By VETTAPHARMA reporter: Waltham, Mass. & Osaka, Japan — February 17, 2026 — Deciphera Pharmaceuticals, a member of Ono Pharmaceutical Co., Ltd., announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for tirabrutinib under the accelerated approval pathway for the treatment of relapsed or refractory primary central nervous system lymphoma (R/R PCNSL). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of December 18, 2026, marking a key regulatory milestone toward potential approval and commercialization.
The NDA submission for tirabrutinib is supported by positive Phase 2 PROSPECT study results, where the drug demonstrated a 67% overall response rate (ORR) and a 44% complete response rate, with a manageable safety profile in patients with R/R PCNSL. If approved, tirabrutinib would become the first BTK inhibitor therapy available in the United States for this rare and aggressive form of non-Hodgkin lymphoma and only the third commercial therapy in the U.S. from the Ono group’s oncology portfolio.
Executive Perspectives
Deciphera’s Chief Medical Officer, Matthew L. Sherman, M.D., stated that R/R PCNSL has historically had poor clinical outcomes and significant unmet medical needs, and noted that FDA acceptance of the tirabrutinib NDA is an important milestone in advancing potential therapy options for patients. Meanwhile, Toichi Takino, President and COO of Ono Pharmaceutical, emphasized the company’s commitment to delivering innovative medicines to benefit patients worldwide.
Clinical and Regulatory Context
Tirabrutinib was discovered and developed by Ono Pharmaceutical Co., Ltd., and is a second-generation Bruton tyrosine kinase (BTK) inhibitor designed to target B-cell malignancies. In addition to its development in the U.S., tirabrutinib has prior approvals in Japan, South Korea and Taiwan for certain hematologic conditions, reflecting a growing global clinical footprint.
Deciphera continues to pursue development of tirabrutinib through an ongoing Phase 3 randomized trial (ClinicalTrials.gov NCT07104032), which will serve as a confirmatory study for the accelerated approval indication.
Source credit:
- Deciphera Pharmaceuticals. (2026, February 17). Deciphera Pharmaceuticals Announces U.S. Food and Drug Administration Acceptance for Filing of New Drug Application for Tirabrutinib in Patients With Relapsed or Refractory PCNSL. Deciphera. Click here
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