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The FDA has accepted and granted priority review to the new drug application for quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, for the treatment of newly diagnosed adult patients with FLT3-ITD–positive acute myeloid leukemia.

Praveen Ramakrishnan, MD, MS

Praveen Ramakrishnan, MD, MS, discusses the evolution of diffuse large B-cell lymphoma treatment, the implications of key phase 3 studies, and how emerging bispecific T-cell engagers and antibody-drug conjugates may increase treatment accessibility beyond the limitations of CAR T-cell therapy for patients at various disease stages.

In an 8 to 4 vote, the FDA’s Oncologic Drugs Advisory Committee voted that the final overall survival data submitted did not demonstrate a strong enough benefit-risk ratio to support the continued approval of duvelisib for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least 2 prior therapies.

In an 8 to 4 vote, the FDA’s Oncologic Drugs Advisory Committee voted that the final overall survival data submitted did not demonstrate a strong enough benefit-risk ratio for duvelisib for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least 2 prior therapies.