Trial Profile
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled Study of AG-120 in Previously-treated Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 15 May 2023
Price :
$35
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At a glance
- Drugs Ivosidenib (Primary)
- Indications Cholangiocarcinoma
- Focus Registrational; Therapeutic Use
- Acronyms ClarIDHy
- Sponsors Agios Pharmaceuticals
- 11 May 2023 According to a CStone Pharmaceuticals media release, Servier, a partner of CStone Pharmaceuticals announced European Commission approved Tuosuvo (ivonib tablets) for the treatment of patients with IDH1-mutated acute myeloid leukemia and cholangiocarcinoma.
- 15 Mar 2023 According to a CStone Pharmaceuticals media release, MAA approval is expected in E.U. in 2023.
- 24 Feb 2023 According to a Servier media release, the CHMP's positive opinion will be referred to the European Commission (EC) which will deliver a final decision in the coming months.