Pharmacologic class (EPC) · 3 drug pages

Bispecific CD20-directed CD3 T cell engager: adverse event reports filed with FDA

3,559 reports list a drug in this class as a suspect or interacting product, 2018–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

3,559
reports across the class: 0% of all reports; 1,213
reports, 12 months to June 2026: 1,145 in the 12 months before; 91.8%
marked serious by the reporter: 57.4% across all reports; 3
drugs with a page: brand and generic names counted separately

Bispecific CD20-directed CD3 T cell engager is a pharmacologic class (an FDA Established Pharmacologic Class) with 3 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 3,559 adverse event reports received by FDA, 0% of the database, from November 2018 to June 2026.

1,213 reports arrived in the 12 months to June 2026, close to the 1,145 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 91.8% of the class's reports are marked serious, 31.4% record death among the outcomes and 29.2% record hospitalisation, as reported.

Across the class the reactions recorded most often are cytokine release syndrome (33.2%), disease progression (12.3%) and pyrexia (8.9%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
Glofitamab	generic	1,537	523	96.2%	Cytokine release syndrome
EpkinlyEpcoritamab-bysp	brand	1,264	365	92.9%	Cytokine release syndrome
ColumviGlofitamab	brand	758	325	81.1%	Cytokine release syndrome

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Cytokine release syndrome33.2%1,183
Disease progressionthe disease advanced12.3%436
Pyrexiafever8.9%318
Deaththe patient died; cause not stated by this term8.7%310
Off label useused for a purpose or in a way not on the label8.2%292
Diffuse large B-cell lymphoma7.6%272
Immune effector cell-associated neurotoxicity syndrome6.7%240
Diffuse large B-cell lymphoma refractory6.6%234
Neutropenialow neutrophils, a type of white blood cell5.6%198
Covid-19COVID-19 infection4.6%162
Pneumonialung infection3.4%122
Febrile neutropeniafever with low white blood cells3.3%116
Anaemialow red blood cells3.2%115
Infectionan infection, type not specified3.1%112
Malignant neoplasm progression3.1%109
Drug ineffectivethe medicine did not work as expected2.9%103
Thrombocytopenialow platelets2.6%93
Platelet count decreasedlow platelet count2.4%87
Cytomegalovirus infection reactivation2.3%81
Sepsisa severe body-wide response to infection2.1%75
Alanine aminotransferase increasedraised liver enzyme (ALT)2.1%73
Neutrophil count decreased2%72
Diffuse large B-cell lymphoma recurrent1.9%68
Hypogammaglobulinaemia1.9%68
No adverse eventno adverse event was reported1.6%58

Solid bar: share of all class reports. Hollow bar: the median share across the 3 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death31.4%1,118

Life-threatening4.2%150

Hospitalisation (initial or prolonged)29.2%1,038

Disability0.5%18

Congenital anomaly0%0

Other serious62.9%2,240

Not serious8.2%292

Patient age

Under 20%0

2 to 110.4%15

12 to 170.8%27

18 to 445.1%182

45 to 6421.6%769

65 to 7422.1%788

75 and over23%818

Age not given27%960

Who reported

Physician66.7%2,374

Pharmacist7.8%276

Other health professional13%461

Lawyer0%0

Consumer or non-health professional12.4%442

Not given0.2%6

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Bispecific CD20-directed CD3 T cell engager reports

Which drugs are in the Bispecific CD20-directed CD3 T cell engager class on this site?

Glofitamab, Epkinly and Columvi. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

3,559 reports through June 2026, 1,213 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

cytokine release syndrome (33.2%), disease progression (12.3%), pyrexia (8.9%), death (8.7%) and off label use (8.2%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. 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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.