The FDA Extends TG Therapeutics Inc.’s (NASDAQ: TGTX) PDUFA Target Date For sNDA for Ublitiuximab Combination with UKONIQ

TG Therapeutics Inc. (NASDAQ: TGTX) has announced that the US FDA has extended its PDUFA target date to June 25, 2022, for the supplemental New Drug Application and Biologics License Application for ublituximavb as a treatment combination with UKONIQ for patients with small lymphocytic lymphoma and chronic lymphocytic leukemia.

Revised survival rates analyses represented material change on submission 

The FDA advised the corporation that the revised survival rates analyses, presented to the agency in February 2022, represented a material change to the submissions. The PDUFA date will be extended to allow time for a comprehensive evaluation of the submissions.

CEO and Chairman Michael S. Weiss stated, “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. We continue to believe in the potential of U2 to provide a meaningful treatment option to patients with CLL and SLL.”

The Oncologic Drugs Advisory Committee (ODAC) examines and assesses findings on the efficacy and safety of commercial and experimental human medicinal products for the treatment of cancer and makes suggestions to the Commissioner of Food and Drugs. Even though the ODAC Committee’s suggestion will be taken into account by the FDA, the agency makes the final decision on marketing authorization.

Risk-benefit analysis among ODAC questions and discussion topics

The FDA has informed TG Therapeutics that prospective ODAC inquiries and discussion issues include the risk-benefit of the U2 mixture in the treatment of CLL or SLL and the benefit-risk of UKONIQ in refractory/relapsed marginal zone lymphoma or follicular lymphoma. In addition, the general safety profile of the U2 combination, including adverse events, discontinuations related to unfavorable events, and dose adjustments, is expected to be examined as a component of the risk-benefit- analysis. The FDA’s worry, which prompted the ODAC meeting, appears to be based on a preliminary examination of overall survival data from the UNITY-CLL trial.