FDA approved Adcetris (brentuximab vedotin) in combination with lenalidomide and a rituximab product for adult patients with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are ineligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or CAR T-cell therapy.
In the latest episode of Vinay Prasad’s extraordinary adventures at FDA, the agency (i.e. Dr. Prasad himself) has issued a Refusal-to-File letter to an mRNA-based influenza vaccine application.
