April 15, 2022
Tislelizumab was approved in China as second-line therapy for esophageal squamous cell carcinoma
BeiGene announced that the China National Medical Products Administration (NMPA) approved the anti-PD-1 antibody, tislelizumab, for treating patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC). It is indicated for patients whose disease progressed or are intolerant to first-line standard chemotherapy.
The approval was based on Phase 3 clinical trial, RATIONALE 302, which compared tislelizumab with chemotherapy. The overall survival (OS) was the primary endpoint. The median overall survival was 8.6 months in the tislelizumab arm versus 6.3 months in the chemotherapy arm.
13 April 2022
Vitrakvi was approved in China for NTRK fusion-positive advanced or recurrent solid tumors
Bayer announced that Vitrakvi (larotrectinib) was approved for treating Neurotrophic Tyrosine Receptor Kinase (NTRK) -fusion-positive advanced or recurrent solid tumors in China. Vitrakvi is approved for both adult and pediatric patients.
Bayer announced that Vitrakvi showed a significant response rate and durable response in clinical studies. The approval was based on
Phase 1 trial in adult patients
Phase 2 NAVIGATE trial in adults and adolescents
Phase 1/2 SCOUT trial in pediatrics
Bayer announced that China's National Medicinal Products Administration is evaluating the liquid formulation of Vitrakvi. Vitrakvi was previously approved in the US, Japan, Europe, and the UK.
Astellas announced the approval of Xospata in China
Astellas has announced the approval of Xospata (gilteritinib) for relapsed (a disease that has returned) or refractory (resistant to treatment) acute myeloid leukemia (AML) with an FLT3 mutation by the National Medical Products Administration.
AML, the most common type of leukemia in adults, impact the blood and bone marrow. The incidence of AML in China is expected to be 80,000 people per year. The average duration of survival is less than six months in patients suffering from AML.
The product has been discovered by a collaboration with Kotobuki Pharmaceutical Co., Ltd. Astellas retains the rights to develop, manufacture, and commercialize gilteritinib. The product has already received the approvals from the drug regulatory authorities of the US and Japan in 2018, Europe and Canada in 2019, and Korea, Brazil, and Australia in 2020.
The drug acts by inhibiting LT3- ITD, a type of FLT3mut+, a mutant that is found in one-third of patients suffering from AML.