Kite Pharmaceuticals Submits Application for New Lymphoma Therapy
Kite Pharmaceuticals has officially requested marketing authorization of its new CAR T-cell therapy via an MAA (marketing authorization application) to the European Medicines Agency (EMA). Their axicabtagene ciloleucel therapy is the first chimeric antigen receptor (CAR) T-cell therapy to ever be submitted to the EMA.
Kite Pharmaceuticals has officially submitted its new CAR-T cell therapy to the European medicines agency through the marketing authorization application. The first chimeric antigen receptor T-cell therapy, their axicabtagene ciloleucel therapy is to be reviewed before the EMA for approval.
Kite Pharmaceuticals is based in Santa Monica, California. It is a biopharmaceutical company that is leading in cell therapy. The creation of innovative cancer immunotherapy is their main focus. The chimeric antigen receptor that Kite is involved in is meant to enable the immune system to locate the cancer tumors and kill them. Down the line, the need for other therapies would be eliminated if this ends up being successful.
Kite’s investigational therapy is axicabtagene ciloleucel. It is referred to formally as KTE-C19. This therapy targets patients with leukemia and other forms of lymphoma. Some lymphoma patients have transformed follicular lymphoma, refractory or elapsed diffuse large B cell lymphoma, or primary mediastinal B cell lymphoma, but are unable to receive autologous stem cell transplants. In order to modify the patients pre-existing T cells, a CAR T-cell therapy amasses them. To depict a CAR protein, the patient’s T cells are transformed in this modification. Thus, molecule CD 19 is seen in B cell lymphomas and leukemia’s.
Although it has yet to be determined what will happen to the company’s application, the FDA has already approved the therapy for the treatment of DLBCL, TFL, and PMBCL. From the European Union, it has attained PRIME status. The support of the FDA and the European Union will act as a catalyst for its regulatory review and will support its development. Kite’s pharmaceutical biologics license application is still being reviewed for the treatment of refractory aggressive non-Hodgkin’s lymphoma. As per the Prescription Drug User Fee act, the USFDA will release their results and final decision by November 29. So, by the end of November, more information will be available on axicabtagene ciloleucel.
Every year, around 93,000 people in Europe suffer from NHL, and its subtypes also grow quickly. After the first treatment, many patients experience remission, then relapse and do not respond well to the preliminary treatments. The outcome for such patients is unfortunately grim. Kite Pharmaceuticals stated that their CAR-T therapy will aid an estimated 7,800 people in the European Union alone.
A competitor to this is Novartis, which is also developing a CAR-T therapy. They are scheduled to make their product available on the market before Kite’s. Also, they have won unanimous backing from the FDA panel. Their application differs from Kite’s. The company’s CEO is working towards fair pricing that would allow people to better afford axicabtagene ciloleucel. So, Novartis has called fair pricing activists to help develop a fair cost, although it is difficult since the drugs are expensive.
Since the CAR-T therapy is so innovative, it could be very profitable for its corresponding pharmaceutical company, Gilead. It is already known that the taxpayers funded the research, so attempting to price it too high could lead to significant backlash.