Valemetostat New Drug Application Submitted in Japan for Treatment of Patients with Adult T-Cell Leukemia/Lymphoma
Valemetostat previously received Orphan Drug designation (ODD) from the Japan MHLW for treatment of patients with relapsed/refractory ATL.
- Valemetostat previously received Orphan Drug designation (ODD) from the Japan MHLW for treatment of patients with relapsed/refractory ATL.
- Valemetostat is the fifth innovative oncology medicine from our pipeline to be submitted for regulatory approval in Japan in the past three years.
- Valemetostat received ODD from the U.S. Food & Drug Administration for the treatment of PTCL in December 2021, ODD from the Japan MHLW for the treatment of relapsed/refractory ATL in November 2021 and SAKIGAKE Designation from the Japan MHLW for the treatment of adult patients with relapsed/refractory PTCL in April 2019.
- A total of 25 patients were enrolled in the study in Japan.