The U.S. Food and Drug Administration (FDA) extended the review date of TG Therapeutics' (TGTX -5.3%) applications seeking approval of ublituximab plus UKONIQ (umbralisib) to treat patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) to June 25.
The FDA notified the company that the updated overall survival analyses which were submitted to the U.S. regulator in February 2022, is a major amendment to the applications, and the FDA needed more time for full review of the submissions.
The FDA's Oncologic Drugs Advisory Committee is expected to meet in March or April to evaluate data related to the drug.
The company noted that the FDA's concern giving rise to the ODAC meeting appears to stem from an early analysis of overall survival from the UNITY-CLL trial.
The company said overall survival was designated as a secondary efficacy outcome in the UNITY-CLL protocol but was not part of the primary analysis and therefore, was not analyzed or included in the Biologics License Application (BLA) and supplemental New Drug Application ((sNDA)). And the study was not powered for overall survival.
The company added that as part of the ongoing review of the BLA/sNDA, the FDA requested an early analysis of overall survival from the UNITY-CLL trial and as of September 2021, there was an imbalance in favor of the control arm
However, when excluding deaths related to COVID-19, the two arms were nearly balanced.
In February 2022, the company submitted updated overall survival data with the same September 2021 cut-off date.