Dabrafenib-trametinib companion diagnostic - bioMerieux/GlaxoSmithKline/Response GeneticsAlternative Names: BRAF V600 theranostic test; THxID-BRAF
Latest Information Update: 13 Jun 2014
At a glance
- Originator bioMerieux SA; GlaxoSmithKline
- Class Diagnostic agents
- Mechanism of Action
Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
On Fast track
Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.
Highest Development Phases
- Marketed Malignant melanoma
Most Recent Events
- 10 Jun 2014 Launched for Malignant melanoma in USA (unspecified route)
- 29 May 2013 Registered for Malignant melanoma in USA (unspecified route)
- 31 Jul 2012 Preregistration for Malignant melanoma in USA (unspecified route)