TG THERAPEUTICS, INC. By Chris Wack
TG Therapeutics Inc. shares were down 35%, to $15.07, in premarket trading after the company said the U.S. Food and Drug Administration notified it that it plans to host a meeting of the Oncologic Drugs Advisory Committee.
The company said the meeting is in connection with the FDA's review of the pending Biologics License Application/supplemental New Drug Application for the combination of ublituximab and Ukoniq umbralisib U2 combination for the treatment of adult patients with chronic lymphocytic leukemia and small lymphocytic lymphoma.
The Oncologic Drugs Advisory Committee generally reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer and makes appropriate recommendations to the Commissioner of Food and Drugs. Although the FDA will consider the recommendation of the ODAC committee, the final decision regarding the approval of a product is made solely by the FDA.
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 or follicular lymphoma. The overall safety profile of the U2 regimen, including adverse events, is expected to be reviewed.
The company said the FDA's concern giving rise to the ODAC meeting appears to stem from an early analysis of overall survival from the trial.
The date of the ODAC meeting hasn't yet been determined, although the FDA has stated that it is targeting holding the ODAC in March or April 2022. Given this timing, the company said it believes it is unlikely that the FDA will make a decision on the BLA/sNDA by the PDUFA goal date of March 25, 2022.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
11-30-21 0918ET
