Multiple Myeloma

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-9"></a><p></p><h1>11 DESCRIPTION</h1><p class="First">ABECMA is a BCMA-directed genetically modified autologous T cell immunotherapy product consisting of a patient's own T cells that are harvested and genetically modified <span class="Italics">ex vivo</span> through transduction with an anti-BCMA02 chimeric antigen receptor (CAR) lentiviral vector (LVV). Autologous T cells transduced with the anti-BCMA02 CAR LVV express the anti-BCMA CAR on the T cell surface. The CAR is comprised of a murine extracellular single-chain variable fragment (scFv) specific for recognizing B cell maturation antigen (BCMA) followed by a human CD8α hinge and transmembrane domain fused to the T cell cytoplasmic signaling domains of CD137 (4-1BB) and CD3ζ chain, in tandem. Binding of ABECMA to BCMA-expressing target cells leads to signaling initiated by CD3ζ and 4-1BB domains, and subsequent CAR-positive T cell activation. Antigen-specific activation of ABECMA results in CAR-positive T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells.</p><p>ABECMA is prepared from the patient's peripheral blood mononuclear cells (PBMCs), which are obtained via a standard leukapheresis procedure. The mononuclear cells are enriched for T cells, through activation with anti-CD3 and anti-CD28 antibodies in the presence of IL-2, which are then transduced with the replication-incompetent lentiviral vector containing the anti-BCMA CAR transgene. The transduced T cells are expanded in cell culture, washed, formulated into a suspension, and cryopreserved. The product must pass a sterility test before release for shipping as a frozen suspension in one or more patient-specific infusion bag(s). The product is thawed prior to infusion back into the patient <span class="Italics">[see <a href="#S2.3">Dosage and Administration (2.3)</a> and <a href="#S16">How Supplied/Storage and Handling (16)</a>].</span></p><p>The ABECMA formulation contains 50% Plasma-Lyte A and 50% CryoStor<span class="Sup">®</span> CS10, resulting in a final DMSO concentration of 5%.</p></section>

Abecma

idecabtagene vicleucel

30 ML idecabtagene vicleucel 15333333 CELLS/ML Injection

30 ML idecabtagene vicleucel 15333333 CELLS/ML Injection [Abecma]

70 ML idecabtagene vicleucel 6571428 CELLS/ML Injection

70 ML idecabtagene vicleucel 6571428 CELLS/ML Injection [Abecma]

100 ML idecabtagene vicleucel 4600000 CELLS/ML Injection

100 ML idecabtagene vicleucel 4600000 CELLS/ML Injection [Abecma]

Psoriasis (PsO)

Psoriatic Arthritis (PsA)

Ankylosing Spondylitis (AS)

Nonradiographic Axial Spondyloarthritis

Taltz

Juvenile Idiopathic Arthritis

Hidradenitis Suppurativa (HS)

Cosentyx

Siliq

Tremfya

Crohn's Disease (CD)

Ulcerative Colitis (UC)

Stelara

Skyrizi

Ilumya

Migraine

Cluster Headache

Migraine Prevention

Emgality

Qulipta

Acute Migraine

Ubrelvy

Nurtec ODT

Vyepti

Aimovig

Ajovy

Breast Cancer: HR+ (HER2-)

Verzenio

Ibrance

Kisqali

Atopic Dermatitis (Eczema)

Cibinqo

Eucrisa

Asthma (injectable)

Asthma OCS Dependent

Nasal Polyposis

Eosinophilic Esophagitis (EoE)

Prurigo Nodularis

Dupixent

Opzelura

Adbry

NSCLC ALK+ OR ROS1+ Disease

Lorbrena

Alecensa

Alunbrig

NSCLC cMET Mutation

Xalkori

Rheumatoid Arthritis (RA)

Xeljanz

Uveitis

Graft Versus Host Disease (GVHD)

Orencia

COVID-19 Treatment

Alopecia Areata

Olumiant

Multiple Sclerosis (MS)

Secondary Progressive Multiple Sclerosis

Zeposia

Rinvoq

Entyvio

Report Adverse Event 

Prescribing Information 

Medication Guide 

Submit MSL Request 

Pharmacy List 

Formulary Information 

Treatment Centre Locator 

Coverage Authorization Request 

Coverage Authorization Appeals 

Letter of Medical Necessity 

Reimbursement Information 

Referral Process

Enroll in Patient Savings Program 

Cell Therapy 360 Patient Assistance Program 

Other HCP Resources 

About Abecma 

Patient Brochure 

Receiving Abecma 

Comprehensive Support Program 

Side Effects 

Instructions For Use - Relapsed/Refractory Multiple Myeloma 

Patient Stories 

Patient Resources 