The US Food and Drug Administration (FDA) has approved the design of a global phase 3 trial for linperlisib for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) who have received at least one prior systemic therapy.
This clearance, announced on April 2, 2025, follows a successful end-of-phase 2 meeting with the FDA, according to Yingli Pharma, the manufacturer of the drug.
Linperlisib is an oral therapy targeting patients with PTCL, according to the press release. The phase 3 study, set to begin in the second quarter of 2025, will compare linperlisib against a physician’s choice of standard care treatments to assess its efficacy and safety.
The trial builds on earlier studies showing linperlisib’s potential in PTCL and other hematologic malignancies, according to the company.
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