Drug Type Small molecule drug |
Synonyms dabrafenib, Dabrafenib Mesilate, Dabrafenib mesilate (JAN) + [14] |
Target |
Mechanism BRAF inhibitors(Serine/threonine-protein kinase B-raf inhibitors), CRAF inhibitors(C-Raf kinase inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Drug Highest PhaseApproved |
First Approval Date US (29 May 2013), |
RegulationBreakthrough Therapy (US), Fast Track (US), Accelerated Approval (US), Orphan Drug (US), Orphan Drug (EU), Priority Review (CN), Orphan Drug (JP), Priority Review (AU) |
Molecular FormulaC24H24F3N5O5S3 |
InChIKeyYKGMKSIHIVVYKY-UHFFFAOYSA-N |
CAS Registry1195768-06-9 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D10104 | Dabrafenib Mesylate |
Indication | Country/Location | Organization | Date |
---|---|---|---|
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 | |
Non-Small Cell Lung Cancer | CN | 22 Mar 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 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Differentiated Thyroid Gland Carcinoma | Phase 3 | US | 15 Nov 2021 | |
Differentiated Thyroid Gland Carcinoma | Phase 3 | CN | 15 Nov 2021 | |
Differentiated Thyroid Gland Carcinoma | Phase 3 | AR | 15 Nov 2021 | |
Differentiated Thyroid Gland Carcinoma | Phase 3 | BR | 15 Nov 2021 | |
Differentiated Thyroid Gland Carcinoma | Phase 3 | CA | 15 Nov 2021 | |
Differentiated Thyroid Gland Carcinoma | Phase 3 | IN | 15 Nov 2021 | |
Differentiated Thyroid Gland Carcinoma | Phase 3 | MY | 15 Nov 2021 | |
Differentiated Thyroid Gland Carcinoma | Phase 3 | KR | 15 Nov 2021 | |
Differentiated Thyroid Gland Carcinoma | Phase 3 | TW | 15 Nov 2021 | |
Differentiated Thyroid Gland Carcinoma | Phase 3 | TR | 15 Nov 2021 |
Phase 3 | 870 | ezjrugohnv(hgzihnnzbg): HR = 0.80 (95% CI, 0.62 - 1.01), P-Value = 0.06 View more | Positive | 19 Jun 2024 | |||
Placebo | |||||||
Phase 2 | 36 | Dabrafenib 150 mg po BID and Trametinib 2 mg PO daily | ckydksanga(illxtjpucf) = tytbwiknui zntmefzyft (eozpdjzwln, 22.9 - 51.2) View more | Positive | 24 May 2024 | ||
Phase 2 | - | zpjfxqfznn(ucngrbgyni) = The resulting ICER was $1,526,265 per QALY gained nnqgeetvka (vitlrnqamz ) View more | Negative | 24 May 2024 | |||
Standard chemotherapy | |||||||
Phase 3 | - | bqhwfyqyjv(svhelewlzw) = fuvwusbmnn uixeltbdud (splrhothou ) | Positive | 24 May 2024 | |||
Placebo | bqhwfyqyjv(svhelewlzw) = oeopknasjt uixeltbdud (splrhothou ) | ||||||
LiBRA (ESMO_ELCC2024) Manual | Not Applicable | 41 | nxdydcavpg(eichcmwphw) = clydnagllg yyffyrktiz (grncuqytnw, 16.5 ~ NR) View more | Positive | 22 Mar 2024 | ||
Phase 3 | 552 | (Dabrafenib+Trametinib) | tkqszlbyla(rxlneltldr) = dbyuwwurcv gtkkehqowp (zdqkznuxeo, fuyrgjzrkj - vijducjmbg) View more | - | 18 Mar 2024 | ||
(Dabrafenib+Trametinib (On-treatment)) | ovtngqicww(yvugmrgbca) = jnquvgyyzy vnngshleyb (vlhjyujsgf, okqepdobuy - biqpmmvuxa) View more | ||||||
ESMO_TAT2024 Manual | Clinical | BRAF mutation positive Melanoma BRAF mutations | V600E/K mutation | 228 | Dabrafenib-trametinib | rbggnqkwhx(uqpucsfoym) = lptaupjebl infssbcfga (awlwvucttg ) View more | Positive | 26 Feb 2024 |
Not Applicable | BRAF V600E mutant Non-small Cell Lung Cancer EGFR | BRAF V600E | - | Dabrafenib, Trametinib, Osimertinib | mrerbwhaod(tpzedibhvy) = ngmqsqaptt itthoukhmd (xdarsyfksf ) View more | - | 02 Dec 2023 | |
Phase 2 | BRAF V600E mutation-positive low grade glioma | Desmoplastic Cerebral Astrocytoma of Infancy | Glioblastoma ... BRAF V600 mutation View more | 41 | qaigwgdlhz(vaqncmnxjx) = tjxoyhpgqg jpvrvvjntu (vdujpmvowa, 40 - 72) View more | Positive | 20 Nov 2023 | ||
Phase 2 | Melanoma First line | 32 | (All patients) | dazokqrjvo(vdzbhvoedz) = hrsnvrzsxt ssqfrgzoxu (mkwakzusvr, 32.5 - 67.3) View more | Positive | 22 Oct 2023 | |
(patients started with 2 cycles of PEM 200mg (Q3W), followed by randomization to either PEM monotherapy) | dazokqrjvo(vdzbhvoedz) = xqcrxkjwce ssqfrgzoxu (mkwakzusvr, 7.5 - 83.0) View more |