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All Oncology News

FDA

The FDA has extended the review period for a 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.

Matthew H. Taylor, MD

Findings from a phase 1 study showed that the fully humanized IgG4 antibody IO-108 was well tolerated and displayed durable responses when given as a monotherapy as well as in combination with pembrolizumab, supporting further development of the agent alone or with PD-1/PD-L1 targeted therapy for patients with advanced solid tumors.

The FDA has approved polatuzumab vedotin-piiq (Polivy) plus rituximab (Rituxan), cyclophosphamide, doxorubicin, and prednisone for use in adult patients who have previously untreated diffuse large B-cell lymphoma, not otherwise specified or high-grade B-cell lymphoma and who have an International Prognostic Index score of two or greater.

The FDA has approved polatuzumab vedotin-piiq (Polivy) plus rituximab (Rituxan), cyclophosphamide, doxorubicin, and prednisone for use in adult patients who have previously untreated diffuse large B-cell lymphoma, not otherwise specified or high-grade B-cell lymphoma and who have an International Prognostic Index score of two or greater.