Takeda’s Pevonedistat Receives the US FDA’s Breakthrough Therapy Designation to Treat Patients with Higher-Risk Myelodysplastic Syndrome

July 31, 2020 Auto Bot Breakthrough Therapy Designation, FDA, Latest, patients, Pharma, receives, Takeda 0

Shots:

  • The BT designation is based on the final analysis of the Pevonedistat-2001 P-II study assessing pevonedistat + azacitidine vs azacitidine as monothx. in patients with rare leukemias, including HR-MDS
  • The 1EPs of the study include OS, EFS, CR and transfusion independence, and AE profile. The designation addresses the needs of people living with HR-MDS, for whom few therapies exist, and the benefits are limited
  • Pevonedistat is a first in class NEDD8-activating enzyme (NAE) inhibitor. The pre-clinical studies demonstrated the inhibition of NAE, blocked the modification of select proteins, which resulted in the disruption of cell cycle progression and cell survival, leading to cancer cell death

Click here ­to­ read full press release/ article | Ref: Takeda | Image: Future Medicine India