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Association details:
| Biomarker: | No biomarker |
|---|---|
| Cancer: | Chronic Lymphocytic Leukemia |
| Drug: | Ukoniq (umbralisib) (PI3Kδ inhibitor, Casein kinase I epsilon inhibitor) + Briumvi (ublituximab-xiiy) (CD20 inhibitor) |
| Direction: | Sensitive |
Evidence:
Title:
TG Therapeutics Announces Fast Track Designation Granted by the FDA to Ublituximab in Combination with Umbralisib for the Treatment of Adult Patients with Chronic Lymphocytic Leukemia
Published date:
10/21/2020
Excerpt:
TG Therapeutics, Inc....today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the combination of ublituximab...and umbralisib...for the treatment of adult patients with chronic lymphocytic leukemia (CLL).
Title:
TG Therapeutics Announces Positive Topline Results from the UNITY-CLL Phase 3 Study Evaluating the Combination of Umbralisib and Ublituximab (U2) for the Treatment of Patients with Chronic Lymphocytic Leukemia
Published date:
05/05/2020
Excerpt:
...UNITY-CLL Phase 3 trial evaluating the combination of umbralisib plus ublituximab (U2) compared to obinutuzumab plus chlorambucil in patients with previously untreated and relapsed/refractory chronic lymphocytic leukemia (CLL). The trial met its primary endpoint at a prespecified interim analysis demonstrating a statistically significant improvement in progression-free survival (PFS) (p<.0001)...
Trial ID:
