Introduction and listing status of Idecabtagene vicleucel

1. Generic name:Idecabtagene vicleucel Intravenous infusion suspension

Product name:Abecma

2. Indications:

Idecabtagene vicleucel is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T-cell immunotherapy for the treatment of adult patients with multiple myeloma (MM) who have relapsed or refractory after two or more prior therapies, including immunomodulators, proteasome inhibitors and anti-CD38 monoclonal antibodies.

3. Usage and dosage:

Akavilenza is made from the patient's ownT cells, which are extracted from the blood and genetically modified in the laboratory. Akavilenza can only be used in patients whose cells are being used to make drugs. It is given as a single infusion into a vein. Before using Alkavilenza, patients should receive a short course of chemotherapy to clear existing white blood cells. Before the infusion, the patient takes acetaminophen and an antihistamine to reduce the risk of an infusion reaction.

1. Leukapheresis: Collect white blood cells.

2. Manufacturing process: The infusion is manufactured in a specialized laboratory (it takes about4 weeks).

3. Pre-infusion chemotherapy: Patients receive three days of chemotherapy before infusion of Elkavilenza.

4. Infusion: Elkavilenza infusion is performed two days after completion of lymphadenectomy chemotherapy. It is given intravenously through a catheter placed in a vein. Administer premedication 30 to 60 minutes before infusion.

5. Monitoring: For safety monitoring, patients must remain at the treatment center for at least 7 days after infusion and within 2 hours of staying at the facility for 4 weeks.

If the patient has any of the following conditions, the infusion may be delayed by 7 days:

1. Unresolved serious adverse events (especially pulmonary events, cardiac events or hypotension), including events after previous chemotherapy;

2. Active infection or inflammatory disease.

4. Adverse reactions:

In clinical studies of Aqavilenza, the most common adverse reactions included CRS, pyrexia, any infection, febrile neutropenia, hypogammaglobulinemia, musculoskeletal pain, hypotension, infection with unknown pathogens, fatigue, tachycardia, diarrhea, nausea, headache, encephalopathy, dyspnea, and edema.

5. Supply and storage:

Elkivelenza is packaged in one or more infusion bags containing a frozen suspension of transgenic autologous T cells in5% DMSO. Each infusion bag from AKIVIRONSE is individually packaged in a metal box. Aqivilense is stored in the vapor phase of liquid nitrogen and provided via liquid nitrogen dry vapor transporters, including 50 ml, 250 ml, 500 mL infusion bags and metal boxes; frozen Aqivilense is stored in the vapor phase of liquid nitrogen (≤subzero130°C). Thaw Aquivirense before infusion.

6. Mechanism of action:

Akavilenza is a chimeric antigen receptor (CAR) positive T cell therapy targetingB cell maturation antigen (BCMA), which is expressed on the surface of normal and malignant plasma cells. The CAR construct includes an antigen-specific anti-BCMA scFv targeting domain, a transmembrane domain, a CD3-ζ T cell activation domain and a 4-1BB costimulatory domain. Antigen-specific activation of ABECMA results in CAR-positive T cell proliferation, cytokine secretion and subsequent cytolytic killing of BCMA-expressing cells.

7. Listing situation:

Alkavilenza was approved for marketing by the U.S. Food and Drug Administration (FDA) in March 2021, and was approved for use in the EU by the European Medicines Agency (EMA) in August 2021 under the brand name Abecma.

Reference materials:https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b90c1fe7-f5cc-464e-958a-af36e9c26d7c##