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https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-tafasitamab-cxix-diffuse-large-b-cell-lymphoma

FDA grants accelerated approval to tafasitamab-cxix for diffuse large B-cell lymphoma

On July 31, 2020, the Food and Drug Administration granted
accelerated approval to tafasitamab-cxix (MONJUVI, MorphoSys US Inc.), a
CD19-directed cytolytic antibody, indicated in combination with
lenalidomide for adult patients with relapsed or refractory diffuse
large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL
arising from low grade lymphoma, and who are not eligible for autologous
stem cell transplant.

The efficacy of tafasitamab-cxix with lenalidomide was evaluated in L-MIND (NCT02399085),an
open label, multicenter single-arm trial in 81 patients. Patients
received tafasitamab-cxix 12 mg/kg intravenously with lenalidomide (25
mg orally on days 1 to 21 of each 28-day cycle) for maximum of 12
cycles, followed by tafasitamab-cxix as monotherapy.

Efficacy was based on best overall response rate (ORR), defined as
complete and partial responders and response duration, as assessed by an
independent review committee. The best ORR in 71 patients with a
diagnosis of DLBCL confirmed by central pathology was 55% (95% CI: 43%,
67%), with complete responses in 37% and partial responses in 18% of
patients. Median response duration was 21.7 months (range: 0, 24).

The most common adverse reactions (≥20%) were neutropenia, fatigue,
anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema,
respiratory tract infection, and decreased appetite.