Rhizen Pharmaceuticals receives USFDA approval for Umbralisib

Rhizen Pharmaceuticals (associate company of Alembic Pharmaceuticals) announced that its novel next generation PI3K-delta inhibitor, Umbralisib, which was licensed to TG Therapeutics (NASDAQ: TGTX), has secured US FDA 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

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