Topic: chronic lymphocytic leukemia
Phase 2b data showed TG Therapeutics’ umbralisib partially shrank tumors in 33% and eradicated them in 19% of marginal zone lymphoma patients.
A data safety monitoring board has recommended the continuation of TG Therapeutics’ phase 3 chronic lymphocytic leukemia trial.
Previously jilted by Infinity Pharmaceuticals and AbbVie, Copiktra has seen a rough road to its approval as the first dual inhibitor of PI3K-delta and PI3K-gamma.
A phase 3 trial of Celgene’s luspatercept in beta-thalassemia has hit its primary goal, teeing it up for an FDA filing in the first half of next year.
The biotech changed its plans because its phase 3 overall response rate data “were not sufficiently mature to conduct the analysis.”
Fred Hutchinson scientists have identified biomarkers associated with dangerous side effects possible in cancer patients treated with CAR-T cells.
Wednesday's shot of your news of note.
TG Therapeutics’ experimental med ublituximab used alongside AbbVie’s marketed Imbruvica (ibrutinib) has hit its primary endpoint in a phase 3 study in chronic lymphocytic leukemia (CLL) patients, as the company eyes an accelerated FDA approval later this year.
Venclexta’s road to market was a speedy one, notching three breakthrough drug designations, orphan drug designation and priority review status before nabbing an accelerated approval in April.
TG Therapeutics got orphan drug designation from the FDA for both its clinical candidates this week.