Last update 15 Nov 2024

Dabrafenib Mesylate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
dabrafenib, Dabrafenib Mesilate, Dabrafenib mesilate (JAN)
+ [16]
Mechanism
BRAF inhibitors(Serine/threonine-protein kinase B-raf inhibitors), CRAF inhibitors(C-Raf kinase inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationBreakthrough Therapy (US), Orphan Drug (US), Conditional marketing approval (CN), Orphan Drug (KR), Priority Review (AU), Accelerated Approval (US), Priority Review (CN), Fast Track (US), Orphan Drug (JP), Orphan Drug (EU)
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Structure

Molecular FormulaC24H24F3N5O5S3
InChIKeyYKGMKSIHIVVYKY-UHFFFAOYSA-N
CAS Registry1195768-06-9

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
BRAF mutation positive hairy cell leukemia
JP
24 Nov 2023
BRAF mutation Solid Tumors
JP
24 Nov 2023
High grade glioma
EU
15 Nov 2023
High grade glioma
IS
15 Nov 2023
High grade glioma
LI
15 Nov 2023
High grade glioma
NO
15 Nov 2023
Low grade glioma
EU
15 Nov 2023
Low grade glioma
IS
15 Nov 2023
Low grade glioma
LI
15 Nov 2023
Low grade glioma
NO
15 Nov 2023
BRAF V600E mutation-positive low grade glioma
US
16 Mar 2023
BRAF V600E Mutation-Positive Anaplastic Thyroid Cancer
US
04 May 2018
BRAF Mutation Non-small Cell Lung Cancer
JP
28 Mar 2016
BRAF mutation positive Melanoma
JP
28 Mar 2016
BRAF V600E mutant Non-small Cell Lung Cancer
KR
25 Sep 2014
BRAF V600E Mutation-Positive Solid Tumors
KR
25 Sep 2014
BRAF V600K Mutation-Positive Melanoma
US
09 Jan 2014
Melanoma
AU
27 Aug 2013
BRAF V600 mutation-positive Melanoma
EU
26 Aug 2013
BRAF V600 mutation-positive Melanoma
IS
26 Aug 2013
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Differentiated Thyroid Gland CarcinomaPhase 3
US
15 Nov 2021
Differentiated Thyroid Gland CarcinomaPhase 3
CN
15 Nov 2021
Differentiated Thyroid Gland CarcinomaPhase 3
CN
15 Nov 2021
Differentiated Thyroid Gland CarcinomaPhase 3
AR
15 Nov 2021
Differentiated Thyroid Gland CarcinomaPhase 3
AR
15 Nov 2021
Differentiated Thyroid Gland CarcinomaPhase 3
BR
15 Nov 2021
Differentiated Thyroid Gland CarcinomaPhase 3
BR
15 Nov 2021
Differentiated Thyroid Gland CarcinomaPhase 3
CA
15 Nov 2021
Differentiated Thyroid Gland CarcinomaPhase 3
CA
15 Nov 2021
Differentiated Thyroid Gland CarcinomaPhase 3
IN
15 Nov 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
4
Spartalizumab+Dabrafenib+trametinib
wjucnxtvbj(zjzoodwvjv) = yguxirmqpu xobundbfky (wmghwxzcoj, rytkxvdyir - acartdtovf)
-
30 Oct 2024
Not Applicable
-
jtnvabhbaq(jipdcdhmff) = VKH-like syndrome secondary to dabrafenib gwdwglssbq (nuzdoznmkm )
-
19 Sep 2024
ESMO2024
ManualManual
Not Applicable
Differentiated Thyroid Gland Carcinoma
Second line | First line
BRAFV600E mutation
37
jjremeztca(wslgqolerp) = cihvactaxc wyytskcmep (zwamwaoakt, 49.2 - 95.3)
Positive
16 Sep 2024
Dabrafenib+trametinib
(≥ 2nd line)
jjremeztca(wslgqolerp) = yymjhlcvtm wyytskcmep (zwamwaoakt, 16.3 - 61.6)
ESMO2024
ManualManual
Not Applicable
17
rjrayffjol(wcmlmbgqww) = None ilffciazid (akkxyvvtnw )
Positive
16 Sep 2024
Phase 2
19
Trametinib+PDR001
(lacking BRAFV600E- mutation)
edfvevoxzz(xcndbynqbq) = mqhxetdiyn tmlrbtodym (zonkxqsajv )
Positive
16 Sep 2024
dabrafenib+PDR001
(BRAFV600E- tumors after progression on BRAF-directed therapy)
edfvevoxzz(xcndbynqbq) = hfvdubbrkj tmlrbtodym (zonkxqsajv )
Not Applicable
225
Adjuvant dabrafenib plus trametinib (D+T)
sugtzasftw(aufryrxxct) = pyrexia being the most common (38.2%) pscpolfdur (mnstgllknu )
Positive
14 Sep 2024
(High-level AE management)
Phase 2
5
(Arm A (Dabrafenib, Trametinib, Hydroxychloroquine))
wurldgguwu(egacsklcnp) = udymlegdiu kjknniycom (felhwjvgnv, amntiwznpj - lumkzcoame)
-
22 Aug 2024
(Arm B (Dabrafenib, Trametinib, Placebo))
wurldgguwu(egacsklcnp) = wujjqbpxxo kjknniycom (felhwjvgnv, snewswqosa - sidjjprhfx)
Phase 2
Melanoma
Neoadjuvant
60
ftdkzsltbq(fascvicwun) = xcwlxwwoyl wdwrctsohw (gckngrzbvs )
Negative
21 Jun 2024
Sequential therapy (dabrafenib plus trametinib followed by pembrolizumab)
ftdkzsltbq(fascvicwun) = ijtxpktxem wdwrctsohw (gckngrzbvs )
Phase 3
870
ieeqosaisj(xnoypyzynq): HR = 0.80 (95% CI, 0.62 - 1.01), P-Value = 0.06
Positive
19 Jun 2024
Placebo
Phase 3
Melanoma
Adjuvant
870
igwxfercfc(ozwfdmneor) = the benefit was not significant fcjmjlkfcq (xsjfsgsskj )
Positive
19 Jun 2024
Placebo
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