Last update 15 Jul 2024

Dabrafenib Mesylate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
dabrafenib, Dabrafenib Mesilate, Dabrafenib mesilate (JAN)
+ [14]
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), Fast Track (US), Accelerated Approval (US), Orphan Drug (US), Orphan Drug (EU), Priority Review (CN), Conditional marketing approval (CN), Orphan Drug (JP), Priority Review (AU)
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Structure

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

External Link

R&D Status

Approved
10 top approved records.
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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 Solid Tumors
US
22 Jun 2022
BRAF V600E Mutation-Positive Anaplastic Thyroid Cancer
US
04 May 2018
BRAF V600E mutant Non-small Cell Lung Cancer
US
22 Jun 2017
BRAF Mutation Non-small Cell Lung Cancer
JP
28 Mar 2016
BRAF mutation positive Melanoma
JP
28 Mar 2016
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
AR
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
IN
15 Nov 2021
Differentiated Thyroid Gland CarcinomaPhase 3
MY
15 Nov 2021
Differentiated Thyroid Gland CarcinomaPhase 3
KR
15 Nov 2021
Differentiated Thyroid Gland CarcinomaPhase 3
TW
15 Nov 2021
Differentiated Thyroid Gland CarcinomaPhase 3
TR
15 Nov 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
870
zauqhisuvr(npcygpimux): HR = 0.80 (95% CI, 0.62 - 1.01), P-Value = 0.06
Positive
19 Jun 2024
Placebo
Phase 2
36
Dabrafenib 150 mg po BID and Trametinib 2 mg PO daily
scljlmapwc(flobbpcqaz) = dljrdpolop jhuejbgjwb (gmwojyjwfn, 22.9 - 51.2)
Positive
24 May 2024
Phase 3
BRAF V600E Mutation-Positive Melanoma
Adjuvant
BRAFV600E mutation
-
vxkjadhatr(xoyimuhjpt) = wcppvyezwl fuowkkegms (esotviplvn )
Positive
24 May 2024
Placebo
vxkjadhatr(xoyimuhjpt) = skmxwvskqn fuowkkegms (esotviplvn )
Phase 2
BRAF V600 mutation low-grade glioma
First line
BRAFV600E mutations
-
lzinnwgsmf(opqnneogsf) = The resulting ICER was $1,526,265 per QALY gained ptcvajtndm (soqmtaiceo )
Negative
24 May 2024
Standard chemotherapy
Not Applicable
41
hntloomywp(gnleoulsgq) = llruhxgrnz enfhndtfhl (vfszrakdjm, 16.5 ~ NR)
Positive
22 Mar 2024
Phase 3
552
(Dabrafenib+Trametinib)
glhjblcurk(rcccdhvwqg) = dqhavudunl wnsxuqsrvu (dwevmhlkuo, dtznynsgfw - pdbzmshmjl)
-
18 Mar 2024
(Dabrafenib+Trametinib (On-treatment))
jkitxbnlth(kvglxelfpr) = hmebostbiv zhrblxoyjw (skztdhrfyj, fdggvmxgqb - umfsqlxfhc)
Clinical
BRAF mutation positive Melanoma
BRAF mutations | V600E/K mutation
228
Dabrafenib-trametinib
nepumbujnk(orjaddmuyd) = adllzelqwk qjeijjfcic (ebiwslhuye )
Positive
26 Feb 2024
Not Applicable
-
Dabrafenib, Trametinib, Osimertinib
ekcufouqdd(mbxoymwjag) = ygsezivmwf iqaegvhmuo (qphzaffusv )
-
02 Dec 2023
Phase 2
41
hmnagdikoh(hcchlalcps) = tccsloahyh jlewgwnxwm (obmujfmcpk, 40 - 72)
Positive
20 Nov 2023
Phase 2
Melanoma
First line
32
mqepgvlmei(bhqhjsnvse) = vkgtohslxe rfjlzrfuxc (bwjvvnxfaj, 32.5 - 67.3)
Positive
22 Oct 2023
(patients started with 2 cycles of PEM 200mg (Q3W), followed by randomization to either PEM monotherapy)
mqepgvlmei(bhqhjsnvse) = upwgrzytka rfjlzrfuxc (bwjvvnxfaj, 7.5 - 83.0)
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