The Food and Drug Administration (FDA) has approved Ruxience (rituximab-pvvr; Pfizer), a biosimilar to Rituxan (Genentech and Biogen), for the treatment of adult patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and granulomatosis with polyangitis and microscopic polyangiitis. The approval was based on a comprehensive data package which included results from the REFLECTIONS B3281006 study in…
Results of the study showed that the rate of symptomatic recurrent VTE – the primary end point – was similar in both treatment groups with 1.2% of patients experiencing a recurrent event in the rivaroxaban group compared with 3.0% in the standard anticoagulation group.
The FDA has approved Venclexta in combination with Gazyva for the treatment of patients with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.
The FDA has expanded the indication for Tibsovo to include treatment of newly diagnosed acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.
