Generic Name: axicabtagene ciloleucel
Trade Name: YESCARTA®
For which conditions is YESCARTA approved for? YESCARTA is indicated for the treatment of adult patients with:
- Relapsed or refractory large B-cell lymphomas after two or more treatments. The large B-cell lymphomas including in this indication are diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. YESCARTA is not indicated for patients with primary central nervous system lymphoma.
- Relapsed or refractory follicular lymphoma after two or more treatments. This indication is approved under accelerated approval based on response rate and verification of benefit will be evaluated in additional clinical trials.
- The labeling contains a boxed warning to alert healthcare professionals and patients about potential severe and or life-threatening side effects including cytokine release syndrome (CRS) and neurological toxicities.
What is the mechanism of action? YESCARTA is a genetically-modified autologous T-cell immunotherapy. Chimeric Antigen Receptor (CAR) T-cell therapy is a new type of treatment that utilizes a patient’s own T-cells (a type of immune cell) to fight certain types of blood cancers. The T-cells are removed from the patient and engineered to recognize specific proteins found on the surface of cancer cells. The T-cells are then infused back into the patient to fight the cancer in their body.
How is YESCARTA typically given (administered)? Each dose of YESCARTA is a customized treatment created using an individual patient’s own T-cells, a type of white blood cell known as a lymphocyte. A patient’s T-cells are collected in a 3-6 hour procedure called leukopheresis and sent to a manufacturing center where they are genetically modified to include a new gene that contains a specific protein (a chimeric antigen receptor or CAR) that directs the T-cells to target and kill cancer cells that have a specific antigen (CD19) on the surface. Before treatment with YESCARTA, your healthcare provider may give you chemotherapy for a few days to prepare your body. Once the cells are modified, they are infused back into the patient to kill the cancer cells. The infusion of YESCARTA usually takes less than one hour. Because of the risk of CRS and neurological events, YESCARTA is being approved with a risk evaluation and mitigation strategy (REMS), which includes elements to assure safe use (ETASU). The FDA is requiring that hospitals and their associated clinics that dispense YESCARTA be specially certified. CRS can be treated with the drug tocilizumab (with or without corticosteroids) and tocilizumab must be onsite prior to infusion.
How are patients typically monitored? Before taking YESCARTA, discuss any medical conditions with your healthcare provider, including neurological, lung, breathing, heart, liver or kidney problems as well as a recent or active infection. Healthcare professionals involved in the prescribing, dispensing, or administering of YESCARTA are required to be trained to recognize and manage CRS and neurological events. Additionally, the certified health care settings are required to have protocols in place to ensure that YESCARTA is only given to patients after verifying that tocilizumab is available for immediate administration. The REMS program specifies that patients be informed of the signs and symptoms of CRS and neurological toxicities following infusion – and of the importance of promptly returning to the treatment site if they develop fever or other adverse reactions after receiving treatment with YESCARTA.
YESCARTA is not recommended for women who are pregnant, and pregnancy after YESCARTA should be discussed with the treating physician.
What are the most common side effects of treatment with YESCARTA?
- Low white blood cells
- Low red blood cells
- Abnormally low blood pressure (dizziness, lightheadedness, headache, feeling tired, shortness of breath)
- Increased heart rhythm
- Difficulty speaking or slurred speech
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
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Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain other medicines may affect how YESCARTA works and can cause side effects. YESCARTA may cause severe or life-threatening side effects and it is important that you call your healthcare provider or get emergency help right away if you experience difficulty breathing; fever higher than 100.4°F; chills/shaking chills; confusion; severe nausea, vomiting, or diarrhea; fast or irregular heartbeat; severe fatigue or weakness; and/or dizziness/lightheadedness. If you seek emergency care, it is important to let your healthcare providers know that you have received YESCARTA.
Are there any special precautions patients should be aware of before starting treatment?
- Talk to your healthcare provider about any medicines (prescription and over-the-counter), vitamins or herbal supplements that you are taking.
- YESCARTA can affect your ability to drive and use machines, avoid operating heavy or potentially dangerous machinery for at least 8 weeks following treatment with YESCARTA.
- Talk to your doctor about the risk of manufacturing failure of YESCARTA.
- Do not donate blood, organs, tissues and cells for transplantation.
When should patients notify their physician?
Tell your doctor if you experience any side effects that bother you or don’t go away. YESCARTA may cause severe or life-threatening side effects and it is important that you call your healthcare provider or get emergency help right away if you experience difficulty breathing; fever higher than 100.4°F; chills/shaking chills; confusion; severe nausea, vomiting, or diarrhea; fast or irregular heartbeat; severe fatigue or weakness; and/or dizziness/lightheadedness. If you seek emergency care, it is important to let your healthcare providers know that you have received YESCARTA and show them your YESCARTA Patient Wallet Card.
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
Important Limitations of Use
The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.
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