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Darinaparsin: First Approval.
1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.
Drugs
|November 4, 2022
Summary
Darinaparsin, a novel anticancer drug targeting mitochondria, has gained approval in Japan for relapsed or refractory peripheral T-cell lymphoma (PTCL). Further clinical development is planned globally for this organoarsenic therapy.
Area of Science:
- Oncology
- Pharmacology
- Drug Development
Background:
- Peripheral T-cell lymphoma (PTCL) is an aggressive non-Hodgkin lymphoma with limited treatment options.
- Darinaparsin is a novel, mitochondrially-targeted organoarsenic anticancer agent.
- Solasia Pharma K.K. is developing darinaparsin for PTCL treatment.
Purpose of the Study:
- To summarize the key milestones in the development of darinaparsin.
- To highlight the regulatory approval of intravenous darinaparsin for relapsed or refractory PTCL in Japan.
Main Methods:
- Review of clinical development program milestones.
- Summary of regulatory submission and approval process in Japan.
Main Results:
- Darinaparsin (Darvias®) received approval in Japan for relapsed or refractory PTCL.
- Intravenous formulation facilitates clinical application.
Conclusions:
- Darinaparsin represents a significant advancement in PTCL treatment.
- Global clinical development is progressing, with planned trials in China, the USA, and the EU.
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