Investigators are assessing tirabrutinib, which received orphan drug designation from the FDA, as a treatment for patients with relapsed or refractory primary central nervous system lymphoma in the phase 2 PROSPECT study.
A qualitative, interview-based analysis identified 7 distinct roles played by hematologists relating to shared decision making for patients with advanced lymphoma or leukemia.
The FDA states that the refusal to file letter for SGX301 in early-stage cutaneous T-cell lymphoma was because the new drug application was insufficient for permit substantive review.