The FDA announced Breakthrough Therapy Designation (BTD) for acalabrutinib (Calquence) as a single agent to treat chronic lymphocytic leukemia (CLL)
Oct. 13, 2016 — TG Therapeutics, Inc. announced that it has filed with the FDA an amended protocol for the GENUINE Phase 3 trial. The original trial design of the GENUINE study consisted of two parts:
- Part I to evaluate the effect of the addition of TG-1101, also known as ublituximab to ibrutinib on overall response rate (ORR) in approximately the first 200 patients enrolled, to support a filing for accelerated approval of TG-1101; and
- Part II to evaluate the effect of the addition of TG-1101 to ibrutinib on progression-free survival (PFS) in all study patients (approximately 330), to support a filing for full approval of TG-1101.
Ublituximab is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes.
The amended protocol contains the following substantive changes:
- Part II of the study has been eliminated, and accordingly, the study’s sole primary endpoint will be ORR as originally contemplated in Part I; and
- Target enrollment has been reduced to approximately 120 randomized patients.
Additionally, patients will be followed until progression, but the study will no longer be powered for PFS.
FDA agrees that Overall Response Rate (ORR) data from revised GENUINE study can be used to request pre-BLA (Biologics License Application) meeting. If results of the revised GENUINE study are positive, the Company plans to file a BLA for accelerated approval based on the outcome of the pre-BLA meeting.
Enrollment expected to be completed before year end 2016 with top-line data available in first half of 2017.
Read more here:
http://ir.tgtherapeutics.com/releaseDetail.cfm?ReleaseID=993364
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