According to a story from BioSpace, the biopharmaceutical company Kite announced recently that the Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency, has released a positive opinion for the company’s Marketing Authorization Application. This application is in regards to KTE-X19, which is a CAR T-cell therapy being developed as a treatment for adults with mantle cell lymphoma that is refractory or relapsed.
About Mantle Cell Lymphoma
Mantle cell lymphoma is a rare type of non-Hodgkin’s lymphoma. There are only about 15,000 patients in the US. This blood cancer affects B-cells, a type of white blood cell. The risk factors for mantle cell lymphoma are not particularly well known; however, acquired genetic mutations in the affected cells are what eventually causes them to become malignant. Most patients are diagnosed in their 60s. In many cases, the disease is not diagnosed until it has reached an advanced stage. Symptoms include fever, night sweats, enlarged spleen and lymph nodes, and weight loss. Treatment options include immunotherapy, chemotherapy, and targeted therapies. Mantle cell lymphoma often relapses after treatment with chemotherapy. Prognosis is difficult to predict; the five year survival rate is 50 percent, but this figure improves to 70 percent with limited-stage disease. To learn more about mantle cell lymphoma, click here.
Conditional Authorization Recommended
In its positive opinion, CHMP has recommended a conditional authorization. This is an approval pathway for treatments that have the potential to have promising effects but lack comprehensive data and have the potential to address an unmet need. Conditional status lasts for a single year but can changed to unconditional status or extended once new data has been established. KTE-X19 is being investigated in an ongoing phase 2 clinical trial.
About KTE-X19
KTE-X19 is a form of CAR T-cell therapy that targets CD19. In these therapies, which are primarily used for blood cancers, a type of white blood cell called T-cells are extracted from the body of the patient. These cells are then modified to target cancerous cells and propagated in the lab setting before being reintroduced into the patient’s body. The therapy has earned Priority Medicines (PRIME) designation from the EMA. A final decision from the European Commission for the approval of KTE-X19 is anticipated in the next few months.
