FDA granted accelerated approval to umbralisib / HPBCD tablet

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The Food and Drug Administration granted accelerated approval to umbralisib (Ukoniq, TG Therapeutics), a kinase inhibitor including PI3K-delta and casein kinase CK1-epsilon, 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.

The recommended umbralisib dose is 800 mg taken orally once daily with food until disease progression or unacceptable toxicity.

Ukoniq tablets are for oral administration. Each tablet contains 200 mg of umbralisib free base equivalent to 260.2 mg of umbralisib tosylate. The tablets also contain inactive ingredients: croscarmellose sodium, hydroxypropyl betadex, hydroxypropyl cellulose, magnesium stearate and microcrystalline cellulose.

3 comments

  1. Well, it is not public at all, based on enigmatic FDA inactive ingredients database I assume it should be 72 mg based on the dosing regimen of the product, but this is a mere assumption. Not much HPBCD, compared to API dose (which is quite high).

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