FDA Grants Accelerated Approval to Tafasitamab-Cxix for Diffuse Large B-Cell Lymphoma
On July 31, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval (https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-tafasitamab-cxix-diffuse-large-b-cell-lymphoma) to tafasitamab-cxix (Monjuvi®), 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 an open label, multicenter, single-arm trial (L-MIND; NCT02399085) in 81 patients. Patients received tafasitamab-cxix 12 mg/kg via IV infusion with lenalidomide (25 mg orally on days 1–21 of each 28-day cycle) for a maximum of 12 cycles, followed by tafasitamab-cxix as monotherapy.
Efficacy was based on best overall response rate (ORR), defined as complete and partial response 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.
The recommended tafasitamab-cxix dose is 12 mg/kg via IV infusion.
FDA granted the indication accelerated approval based on ORR. Continued approval for the indication may be contingent on verification and description of clinical benefit in confirmatory trials.
The review used Assessment Aid (https://www.fda.gov/about-fda/oncology-center-excellence/assessment-aid), a voluntary submission from the applicant to facilitate FDA’s assessment. FDA approved this application one month ahead of its goal date.
FDA granted the application priority review, fast track, breakthrough, and orphan product designations. A description of FDA expedited programs is in the Guidance for Industry—Expedited Programs for Serious Conditions—Drugs and Biologics (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/expedited-programs-serious-conditions-drugs-and-biologics).
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm) or by calling 800-FDA-1088.
For assistance with single-patient oncology investigational new drug applications, contact the Oncology Center of Excellence’s Project Facilitate (https://www.fda.gov/about-fda/oncology-center-excellence/project-facilitate) at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov (mailto:OncProjectFacilitate@fda.hhs.gov).