France-based pharmaceutical company Servier has announced that the US Food and Drug Administration (FDA) has granted market approval for its drug Tibsovo (ivosidenib) for the treatment of recurrent or refractory (R/R) myelodysplastic syndrome (MDS) with IDH1 mutation. This marks the fifth indication for the drug in the IDH1 mutant cancer field and cements its position as the world’s first and only targeted therapy for this specific subgroup of recurrent or refractory MDS patients.
Tibsovo’s Development and Licensing
Tibsovo was originally developed by US-based Agios Pharmaceuticals. In June 2018, CStone Pharmaceuticals (HKG: 2616) licensed the commercial and development rights for Tibsovo in Greater China. Since then, the drug has obtained marketing approvals in several regions, including the US, European Union, Australia, United Arab Emirates (UAE), and China.
Approvals and Treatment Options in China and the US
In China, Tibsovo received approval in January 2022 for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (r/r AML) with IDH1 mutations. In the US, Tibsovo is approved for use in combination with azacitidine or as a monotherapy for newly diagnosed IDH1 mutant AML patients who are aged 75 or above, or those with comorbidities that preclude them from receiving intensive induction chemotherapy. Additionally, it is approved for IDH1 mutation recurrence or refractory AML patients, and for treated, locally advanced, or metastatic IDH1 mutation cholangiocarcinoma patients.- Flcube.com
