Rhizen Pharmaceuticals, a clinical-stage oncology-focused biopharma company, announced that its novel next generation PI3K-delta inhibitor, Umbralisib, which was licensed to TG Therapeutics, 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 per cent with 16 per cent complete responses and in FL an ORR of 43 per cent with three per cent 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.

The company expects final approval in the later half of this year, it informed in an interaction with the media.

Umbralisib is a novel, next generation, oral, once daily, inhibitor of phosphoinositide 3 kinase (PI3K) delta and casein kinase 1 (CK1) epsilon and was discovered by Rhizen Pharma and subsequently licensed to TG Therapeutics 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 commercialisation rights for India while also being the manufacturing and supply partner for Umbralisib.

Swaroop Vakkalanka, President & CEO of Rhizen Pharmaceuticals said, “We are keen to bring Umbralisib to Indian patients and we plan to initiate activities towards registration and approval there soon.”

In a conference call with the media, the companies disclosed that around eight to nine months would be required before the drug gets launched in the Indian market, subject to regulatory approvals.

Pranav Amin, Chairman, Rhizen Pharmaceuticals & MD of Alembic Pharmaceuticals said, “We are extremely proud of this historic milestone for Rhizen, and of the fact that Umbralisib is the first NCE discovered by Indian scientists to secure a US FDA approval. We are committed to working together with TG Therapeutics and Rhizen Pharma to ensure uninterrupted supply of UKONIQ.”