Drugs › Bispecific CD20-directed CD3 T cell engager
Brand name · Epcoritamab-bysp
Epkinly: adverse event reports filed with FDA
1,264 reports list it as a suspect or interacting product, 2023–2026. Class: Bispecific CD20-directed CD3 T cell engager.
- 1,264
- reports as suspect product
- 0% of all reports · about 410 a year
- 365
- reports, 12 months to June 2026
- 520 in the 12 months before
- 92.9%
- marked serious by the reporter
- 91.8% across the class
- 33.2%
- record death among outcomes, as reported
- 420 reports · not verified by FDA
Between June 2023 and June 2026, 1,264 adverse event reports received by FDA list the brand name Epkinly (epcoritamab-bysp) as a suspect or interacting product. Reports that mention it only as a concomitant medication (4) are left out of every figure here.
In the 12 months to June 2026, 365 reports listed it, down 30% from 520 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 410 reports a year and 0% of the 20,646,523 reports in the database, and 35.5% of the reports for the bispecific CD20-directed CD3 T cell engager class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded cytokine release syndrome (35.3%), diffuse large B-cell lymphoma (18.4%) and diffuse large B-cell lymphoma refractory (18%). A report can list several reactions, so shares add to more than 100%; 262 different terms appear across these reports. Cytokine release syndrome is recorded in 35.3% of these reports, about the same share as in the median bispecific CD20-directed CD3 T cell engager drug (35.3%).
92.9% of the reports are marked serious by the reporter (91.8% across the class); 33.2% record death among the outcomes and 22.9% record hospitalisation, as reported. 72.8% of the reports came from physicians, and the largest patient age group is 75 and over (40.1%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Epkinly reports recording the termmedian drug in bispecific cd20-directed cd3 t cell engager
- Cytokine release syndrome35.3%446
- Diffuse large B-cell lymphoma18.4%232
- Diffuse large B-cell lymphoma refractory18%228
- Pyrexiafever10.1%128
- Cytomegalovirus infection reactivation4.3%54
- Covid-19COVID-19 infection4.1%52
- Platelet count decreasedlow platelet count3.6%45
- Hypogammaglobulinaemia3.4%43
- Pneumonialung infection3.1%39
- Deaththe patient died; cause not stated by this term2.8%36
- Sepsisa severe body-wide response to infection2.1%27
- Off label useused for a purpose or in a way not on the label2.1%26
- Anaemialow red blood cells2%25
- Cytomegalovirus test positive2%25
- Neutropenialow neutrophils, a type of white blood cell2%25
- Drug ineffectivethe medicine did not work as expected1.9%24
- Malaisegeneral feeling of being unwell1.9%24
- Deliriumsudden confusion1.8%23
- Hospitalisationadmission to hospital1.8%23
- Infectionan infection, type not specified1.8%23
- Fatiguetiredness1.7%22
- Inappropriate schedule of product administrationthe product was taken at the wrong times1.7%21
- Tumour pseudoprogression1.7%21
- Abdominal painstomach or belly pain1.6%20
- Adverse eventan unwanted medical event, type not specified1.6%20
Top 30 of 262 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 3 drugs in the bispecific cd20-directed cd3 t cell engager class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 3,559 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 19.3% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Diffuse large b-cell lymphoma refractory | 469 | 37.1% |
| Diffuse large b-cell lymphoma | 421 | 33.3% |
| Diffuse large b-cell lymphoma recurrent | 49 | 3.9% |
| B-cell lymphoma refractory | 29 | 2.3% |
| Follicular lymphoma | 28 | 2.2% |
| Follicular lymphoma refractory | 24 | 1.9% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,264 reports.
In context
| Measure | Epkinly | Bispecific CD20-directed CD3 T cell engager | All reports |
|---|---|---|---|
| Reports as suspect product | 1,264 | 3,559 | 20,646,523 |
| Share of that pool | — | 35.5% | 0% |
| Reports, latest 12 months | 365 | — | 1,332,454 |
| Marked serious | 92.9% | 91.8% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 332 | 314 | 91 |
| Hospitalisation recorded, per 1,000 reports | 229 | 292 | 213 |
| Consumer-filed share | 5% | 12.4% | 45.8% |
| Top term, share of reports | Cytokine release syndrome 35.3% | median 35.3% | 0.1% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the bispecific cd20-directed cd3 t cell engager class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Glofitamab | generic | 1,537 | 523 | 96.2% |
| Columvi | brand | 758 | 325 | 81.1% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Epkinly reports
How many adverse event reports has FDA received for Epkinly?
1,264 reports list Epkinly as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 365 of them arrived in the latest 12 months. Another 4 list it only as a concomitant medication.
What reactions are recorded in Epkinly reports?
cytokine release syndrome (35.3%), diffuse large B-cell lymphoma (18.4%), diffuse large B-cell lymphoma refractory (18%), pyrexia (10.1%) and immune effector cell-associated neurotoxicity syndrome (8.1%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Epkinly was responsible.
How serious are the reports?
92.9% are marked serious by the reporter. Among the outcomes recorded, 33.2% of reports include death and 22.9% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
physician (72.8%), pharmacist (11.8%) and other health professional (10.4%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Epkinly rising?
365 reports in the 12 months to June 2026, down 30% from 520 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Epkinly was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Epkinly?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Epkinly as a suspect or interacting product; reports listing it only as a concomitant medication (4) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.