On 30th March 2017, the Japanese Ministry of Health, Labor and Welfare (MHLW) approved MUNDESINE® (forodesine hydrochloride) for the treatment of Relapsed or Refractory (R/R) Peripheral T-Cell Lymphoma (PTCL).
Mundipharma’s MUNDESINE® is an orally administered Purine Nucleoside Phosphorylase (PNP) inhibitor, and this approval is the first in the world for this type of agent. PNP inhibition results in increased levels of 2'-deoxyguanosine and buildup of intracellular deoxyguanosine 5'-triphosphate, initiating apoptosis.2
The compound is the first oral monotherapy for this indication and also holds Orphan Drug status in Japan. The approval is based on successful clinical trials.
- Mundipharma’s mundesine approved in Japan. 2017 Apr 03. https://www.biocentury.com/bc-extra/company-news/2017-04-03/mundipharmas-mundesine-approved-japan. [Accessed 2017 Apr 06].
- Furman R.R. & Hoelzer D. Purine nucleoside phosphorylase inhibition as a novel therapeutic approach for B-cell lymphoid malignancies. Seminars in Oncology. 2007 Dec; 34(6 Suppl 5):S29–34.