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FDA Greenlights New Rituxan Biosimilar

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…

Tibsovo Approved to Treat Newly Diagnosed AML With IDH1 Mutation

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.
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