actalycabtagene autoleucel

Action and Spectrum

Actions and spectrum: 

They utilize CAR T-cell therapy to treat relapsed/refractory B-cell lymphomas and leukemia. It incorporates a humanized CAR protein designed to target CD19 on B-cells.  

The modified T-cells are linked with CAR19, then infused back into the patient where they identify and attack CD19-positive cancer cells. 

Drug Interaction

Adverse Reaction

Frequency not defined  

Fever  

Weakness or severe fatigue  

Confusion  

Difficulty breathing  

Diarrhea  

Vomiting  

Black Box Warning

Black Box Warning:  

At least eight weeks following treatment, it is necessary to avoid activities such as driving, engaging in other hazardous tasks, or operating heavy machinery because the treatment may induce sleepiness, weakness, confusion, and temporary issues with memory. 

Contraindication / Caution

Contraindication/Caution:  

None  

Pregnancy / Lactation

Pregnancy Warnings: 

Pregnancy category: N/A 

Lactation: Excretion of the drug into the human breast milk is unknown 

Pregnancy categories: 

• Category A: Satisfactory and well-controlled studies show no evidence of risk to the fetus in the first trimester or in the later trimester. 
• Category B: No evidence of risk to fetus found in animal reproduction studies and there are not enough studies on pregnant women. 
• Category C: Adverse effects on the fetus found with evidence in animal reproduction studies and no adequate evidence for an effect in humans, care must be taken for potential risks in pregnant women. 
• Category D: There is adequate data available with sufficient evidence of human fetal risk from various platforms, but despite potential risks may be used only in emergency cases for potential benefits. 
• Category X: Drugs listed in this category clearly outweigh risks over benefits. These category drugs should be prohibited for pregnant women. 
• Category N: There is no data available for the drug under this category 

Pharmacology

Pharmacology:   

The CAR19 T-cells identify and attack the cancerous B-cells which contribute to an overall immune response against malignancy. This allows specifically to target and eliminate cancer cells with CD19 expression along with providing a personalized and targeted approach to cancer treatment. 

Pharmacodynamics:  

The study focuses on Actaly-cel, it is a Humanized CD19-directed CAR T-cell therapy with relapsed-refractory B-cell Acute Lymphoblastic Leukemia.  

The therapy has shown promising results in pre-clinical studies, leading to regulatory approval for Phase-1 and Phase 1b/2 trials.  

Pharmacokinetics: 

Limited information is available on ADME.  

Adminstartion

Administration:  

It is administered via intravenous infusion.  

Patient Information Leaflet

Patient information leaflet  

Generic Name: actalycabtagene autoleucel  

Why do we use actalycabtagene autoleucel?  

Actalycabtagene autoleucel is indicated in the treatment of relapsed or refractory large B-cell lymphoma.