TAFINLAR

Peak

dabrafenib

NDAORALCAPSULEPriority Review
Approved
Mar 2023
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
21

Mechanism of Action

50 values of 0.65, 0.5, and 1.84 nM for BRAF V600E, BRAF V600K, and BRAF V600D enzymes, respectively. Dabrafenib also inhibits wild-type BRAF and CRAF kinases with IC 50 values of 3.2 and 5.0 nM, respectively, and other kinases, such as SIK1, NEK11, and LIMK1 at higher concentrations. Some…

Clinical Trials (5)

NCT07440290Phase 2/3Not Yet Recruiting

DETERMINE Trial Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and Teenage/Young Adult Patients With BRAF V600 Mutation-Positive Cancers.

Started Feb 2026
30 enrolled
Haematological MalignancyMalignant NeoplasmLymphoproliferative Disorders+16 more
NCT06262919N/ARecruiting

Special Drug Use-results Surveillance of Tafinlar/Mekinist

Started Feb 2024
110 enrolled
BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid Tumor
NCT05868629N/ARecruiting

Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors

Started Feb 2024
40 enrolled
Rare Unresectable or Metastatic BRAF V600E Mutation-positive Solid Tumors
NCT06557291N/ACompleted

Relapse-Free Survival With Adjuvant Dabrafenib/Trametinib Therapy in Patients With BRAF V600-mutated Stage III/IV Melanoma

Started Oct 2022
38 enrolled
BRAF V600 Mutated-Stage III/IV Melanoma
NCT04903119Phase 1Recruiting

Nilotinib Plus Dabrafenib/Trametinib or Encorafenib/Binimetinib in Metastatic Melanoma

Started Jun 2022
30 enrolled
Metastatic MelanomaBRAF Gene Mutation

Loss of Exclusivity

LOE Date
Dec 29, 2038
156 months away
Patent Expiry
Dec 29, 2038
Exclusivity Expiry
Sep 16, 2030

Patent Records (5)

Patent #ExpiryTypeUse Code
7994185
Jan 20, 2030
SubstanceProduct
8415345
Jan 20, 2030
SubstanceProduct
8415345*PED
Jul 20, 2030
7994185*PED
Jul 20, 2030
8703781
Oct 15, 2030
SubstanceProduct
U-3565