US FDA approved second gene therapy product Yescarta that contains axicabtagene ciloleucel as an active pharmaceutical ingredient. It is basically cell based gene therapy that is used to target certain types of B-cell lymphoma in patients who are not responding to traditional therapy. FDA also indicated this drug in case of relapsed after using at least two other kinds of treatment.
B-cell lymphoma is a kind of blood cancer that affects lymph nodes. Lymphoma is more common in people who are immunocompromised and in older adults. They usually are of two types slow growing and rapidly growing lymphomas. Life expectancy and survival rate mainly depends upon stage, specific type and over all health of individual. Early detection is the key factor in the detection of such kind of cancers. Main components of treatment include chemotherapy and radiations. Symptoms of B-cell lymphoma are not so obvious in early stage or patients neglect them due to insignificant severity.
Yescarta/axicabtagene ciloleucel is targeted therapy to treat b-cell lymphoma but it is also associated with some risk factors like cytokines release syndrome so, US FDA instructed its usage in hospitals be certified for its use. Yescarta/axicabtagene is categorized as chimeric antigen receptor (CAR) T cell therapy that is approved by US FDA for various types of non-Hodgkin lymphoma.
Yescarta/axicabtagene Side effects
Following side effects were observed during clinical trials of Yescarta.
- Cytokine release syndrome (Boxed warning)
- High grade fever
- Flu like symptoms
- Neurlogical disturbance
- Reaction at site of injection
- Sleeping problems
- Body pain
Yescarta/axicabtagene Uses/Prescribing Information
Yescarta/axicabtagene is formulated as Single-dose units contain specific amounts of T cells depending on the patient’s body weight that are suspended in a patient-specific infusion bag. Target dose is 2 x 10^6 CAR-positive viable T cells/kg body weight.