Treats relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise…. BLA 761324, held by Genmab US, Inc.. Epcoritamab-Bysp.
As of Nov 13, 2026, BLA 761324 (Epkinly), held by Genmab US, Inc., was first approved by FDA on May 19, 2023, with 5 approved supplements and 0 published complete response letters.
EPKINLY is a bispecific CD20-directed CD3 T-cell engager indicated: For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 27, 2026 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Nov 18, 2025 | Supplement 9Efficacy (new indication or use) · Priority review | Approved | |
| Jun 26, 2024 | Supplement 3Efficacy (new indication or use) · Priority review | Approved | |
| May 19, 2023 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Epkinly4MG/0.8ML · injectable;subcutaneous | Epcoritamab-Bysp | Rx |
| Epkinly48MG/0.8ML · injectable;subcutaneous | Epcoritamab-Bysp | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 17, 2026 | Supplement 11Labeling · Standard review | Approved | |
| Mar 27, 2026 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Nov 18, 2025 | Supplement 9Efficacy (new indication or use) · Priority review | Approved | |
| Sep 11, 2025 | Supplement 8Labeling · Standard review | Approved | |
| Jun 26, 2024 | Supplement 3Efficacy (new indication or use) · Priority review | Approved | |
| May 19, 2023 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
