A Review on FDA Approval of Lymphoma Drug Ukoniq (Umbralisib) And Its Withdrwal Due to Safety Concerns

Abstract

Present study focuses on Ukoniq also known as Umbralisib. The drug approved in June 2020 for treatment of 2 types of lymphoma cancerMZL & FL. Later on, FDA withdrawn this specific drug approval for umbralisib (Ukoniq), an oral inhibitor of PI3K-δ and CK1-ε which is manufactured by TG Therapeutics. The agency began investigating the drug in February 2022 after findings from the phase 3 UNITYCLL trial (NCT026112311) suggested that umbralisib might be associated with an increased risk of death. There are many drugs that have been withdrawn from the market because of ADR’s. Trends and Reasons for withdrawal of Umbralisib was identified by FDA & has been withdrawn from the market, and communicated as well.