Suzhou, China - The partner of CStone Pharmaceuticals ('CStone', HKEX: 2616), Servier, announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for TIBSOVO (ivosidenib tablets) as a potential treatment for patients with previously untreated IDH1-mutated acute myeloid leukemia (AML). The sNDA was granted Priority Review, which accelerates the review and shortens the review time goal from 10 months to 6 months. Priority Review is typically given to drugs that may offer major advances in treatment or may provide a treatment where no adequate therapy exists. CStone is pursuing submission for this indication in China as well.

Meanwhile, Servier announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for TIBSOVO for two indications as a first line treatment, in combination with azacitidine, in patients with previously untreated IDH1-mutated acute myeloid leukemia (AML) and not eligible for intensive chemotherapy, as well as in previously treated, locally advanced or metastatic IDH1-mutated cholangiocarcinoma. TIBSOVO is the first IDH1 mutation specific targeted therapy to be submitted for registration in Europe.

Dr. Jason Yang, Chief Medical Officer of CStone, said, 'We are very pleased to see these significant milestones in multiple indications for TIBSOVO in the U.S. and Europe. TIBSOVO is the first therapy targeting cancer metabolism to demonstrate improved event-free survival and overall survival in combination with azacitidine in patients with previously untreated IDH1-mutated AML. We will work closely with the National Medical Products Administration (NMPA) of China with an aim to bring this innovative therapy to more Chinese patients as soon as possible.'

The sNDA acceptance and the MAA submission are supported by results from the AGILE study, a global, Phase 3 trial in patients with previously untreated IDH1-mutated AML, which were presented at the 2021 American Society of Hematology Annual Meeting and Exposition. The data demonstrated that treatment with TIBSOVO in combination with azacitidine significantly improved event-free survival (EFS) (hazard ratio [HR] = 0.33, [95% CI: 0.16, 0.69], 1-sided P = 0.0011) 1,2. In addition, the combination of TIBSOVO with azacitidine showed a statistically significant improvement in overall survival (OS) (HR = 0.44, [95% CI : 0.27, 0.73], 1-sided P = 0.0005), with a median OS of 24.0 months.

On July 19, 2019, CStone announced that the first patient in China was dosed in AGILE, the global registrational Phase 3 study of TIBSOVO. 16 centers in China participated in this global study.

The MAA submission for cholangiocarcinoma is supported by data from the ClarIDHy study, the first and only randomized Phase 3 trial for previously treated IDH1-mutated cholangiocarcinoma. Results from the ClarIDHy study demonstrated a statistically significant improvement in the primary endpoint of progression-free survival (PFS) (hazard ratio [HR] =0.37, [95% CI: 0.25, 0.54], p

(C) 2022 Electronic News Publishing, source ENP Newswire