Servier’s Tibsovo (ivosidenib) Receives EC’s Approval for IDH1-Mutated Acute Myeloid Leukemia and IDH1-Mutated Cholangiocarcinoma
Shots:
- The EC has approved Tibsovo as a targeted therapy in 2 indications i.e., in combination with azacitidine for adult patients with newly diagnosed AML with IDH1 R132 mutation & as monotx. for LA or metastatic cholangiocarcinoma with an IDH1 R132 mutation
- The approval was based on the results from the P-III study (AGILE) in AML, published in the NEJM evaluating Tibsovo + azacitidine vs PBO + azacytidine which showed an improvement in EFS & OS, m-OS (24.0 vs 7.9mos.) & 2EPs incl. CR rate, OS, CRh rate & ORR
- The approval in cholangiocarcinoma was based on the P-III trial (ClarIDHy) which showed an improvement in 1EPs of PFS, m-PFS (2.7 vs 1.4mos.), 32% vs 22% remained free of progression or death @6 & 12mos.Servier, Tibsovo, ivosidenib, IDH1-Mutated, Acute Myeloid Leukemia, Cholangiocarcinoma, Regulatory, EC, Approval
Ref: PRNewswire | Image: Servier
Rleated News:- Servier’s Tibsovo (ivosidenib) Receives the US FDA's Approval for the Treatment of IDH1-mutated Acute Myeloid Leukemia
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