Rhizen Pharma gets USFDA accelerated nod for Partnered asset Umbralisib adult patients with Relapsed or Refractory MZL & FL
Basel, Switzerland: Rhizen Pharmaceuticals, a clinical-stage oncology-focused biopharmaceutical company, has recently announced that the company's novel next generation PI3K-delta inhibitor, Umbralisib, which was licensed to TG Therapeutics, has secured USFDA accelerated approval for the treatment of:
adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen, and
adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy.
Accelerated approval was granted for these indications, under a priority review (MZL), based on the results of the Phase 2 UNITY-NHL Trial (NCT02793583); in MZL, an ORR of 49% with 16% complete responses and in FL an ORR of 43% with 3% complete responses were achieved, respectively. Umbralisib was earlier granted Breakthrough Therapy Designation (BTD) for the treatment of MZL and orphan drug designation (ODD) for the treatment of MZL and FL.
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