Umbralisib, sold under the brand name Ukoniq, was an anti-cancer medication formulated as oral tablets. It is a kinase inhibitor that acts on phosphoinositide 3-kinase delta and casein kinase CK1-epsilon. It was originally indicated for adults with relapsed or refractory marginal zone lymphoma and follicular lymphoma who had already received prior systemic therapies. It was granted accelerated approval for medical use in the United States in February 2021, then withdrawn from the United States market in June 2022 after clinical trials identified an increased mortality risk, and it is no longer available in that market.
Facts
Classification
Approval Status ATC ClassSourced to the subject's own accountL: Antineoplastic and Immunomodulating Agents 2 Route of Administration Approved UseTreatment of marginal zone lymphoma (MZL) and follicular lymphoma (FL) 4 First Approved / Isolated Year Significant RiskPossible increased risk of death 4 Connections
Sources
1. Umbralisib (Wikipedia)
lead sentence 6
However, due to concerns for increased long term side effects leading to inferior overall survival which led to increased FDA scrutiny in the form of an ODAC review, it has been withdrawn from the US market.
https://en.wikipedia.org/wiki/Umbralisib, lead section
ne lymphoma (MZL) and follicular lymphoma (FL). It is taken by mouth.
View the Source2. Anatomical Therapeutic Chemical Classification System (Wikipedia)
WikipediaFirst-level anatomical group codes, Code LQuote, First-level anatomical group codes, Code L
Antineoplastic and immunomodulating agents
3. Wikipedia
Wikipedia contributors, Wikimedia Foundation- Route of Administration: Oral
4. FDA Drug Safety Communication: Ukoniq (umbralisib) withdrawn due to safety concerns
Statement, approved uses
Ukoniq was approved to treat two specific types of lymphoma: marginal zone lymphoma (MZL) and follicular lymphoma (FL).
Statement, safety finding
continued to show a possible increased risk of death in patients receiving Ukoniq.
View the Source5. Drugs.com: Ukoniq (umbralisib) FDA Approval History
FDA Approval HistoryQuote, FDA Approval History
Ukoniq (umbralisib) was first approved by the FDA on February 5, 2021
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