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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.
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
Rhizen s cancer drug Umbralisib gets USFDA nod: Alembic Pharma
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Last Updated: Feb 09, 2021, 12:33 PM IST
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Synopsis
Alembic Pharma on Tuesday said its associate company Rhizen Pharmaceuticals AG s product Umbralisib, which was licensed to TG Therapeutics, has received approval from the US health regulator the drug for the treatment of certain forms of cancer.
Alembic Pharma on Tuesday said its associate company Rhizen Pharmaceuticals AG s product Umbralisib, which was licensed to TG Therapeutics, has received approval from the US health regulator the drug for the treatment of certain forms of cancer.
In a regulatory filing, Alembic Pharma said Rhizen Pharmaceuticals Umbralisib, which was licensed to TG Therapeutics has secured the United States Food and Drug Administration (USFDA) accelerated approval for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) and Follicular Lymphoma (FL).
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