We all know how important clinical trials are. The FDA has approved Yescarta (axicabtagene ciloleucel) Although this is not directly affecting Mesothelioma yet, we believe there is hope. Yescarta is the newest treatment for adult patients with certain types of large B- cell lymphomas whose first line treatments have failed, or relapsed. This is the second gene therapy approved by the FDA. This approval came after a multicenter clinical trial of more than 100 adults who had relapsed or did not respond to initial treatment for large B cell lymphoma.
Yescarta is an immunotherapy that engineers a patient’s T cells to target the protein that expresses cancerous B cells. Once it targets the cancerous cell the objective is to eliminate them. This approval is based on a clinical trial phase 2 ZUMA-1 in which 101 patients participated who had been diagnosed with non-Hodgkin’s lymphoma. A large number, roughly 82% of the patients responded to this treatment. Most encouraging is that 54% of their tumors disappeared completely after treatment. Roughly 30,000 people are diagnosed each year in the United States. Three out of five patients have lymphoma B cell type. Often patients do not respond to treatment or relapse shortly after transplant.
The FDA commissioner stated,” Today marks another milestone in the development of a whole new scientific paradigm for the treatment of serious diseases.” Many years ago, gene therapy was a hope and today it is now a promising concept to treating deadly cancers. In 12 months, the expectation is that there will be 70-90 centers offering this treatment.
The cost of the drug is very expensive, $373,000 per patient. Although pricey, this has offered patients who have not responded to therapy or had a relapse and believed they were out of options, one more hope.
Every drug that is on the market for care of patients once was in a clinical trial. Many patients become involved with clinical trials because they have no more options. Clinical trials offer the chance to try medications that are not available to the public. Also, some patients have a desire to help future cancer patients. Whatever the reason you choose to become involved- patients receive the highest standard of care. Today we thank the patients who have become involved with clinical trials. As Winston Churchill stated , “Success is not final, failure is not fatal, it is the courage to continue that counts.”