As a personalized medicine, CARVYKTI™ treatment requires extensive training, preparation, and certification to ensure a positive patient experience. It is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the CARVYKTI™ REMS program. Safety information for this therapy includes a warning on Cytokine Release Syndrome, Immune Effector Cell-Associated Neurotoxicity Syndrome, Parkinson’s disease, Guillain-Barré syndrome, hemophagocytic lymphohistiocytosis/macrophage activation syndrome, and persistent or recurrent cytopenia2.

Ultrasound and magnetic resonance imaging (MRI) are frequent tools to evaluate if an area is a tumor candidate. However, in most cases, the only way to definitively diagnose cancer is to take a biopsy and look at those suspicious cells under a microscope. Sometimes, a biopsy will show that the suspected area contains only benign cells, indicating that treatments, such as surgery, radiation therapy, or chemotherapy are not needed. In other cases, a biopsy can discern how aggressive the cancer is and how advanced (stage and grade) the disease is. Furthermore, it can ease the determination of the type of cancer cells in the tumor. Together, this information can support the decision of the best course of action to treat cancer1.

Doctors remove a small portion of tissue from the suspected tumor or affected area during a biopsy. There are many different techniques for performing biopsies. For example, in a fine-needle aspiration biopsy, a doctor inserts a needle attached to a syringe into the suspicious area to remove a small amount of tissue for diagnosis. Another approach is an excisional biopsy, in which the doctor removes the entire suspicious mass for examination. Many biopsies are performed under imaging guidance, called image-guided biopsies, which use ultrasounds or computed tomography (CT) scans to locate problematic areas and collect samples1.