Products

Date: 2017-06-15

Type of information: Positive opinion for the granting of the orphan status in the EU

Product name: (S)-1-(4-fluorophenyl)-1-(2-(4-(6-(1-methyl-1H-pyrazol-4-yl)pyrrolo[2,1-f][1,2,4]triazin-4- yl)piperazin-yl)pyrimidin-5-yl)ethan-1-amine

Compound: (S)-1-(4-fluorophenyl)-1-(2-(4-(6-(1-methyl-1H-pyrazol-4-yl)pyrrolo[2,1-f][1,2,4]triazin-4- yl)piperazin-yl)pyrimidin-5-yl)ethan-1-amine

Therapeutic area: Cancer - Oncology - Rare diseases

Action mechanism:

Company: PhaRA (Belgium)

Disease: gastrointestinal stromal tumours (GIST)

Latest news:

• On June 15, 2017, the Committee for Orphan Medicinal Products (COMP) has recommended the granting of an orphan designation for (S)-1-(4-fluorophenyl)-1-(2-(4-(6-(1-methyl-1H-pyrazol-4-yl)pyrrolo[2,1-f][1,2,4]triazin-4- yl)piperazin-yl)pyrimidin-5-yl)ethan-1-amine for treatment of gastrointestinal stromal tumours.

Patents:

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization:

UE authorization:

Favourable opinion UE:

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes