Solasia expects approval of DARINAPARSIN soon, a drug for Peripheral T-Cell Lymphoma
Designated as an Orphan Drug in the US and EU for Peripheral T-Cell Lymphoma
New Drug Application filed in Japan
Regulatory approval expected in 2022
On June 30, 2021, Solasia Pharma K.K.announced the submission of a New Drug Application (NDA) for DARINAPARSIN, its new anti-cancer drug (development code: SP-02). Solasia is one of the specialty pharmaceutical companies based in Asia. Earlier, the firm confirmed the positive results of Darinaparsin in Pivotal Phase 2 Study for the treatment of Peripheral T-Cell Lymphoma.
As of now, there is no standard drug for the treatment of relapsed or refractory Peripheral T-Cell Lymphoma. However, the novel mechanism of action and no safety concerns relating to the administration of Darinaparsin can be preferred over already approved drugs in the future.
If approved and launched, Darinaparsin would be the third milestone achieved by Solasia i.e. the third drug successfully developed, launched, and bought in the market to treat Peripheral T-Cell Lymphoma.
About Darinaparsin (SP-02)
Darinaparsin is a small-molecule organoarsenic compound with antitumor activity and a novel mechanism of action. It is a mitochondrial targeting drug developed for solid and hematological cancers. The compound is believed to induce cell cycle arrest and apoptosis (cell death). The final registration trial or Pivotal Phase 2 Study for the indication of relapsed or refractory Peripheral T-Cell Lymphoma showed positive results with evidence of antitumor effect and no safety concerns in the analysis.