Yescarta

What is Yescarta?

Yescarta Overview:

Yescarta (axicabtagene ciloleucel) is an individualized immunotherapy medication administered via intravenous infusion, designed to address specific conditions in adults.

Indications:

Yescarta is utilized in the treatment of:

1. Large B-cell lymphoma unresponsive to initial chemoimmunotherapy or recurring within 12 months of the initial treatment.
2. Relapsed or refractory large B-cell lymphoma after failure of at least two prior treatments.
3. Follicular lymphoma when at least two treatments have not effectively controlled the cancer. Approval for this indication is under the accelerated approval scheme, with continued approval contingent on clinical trial results.

Exclusions:

Not intended for patients with primary central nervous system lymphoma.

Mechanism of Action:

Yescarta incorporates modified T-cells derived from the patient’s own blood, enhanced in a laboratory. These T-cells, vital for immune response, undergo a process where a special receptor (CAR – chimeric antigen receptor) is added. The CAR boosts T-cells’ ability to attach to CD19-expressing cancer cells, facilitating their destruction. This approach is termed CD19-directed genetically modified autologous T-cell immunotherapy.

Clinical Study (ZUMA-7):

The ZUMA-7 study demonstrated a statistically significant improvement in overall survival (OS) with Yescarta compared to standard treatment for relapsed or refractory large B-cell lymphoma within 12 months of completing first-line treatment.

FDA Approval:

Yescarta received FDA approval on October 18, 2017.

Warnings:

Yescarta carries risks of cytokine release syndrome (CRS), causing symptoms like fever, chills, and respiratory distress. It may also lead to life-threatening nerve problems. Additionally, there’s an increased infection risk, potential decrease in albumin or immunoglobulin levels, and elevated risk of secondary cancers. Yescarta can impact driving ability and is available only through the Yescarta and Tecartus REMS (Risk Evaluation and Mitigation Strategy) program.

Before Taking Yescarta:

• Medical History: Ensure your doctor is informed if you’ve had recent infections, stroke, memory issues, seizures, lung problems, liver or kidney disease, or heart problems.
• Vaccination: Avoid live virus vaccines for at least 6 weeks before lymphodepleting chemotherapy, during Yescarta treatment, and until immune system recovery post-treatment.
• Pregnancy and Breastfeeding: Pregnancy testing is conducted before treatment, and birth control is advised during and shortly after Yescarta and chemotherapy. Breastfeeding safety should be discussed with the doctor.

Administration of Yescarta:

• Authorized Settings: Yescarta is available only at authorized hospitals or clinics and must be administered by trained healthcare professionals.
• Leukapheresis Procedure: Prior to Yescarta, leukapheresis is conducted to collect white blood cells. These cells are then sent to a laboratory for modification into Yescarta.
• Chemotherapy Pre-Treatment: 3 to 5 days before Yescarta administration, chemotherapy is given to prepare the body.
• Medication Administration: Yescarta is injected into a vein through an IV. Patients are monitored for at least 7 days post-administration.
• Post-Treatment Period: Frequent blood tests and proximity to the hospital or clinic for 4 weeks are advised.

Missed Dose and Overdose:

• Missed Dose: Consult the doctor for instructions if any chemotherapy treatment or medication doses are missed.
• Overdose: Unlikely due to professional administration.

Post-Treatment Precautions:

Avoid driving or operating machinery for at least 8 weeks post-Yescarta treatment.

Side Effects of Yescarta:

Common side effects include CRS, fever, low blood pressure, brain dysfunction, fatigue, rapid heartbeat, headache, nausea, diarrhea, muscle pain, infections, chills, and decreased appetite.

Interactions:

Inform your doctor about all current medications, as systemic corticosteroids may interfere with Yescarta’s activity.

Storage:

Yescarta infusion bags are stored frozen in the vapor phase of liquid nitrogen.

Ingredients:

Active ingredient: axicabtagene ciloleucel.
Inactive ingredients: albumin (human), DMSO (dimethylsulfoxide).

This detailed exploration provides comprehensive insights into Yescarta’s usage, warnings, administration, and associated considerations, aiding in informed decision-making for patients and healthcare professionals.