publication date: Feb. 12, 2021

Drugs & Targets

Ukoniq receives FDA accelerated approval for marginal zone lymphoma and follicular lymphoma

FDA has granted accelerated approval to Ukoniq (umbralisib), 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.

Approval was based on two single-arm cohorts of an open-label, multi-center, multi-cohort trial, UTX-TGR-205 (NCT02793583), in 69 patients with MZL who received at least one prior therapy, including an anti-CD20 containing regimen, and in 117 patients with FL after at least 2 prior systemic therapies. Patients received umbralisib 800 mg orally once daily until disease progression or unacceptable toxicity.

Ukoniq is sponsored by TG Therapeutics.

Efficacy was based on overall response rate and duration of response using modified 2007 International Working Group criteria assessed by an independent review committee.

For patients with MZL, the ORR was 49% (95% CI: 37.0, 61.6) with 16% achieving  complete responses. Median DOR was not reached (95% CI: 9.3, NE) in these patients. For patients with FL, the ORR was 43% (95% CI: 33.6, 52.2) with 3% achieving  complete responses. Median DOR was 11.1 months (8.3, 16.4).

 

Breyanzi receives FDA approval for adults with relapsed or refractory large-B-cell lymphoma

FDA has approved Breyanzi (lisocabtagene maraleucel), a cell-based gene therapy to treat adult patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least two other types of systemic treatment. 

Breyanzi is … Continue reading Ukoniq receives FDA accelerated approval for marginal zone lymphoma and follicular lymphoma

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