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The FDA has granted a priority review designation to tisagenlecleucel-T as a treamtnet for pediatric and young adult patients with relapsed and refractory B-cell acute lymphoblastic leukemia, making it the first CAR T-cell therapy to enter regulatory review.

The EMA’s Committee for Medicinal Products for Human Use has recommended approval of pembrolizumab for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma who have progressed following autologous stem cell transplant and brentuximab vedotin, or who are transplant-ineligible and have failed brentuximab vedotin.