FDA pushes back a review date for TG's 'U2' combo as the biotech steels itself for upcoming adcomm
The FDA has pushed back its review of TG Therapeutics’ U2 combo (ublituximab plus Ukoniq) in patients with chronic lymphocytic leukemia and small lymphocytic lymphoma after the drugmaker submitted updated survival data in February the agency deemed a major amendment to its application, according to a release.
The agency set a new review date of June 25, TG said.
The news wasn’t unexpected given some of TG’s recent comments. In a statement, CEO Michael Weiss had this to say:
As mentioned on our earnings call earlier this week, we believed an extension of the PDUFA date was a likely scenario especially given the proposed timing of the upcoming ODAC meeting. We hope this extension provides the time needed to give proper attention and review to the U2 BLA/sNDA.
With its review date pushed out, TG is now staring directly at an upcoming adcomm for U2’s application here, which the FDA called back in November. The agency at the time indicated to the biotech that it had more questions on the OS endpoint and safety data in the pivotal Phase III study undergirding its application.
In an update Thursday, TG said the FDA had sent a list of potential questions for that adcomm, for which a date still hasn’t been scheduled. Here’s what the company said could be on the docket:
The FDA has notified the Company that potential questions and discussion topics for the ODAC include: the benefit-risk of the U2 combination in the treatment of CLL or SLL, and the benefit-risk of Ukoniq in relapsed/refractory marginal zone lymphoma (MZL) or follicular lymphoma (FL). In addition, as part of the benefit-risk analysis, the overall safety profile of the U2 regimen, including adverse events (serious and Grade 3-4), discontinuations due to adverse events, and dose modifications, is expected to be reviewed. 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.