FDA grants accelerated approval to umbralisib

8 February 2021

On Friday, the US Food and Drug Administration granted accelerated approval for Ukoniq (umbralisib), a kinase inhibitor including PI3K-delta and casein kinase CK1-epsilon, developed by US biotech TG Therapeutics (Nasdaq: TGTX), whose shares shot up 11.9% by close of trading and a further 4% to $56.50 in after-hours trading.

The approval is for the following indications:

Adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen;
Adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy.

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