Tabelecleucel, sold under the brand name Ebvallo, is a

medication Medication (also called medicament, medicine, pharmaceutical drug, medicinal product, medicinal drug or simply drug) is a drug used to medical diagnosis, diagnose, cure, treat, or preventive medicine, prevent disease. Drug therapy (pharmaco ...

used for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD). Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Tabelecleucel is an

allogeneic Allotransplant (''allo-'' meaning "other" in Greek) is the transplantation of cells, tissues, or organs to a recipient from a genetically non-identical donor of the same species. The transplant is called an allograft, allogeneic transplant, ...

, EBV-specific

T-cell T cells (also known as T lymphocytes) are an important part of the immune system and play a central role in the adaptive immune response. T cells can be distinguished from other lymphocytes by the presence of a T-cell receptor (TCR) on their ce ...

immunotherapy which targets and eliminates EBV-infected cells in a

human leukocyte antigen The human leukocyte antigen (HLA) system is a complex of genes on chromosome 6 in humans that encode cell-surface proteins responsible for regulation of the immune system. The HLA system is also known as the human version of the major histo ...

(HLA)-restricted manner. It is made of cells of the immune system called T-cells that have been taken from the recipient (allogeneic) and are then mixed with EBV-infected B-cells from the same donor. The most common side effects include fever, diarrhea, fatigue, nausea (feeling sick), anemia (low red blood cell count), reduced appetite, hyponatremia (low sodium levels in the blood), abdominal pain, low white blood cell count, including neutrophils (white blood cells that fight infections), elevated blood levels of aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase (indicators of potential liver damage), constipation, hypoxia (low blood oxygen levels), dehydration, hypotension (low blood pressure), nasal congestion, and rash. Tabelecleucel was approved for medical use in the European Union in December 2022.

Medical uses

Tabelecleucel is

indicated In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. There can be multiple indications to use a procedure or medication. An indication can commonly be confused with the term diagnosis. A diagnosis ...

as monotherapy for treatment of people aged two years of age and older with relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy.

Post-transplant lymphoproliferative disorder

People who have undergone organ transplantation are routinely treated with

immunosuppressive drug Immunosuppressive drugs, also known as immunosuppressive agents, immunosuppressants and antirejection medications, are drugs that inhibit or prevent the activity of the immune system. Classification Immunosuppressive drugs can be classifie ...

s to prevent

transplant rejection Transplant rejection occurs when transplanted tissue is rejected by the recipient's immune system, which destroys the transplanted tissue. Transplant rejection can be lessened by determining the molecular similitude between donor and recipien ...

. As a result of the treatment, some people develop Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (PTLD) in which white blood cells become infected with EBV and which in turn triggers excessive division of those cells. PTLD is initially non-cancerous, but can progress to cancerous

Hodgkin lymphoma Hodgkin lymphoma (HL) is a type of lymphoma in which cancer originates from a specific type of white blood cell called lymphocytes, where multinucleated Reed–Sternberg cells (RS cells) are present in the lymph nodes. The condition was named a ...

First-line treatment A therapy or medical treatment is the attempted remediation of a health problem, usually following a medical diagnosis. Both words, ''treatment'' and ''therapy'', are often abbreviated tx, Tx, or Tx. As a rule, each therapy has indications an ...

s of PTLD include monoclonal antibodies such as

rituximab Rituximab, sold under the brand name Rituxan among others, is a monoclonal antibody medication used to treat certain autoimmune diseases and types of cancer. It is used for non-Hodgkin lymphoma, chronic lymphocytic leukemia (in children and ad ...

and

chemotherapy Chemotherapy (often abbreviated chemo, sometimes CTX and CTx) is the type of cancer treatment that uses one or more anti-cancer drugs (list of chemotherapeutic agents, chemotherapeutic agents or alkylating agents) in a standard chemotherapy re ...

if cancer has developed.

Adverse effects

The most common side effects are

fever Fever or pyrexia in humans is a symptom of an anti-infection defense mechanism that appears with Human body temperature, body temperature exceeding the normal range caused by an increase in the body's temperature Human body temperature#Fever, s ...

diarrhea Diarrhea (American English), also spelled diarrhoea or diarrhœa (British English), is the condition of having at least three loose, liquid, or watery bowel movements in a day. It often lasts for a few days and can result in dehydration d ...

, tiredness, feeling sick, low levels of red blood cells, decreased appetite and low blood sodium levels.

History

The EMA recommendation is based on the results of an ongoing multicenter, phase III, single-arm, open-label clinical trial. The study investigated the efficacy and safety of tabelecleucel in 43 participants with relapsed/refractory EBV+ PTLD who had received at least one prior therapy.

Society and culture

Legal status

On 13 October 2022, the

Committee for Medicinal Products for Human Use The Committee for Medicinal Products for Human Use (CHMP), formerly known as the Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regar ...

(CHMP) of the

European Medicines Agency The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products ...

(EMA) adopted a positive opinion, recommending the granting of a marketing authorization under exceptional circumstances for the medicinal product Ebvallo, intended for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD). As Ebvallo is an advanced therapy medicinal product, the CHMP positive opinion is based on an assessment by the Committee for Advanced Therapies. The applicant for this medicinal product is Atara Biotherapeutics Ireland Limited. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Tabelecleucel was approved for medical use in the European Union in December 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

References

External links

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