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
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.
Umbralisib is a novel, next generation, oral, once daily, inhibitor of phosphoinositide 3 kinase (PI3K)
delta and casein kinase 1 (CK1) epsilon and and was discovered by Rhizen Pharma and subsequently
licensed to TG Therapeutics (NASDAQ: TGTX) at an IND stage (TGR 1202) in 2012. In 2014, both parties
entered into a licensing agreement as a part of which TGTX obtained worldwide rights and Rhizen has
retained commercialization rights for India while also being the manufacturing and supply partner for
Umbralisib.
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