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Association details:
| Biomarker: | IDH1 R132 |
|---|---|
| Cancer: | Cholangiocarcinoma |
| Drug: | Tibsovo (ivosidenib) (IDH1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Servier receives European Commission approval of Tibsovo® (ivosidenib tablets) in IDH1-mutated Acute Myeloid Leukemia and IDH1-mutated Cholangiocarcinoma
Published date:
05/10/2023
Excerpt:
Servier, a global pharmaceutical group, today announced that the European Commission (EC) has approved Tibsovo® (ivosidenib tablets) as a targeted therapy in two indications: in combination with azacitidine for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive standard induction chemotherapy; as well as in monotherapy for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy.
Source:
Title:
Study of AG-120 in Previously Treated Advanced Cholangiocarcinoma With IDH1 Mutations (ClarIDHy)
Excerpt:
...Have documented IDH1 gene-mutated disease (from a fresh tumor biopsy or the most recent banked tumor tissue available) based on central laboratory testing (R132C/L/G/H/S mutation variants tested)....
Trial ID:
Source:
Title:
Ivosidenib, Nivolumab, and Ipilimumab Combination in Previously Treated Subjects With Nonresectable or Metastatic IDH1 Mutant Cholangiocarcinoma
Excerpt:
...- Have documented IDH1 gene-mutated disease based on local testing procedure (R132C/L/G/H/S mutations variants tested)...
Trial ID:
More C2 evidence
Source:
Title:
An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma
Excerpt:
...- Have a documented IDH1 R132C, R132L, R132G, R132H, or R132S gene-mutated disease...
Trial ID:
