ADULT T-CELL LEUKEMIA/LYMPHOMA

Valemetostat New Drug Application Submitted in Japan for Treatment of Patients with Adult T-Cell Leukemia/Lymphoma

Retrieved on: 
Tuesday, December 28, 2021
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Valemetostat previously received Orphan Drug designation (ODD) from the Japan MHLW for treatment of patients with relapsed/refractory ATL.

Key Points: 
  • 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.

Valemetostat Pivotal Data Shows Promising Response Rates in Patients with Adult T-Cell Leukemia/Lymphoma

Retrieved on: 
Saturday, December 11, 2021
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Annual general meeting, DXD, Prognosis, Research, NHL, Safety, Thought, Adult, Progression-free survival, ORR, Peripheral T-cell lymphoma, EZH2, Cancer, ADC, EZH1, ODD, Daiichi Sankyo, Death, Gene, Patient, Quality of life, Cardiovascular disease, PTCL, Enzyme, Laboratory, Pit additive, Program, Sustainable development, ATL, MHLW, Alpha, Lymphatic system, Technology, Vaccine, Pharmaceutical industry, Fine chemical, Wood drying, Silviculture, Mortar (masonry), Online gambling, Adult T-Cell Leukemia/Lymphoma, EZH1 and EZH2, the Phase 2 Study, Valemetostat, Daiichi Sankyo, ADULT T-CELL LEUKEMIA/LYMPHOMA, EZH1 AND EZH2, THE PHASE 2 STUDY, VALEMETOSTAT, DAIICHI SANKYO

Secondary endpoints include investigator-assessed ORR, best response in tumor lesions, complete remission rate, tumor control rate, time to response, duration of response, progression-free survival, overall survival and safety.

Key Points: 
  • Secondary endpoints include investigator-assessed ORR, best response in tumor lesions, complete remission rate, tumor control rate, time to response, duration of response, progression-free survival, overall survival and safety.
  • A total of 25 patients were enrolled in the study in Japan.
  • Valemetostat is a potential first-in-class dual inhibitor of EZH1 and EZH2 currently in clinical development in the Alpha portfolio of Daiichi Sankyo.
  • Valemetostat is an investigational medicine that has not been approved for any indication in any country.