Ivosidenib (3) – Tibsovo®
Acute myeloid leukaemia with the IDH1 R132 mutation, first-line treatment, in combination with azacitidine
Characteristics
| Start date | 01.03.2026 |
|---|---|
| Resolution | 20.08.2026 – active procedure |
| INN | Ivosidenib |
| Brand name | Tibsovo® |
| Pharm. company | Servier Deutschland GmbH |
| G-BA Procedure ID | D-1304 |
| Therapeutic area | Oncological diseases Orphan (turnover limit) |
| Reason for procedure | Reassessment: Orphan turnover exceeded |
Associated procedures
| Ivosidenib (4) | Tibsovo® | Servier Deutschland GmbH | Cholangiocarcinoma with an IDH1 R132 mutation, following at least one prior course of treatment | n.d. | active procedure Orphan (turnover limit) | |
| Ivosidenib (3) | Tibsovo® | Servier Deutschland GmbH | Acute myeloid leukaemia with the IDH1 R132 mutation, first-line treatment, in combination with azacitidine | n.d. | active procedure Orphan (turnover limit) | |
| Ivosidenib (2) | Tibsovo® | Servier Deutschland GmbH | Cholangiocarcinoma with IDH1-R132 mutation, after at least 1 prior therapy | 80–160 | 100% Hint for non-quantifiable additional benefit Orphan | |
| Ivosidenib (1) | Tibsovo® | Servier Deutschland GmbH | Acute myeloid leukemia with IDH1-R132 mutation, first-line, combination with azacitidine | 45–125 | 100% Indication of major additional benefit Orphan |
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