Kite Pharma Inc, company under Gilead Sciences Inc. (NASDAQ: GILD)announced on Thursday that the U.S. Food and Drug Administration (FDA) has granted regular approval for its Yescarta (axicabtagene ciloleucel), the first CART-T therapy treatment for adult patients.
Gilead acquired Kite Pharma in August for $12 billion. Gilead previously mentioned in the statement of the acquisition that the merger would position Gilead to become a leader in cell therapy. The merger is not subject to close until the end of the fourth quarter of fiscal year 2017.
CAR-T therapy is a hematologic cancer treatment in which the patient’s own T cells are engineered to eliminate cancer cells. CAR-T therapy can be very expensive for patients as it's specifically manufactured differently for every patient.
Kite’s Yescarta is therapy treatment for adult patients who suffered relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. The complete remission rate after treatment with Yescarta was 51 percent.
“With CAR T therapy, we are reengineering a patient’s own immune system to detect and kill cancer cells, and the results have been impressive,” said Frederick L. Locke, MD, ZUMA-1 Co-Lead Investigator and Vice Chair of the Department of Blood and Marrow Transplant and Cellular Immunotherapy.
Diffuse large B-cell lymphoma (DLBCL) is the most common and aggressive non-Hodgkin lymphoma, a form of blood cancer, which accounts for every 3 in 5 cases. In the U.S. alone, there are nearly 7,500 patients affected by B-cell lymphoma by the cancer. But there are over 72,000 new cases annually of non-Hodgkin lymphoma cases.
Patients who suffer from this cancer usually have a median overall survival of approximately six months. Less than 10 percent of patients respond completely to other forms of therapy. Kite’s new therapy will be breakthrough in the cancer therapy industry.
“Today marks another milestone in the development of a whole new scientific paradigm for the treatment of serious diseases. In just several decades, gene therapy has gone from being a promising concept to a practical solution to deadly and largely untreatable forms of cancer,” said FDA Commissioner Scott Gottlieb, M.D.
The list price of Yescarta in the U.S. is $373,000.