- The FDA has extended the review period of TG Therapeutics Inc's (NASDAQ: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.
