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Rhizen Pharmaceuticals AG, a clinical-stage, oncology-focused biopharma company, with 50% stake owned by Alembic Pharmaceuticals and the rest by its Indian CEO Swaroop Vakkalanka, has announced that its novel, next generation PI3K-delta inhibitor Umbralisib (Ukoniq) has secured U.S. FDA accelerated approval for the treatment of blood cancer.
The drug, which has been licensed to TG Therapeutics since 2012, has bagged the approval for the U.S. market. TG Therapeutics has the global license except for the Indian market which will be handled by Rhizen and Alembic.
The drug is for treatment is 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 per cent with 16 per cent complete responses and in FL an ORR of 43 per cent with 3 per cent complete responses were achieved, respectively
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