Latest advisory on umbralisib

Umbralisib(umbralisib) was granted accelerated approval for medical use in the United States in February 2021. This has led to increased scrutiny by the U.S. Food and Drug Administration in the form of an ODAC review due to concerns about long-term side effects and increased overall survival. In 4 of 2022, TG Therapeutics announced a voluntary discontinuation of sales of Ukoniq (umbralisib) as it has been approved to treat marginal zone lymphoma and follicular lymphoma. Additionally, the company withdrew its pending Biologics License Application (BLA) and Supplemental New Drug Application (sNDA) for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL) ), which combines umbralisib and ublituximab, the so-called "U2" regimen. The decision was based on overall survival data from the Phase III trial of Unity-CLL (OS), which showed an increasing imbalance in OS. If you want to get more high-quality information, you can contact Yaode, and Yaode will do its best to learn more about high-quality overseas drugs for you.