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 (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.

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