FDA Pushes TG Therapeutics' Ublituximab / Ukoniq Combo Therapy Applications In Blood Cancer Settings

The FDA has extended the review period of TG Therapeutics Inc's TGTX biologics license application and supplemental New Drug Application for ublituximab in combination with Ukoniq (umbralisib) for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
The Prescription Drug User Fee Act (PDUFA) goal date is postponed to June 25.
The FDA notified the Company that the updated overall survival analyses submitted in February 2022 constituted a significant amendment to the applications.
The FDA's concern giving rise to the Oncologic Drugs Advisory Committee (ODAC) meeting appears to stem from an early analysis of overall survival from the UNITY-CLL trial.
Related: TG Therapeutics Falls 30% As CEO Discloses Partial Clinical Hold On Blood Cancer Trials.
Overall survival was designated as a secondary efficacy outcome in the UNITY-CLL protocol but was not part of the primary analysis.
Additionally, the study was not powered for overall survival.
The FDA requested an early analysis of overall survival from the UNITY-CLL trial.
The FDA is targeting holding the ODAC in March or April 2022.
Price Action: TGTX shares are down 5.71% at $9.74 during the market session on the last check Thursday.