CStone Pharmaceuticals’ (HKG: 2616) French partner, Servier, has announced receiving two new indication approvals for Tibsovo (ivosidenib), a first-in-class IDH1 inhibitor, from the European Committee. This marks a significant expansion in the drug’s approved uses for treating specific types of leukemia and cholangiocarcinoma.
New Indications for Tibsovo in Europe
Tibsovo is now approved in Europe for the treatment of newly diagnosed acute myeloid leukemia (AML) with isocitric acid dehydrogenase 1 (IDH1) R132 mutation that is not suitable for standard induction chemotherapy combined with azacitidine. Additionally, it is approved for locally advanced or metastatic cholangiocarcinoma with IDH1 R132 mutation that has received at least one systemic therapy before treatment. The drug had previously received orphan drug designation (ODD) in Europe, highlighting its potential to address rare diseases.
CStone’s Licensing Agreement and Regional Approvals
Tibsovo was originally developed by US-based Agios, with CStone securing commercial and development rights in Greater China in June 2018. The drug received approval in China in January 2022 for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (r/r AML) with IDH1 mutations. Servier acquired the rights to the drug through the acquisition of Agios’ oncology business. Tibsovo’s approvals cover a range of patient groups, including newly diagnosed IDH1 mutant AML patients aged 75 or above, or those with comorbidities who cannot receive intensive induction chemotherapy; IDH1 mutation recurrence or refractory AML patients; and treated, locally advanced, or metastatic IDH1 mutation cholangiocarcinoma patients.
CStone’s Market Expansion Plans
CStone plans to pursue market filings for Tibsovo in additional regions, including Hong Kong, Taiwan, and Singapore, further expanding access to this novel IDH1 inhibitor for patients in need.-Fineline Info & Tech
