FDA drug approvals in hematologic malignancies throughout 2018 have changed the treatment paradigm of multiple diseases and resulted in necessary updates to treatment guidelines and best practices. Here we preview some of the recent approvals and practice-changing data that will be covered at this year’s International Congress on Hematologic Malignancies®: Focus on Leukemias, Lymphomas, and Myeloma.
It’s not every year that we we cover or even make ground in Waldenström macroglobulinemia. But this rare form of B-cell lymphoma, characterized by lymphoplasmacytic cells infiltrating the bone marrow, saw the FDA approval of ibrutinib plus rituximab in 2018, expanding the indication for ibrutinib in this disease.
This approval was based on new data from the phase III iNNOVATE trial, in which 150 patients with untreated or relapsed/refractory disease were randomized to receive either ibrutinib or placebo, in combination with rituximab. The 30-month progression-free survival (PFS) was significantly higher for the patients in the ibrutinib arm compared with placebo: 82% vs 28%, respectively. Patients receiving the combination had an 80% lower risk of disease progression or death.