Hematology

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Copanlisib (BAY 80-6946), a novel PI3K inhibitor, is being combined with standard rituximab (Rituxan)-based regimens in patients with relapsed, indolent non-Hodgkin lymphoma (NHL) in 2 phase III clinical trials that investigators hope will expand treatment options in refractory disease settings, particularly with less toxic alternatives.

Tisagenlecleucel (Kymriah), Novartis' newly approved CAR T-cell therapy, will be put on the market with a price of $475,000 for a single infusion, an amount that is within the range anticipated by oncologists and that Novartis characterized as well below a price level that could be justified on cost.

The FDA has approved CPX-351 (Vyxeos), a fixed-combination of daunorubicin and cytarabine, for adult patients with either newly-diagnosed therapy-related acute myeloid leukemia (t-AML) ot AML with myelodysplasia-related changes (AML-MRC).