- TG Therapeutics Inc's TGTX new data showed that ublituximab /Ukoniq, dubbed U2, had an elevated risk of death in the phase 3 Unity combo trial or chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL)
- The data analyzed at the request of the FDA showed that overall survival favored the control arm rather than the treatment arm.
- Hence, TGTX is pulling Ukoniq (umbralisib) off the market for the two indications and withdrawing an approval request for the combo med.
- Related: FDA Pushes TG Therapeutics' Ublituximab / Ukoniq Combo Therapy Applications In Blood Cancer Settings.
- As part of the ongoing review, the FDA requested an early analysis of OS from the UNITY-CLL trial. In the first analysis of OS using a cut-off date of September 2021, there was an imbalance in favor of the control arm (HR: 1.23).
- However, approximately 15% of patients had missing or outdated survival data. Further, when excluding deaths related to COVID-19, the two arms were about balanced (HR: 1.04).
- In February, the company submitted updated OS data with the same September 2021 cut-off date but reduced missing data and additional OS events, which improved from the previously reported OS data.
- Neither the original preliminary OS results nor the updated preliminary OS results were statistically significant.
- In February, the FDA alerted a possible elevated risk of death from the drug, which won accelerated approval a year earlier in 2021 as a monotherapy to treat two types of lymphoma.
- The Oncologic Drug Advisory Committee (ODAC) meeting scheduled for 22 April will be canceled.
- Price Action: TGTX shares closed 8.48% lower at $8.85 on Thursday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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