The FDA granted orphan drug designation to umbralisib based on results from the phase IIb UNITY-NHL trial cohort of patients with follicular lymphoma who have received at least 2 prior lines of therapy, including an anti-CD20 monoclonal antibody and an alkylating agent.
The submission was primarily based on updated phase II efficacy and safety data for tazemetostat for patients with relapsed or refractory follicular lymphoma who have received at least 2 prior lines of systemic therapy.
The study is evaluating the oral inhibitor for patients with relapsed or refractory follicular lymphoma.
Idelalisib May Induce More Favorable Outcomes in Clinical Trial Participants, Versus Medicare Beneficiaries
Medicare beneficiaries saw unfavorable results when compared to clinical trial participants being treated with idelalisib for their follicular lymphoma or chronic lymphocytic leukemia.
This research could potentially pave the way for possible immunotherapy approaches for common forms of non-Hodgkin lymphoma.
The study evaluating itacitinib in combination with corticosteroids in patients with treatment-naïve acute graft-versus-host disease did not produce statistically significant results.
Treatment with lenalidomide and rituximab improved progression-free survival, compared with placebo in patients ≥70 years old with indolent non-Hodgkin lymphoma.
The combination use of polatuzumab-vedotin, obinutuzumab, and lenalidomide showed high complete response rates in patients with relapsed/refractory follicular lymphoma.
Mosunetuzumab generated durable responses in patients with highly refractory non-Hodgkin lymphomas.
Biosimilars have shown to be cost-effective treatments in oncology and hematology, according to Jacopo Giuliani, MD.