Name: Tirabrutinib in Primary central nervous system lymphoma: Phase of product development
Published: 2026-09-14T15:39:06-04:00

Product information and disease description Product description

Phase of product development

6 evidence topics · 5 sources

FDA orphan designation and approval status

“Date Designated: 03/21/2023” (opens the source at this quote in a new tab)
“Orphan Designation: Treatment of primary central nervous system lymphoma” (opens the source at this quote in a new tab)
“FDA Orphan Approval Status: Not FDA Approved for Orphan Indication” (opens the source at this quote in a new tab)

New drug application and FDA action date

“accepted for filing” (opens the source at this quote in a new tab)
“under the accelerated approval pathway” (opens the source at this quote in a new tab)
“PDUFA Date of December 18, 2026” (opens the source at this quote in a new tab)

Regulatory submission: NDA submitted December 2025

“As for VELEXBRU, as President Takino mentioned earlier, we filed an application in the US last December, and the application was accepted in February of this year.” (opens the source at this quote in a new tab)

Launch: Anticipated in the fiscal year ending March 2027

“Next, I will discuss the full-year forecast for the fiscal year ending March 31, 2027.” (opens the source at this quote in a new tab)
“One of these, tirabrutinib, ONO-4059, is currently under review for approval by the US FDA. We are looking forward to this being our third global product as we prepare for its launch this fiscal year.” (opens the source at this quote in a new tab)

Approval dates outside the United States

“In Japan, tirabrutinib was approved in March 2020” (opens the source at this quote in a new tab)
“in South Korea in November 2021 and in Taiwan in February 2022.” (opens the source at this quote in a new tab)

Taiwan assessment report: recorded approval date

“2021/10/29” (opens the source at this quote in a new tab)