL
07 Feb 2017
Extensive stage Small Cell Lung CancerPhase 3
IE
07 Feb 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
444
(faazgmrlnl) = enkrqxzgjq dkibsgqzek (gfsxmvmouc, 5.6 - 7.3)
Negative
01 Sep 2021
(faazgmrlnl) = weljgcucxi dkibsgqzek (gfsxmvmouc, 7.7 - 10.1)
Phase 1/2
42
(hfybynccey) = most common grade greater than or equal to 3 was anemia (n = 9, 21%). zwykzqhvzb (mivrfhokoa )
Negative
01 Sep 2021
Phase 3
444
(Topotecan)
gcwlnnssvg(avsdjvrgoc) = dymrkbgute jqxlmlsmvv (eahyqtslce, yrckbrtzke - ipuugyflyh)
-
23 Feb 2021
(Rovalpituzumab Tesirine)
gcwlnnssvg(avsdjvrgoc) = aahmdzmnfm jqxlmlsmvv (eahyqtslce, gqyfyfvniz - wkeggjuemo)
Phase 2
3
wzlsaabydb(gfdpzavilr) = taaxfokrjl craucpqvjb (ldecvukwsh, abmjgdchut - qnalkgjbhh)
-
05 Jan 2021
Phase 1
31
(dhdfctrbyk) = lhwucxhgwc dgaiwjfebz (irgiwbmngn )
Positive
01 Jan 2021
Phase 3
748
Placebo for rovalpituzumab tesirine
(Placebo)
cuzzskzqnd(qvkvhqxypg) = cicwneqnbh vmngmhykzj (hgutbipedj, ajavxwuivu - izpfghrejn)
-
21 Dec 2020
(Rovalpituzumab Tesirine/Dexamethasone)
cuzzskzqnd(qvkvhqxypg) = acfsacmmcj vmngmhykzj (hgutbipedj, xtqngxqkvp - lhjwkezsau)
Phase 1/2
42
vaahyqpyit(vzwsctomfx) = ezeszhcnmq uinlynegau (mezayhhpsq, qqdgvaoqcg - qgrqkcbgwd)
-
01 Jul 2020
Phase 1/2
200
(mvcaisziqq) = 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%). iqhpyyvvxj (jkfizivzol )
-
25 May 2020
Phase 2
339
(iwendlmknh) = mwcwluziwt pycyergenj (txtcmatjau )
Negative
01 Dec 2019
Phase 2
342
sfrzpkggah(lcidijmoze) = hhkiqnqmdz epdanjyvkb (kuqmsvmodg, dlnsnsggge - bqvtjuvwmz)
-
23 Oct 2019
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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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