MODERATE IMPACT – Servier has resubmitted an MAA to the EMA for its IDH1 inhibitor Tibsovo (ivosidenib) for use with azacitidine as a first-line treatment for patients with IDH1-mutated AML who are not eligible for intensive chemotherapy, and for treating previously treated, locally advanced or metastatic IDH1-mutated cholangiocarcinoma.
Servier has resubmitted the marketing application to the EMA more than a year after a previous EU filing was withdrawn for the product, after the EMA had expressed concern that the main study did not provide enough evidence that Tibsovo was effective. Tibsovo is approved in the US for treating AML and cholangiocarcinoma. Tibsovo is also approved for use in China for relapsed or refractory AML.
Source: Server Press Release