Kite Pharma's Yescarta (axicabtagene ciloleucel), marking the second gene therapy approved in the United States and the first for certain types of non-Hodgkin lymphoma. Each treatment of the T-cell therapy is customized using a patient's own immune cells, starting with T cells collection via apheresis, shipment to a manufacturing facility, and genetic modification of the cells to express a auto specific to CD19, which is commonly over-expressed in B cell malignancies allowing the modified immune cell to target and kill the lymphoma cell.
Returned to the patient, all the revved-up cells can continue multiplying to fight disease for months or years.
"Engineered cell therapies like Yescarta represent the potential for a changing treatment paradigm for cancer patients", said David Chang, MD, PhD, worldwide head of research and development and chief medical officer at Kite, in a company press release. The FDA has linked a risk evaluation and mitigation strategy with the approval: hospitals and their associated clinics that dispense axicabtagene ciloleucel need to be specially certified.
Yescarta is the second CAR-T treatment approved by the FDA. Dr. Locke helped run patient tests of Yescarta.
The second auto T-cell therapy approved by the FDA targets a type of lymphoma with a grim prognosis, offering new hope to patients who have often relapsed after a string of earlier treatments.
Gilead's new approval is also for a broader patient population than the Novartis drug Kymriah.
In a pivotal clinical trial of more than 100 adults, 51 percent of patients treated with Yescarta achieved complete remission, far higher than what is typical with current standard-of-care treatments.
"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", he added. The therapy was approved for treating certain types of large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma (transformed follicular lymphoma).
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To start, a doctor removes some white blood cells, the part of our body's immune system responsible for combatting infections and foreign substances, from a patient.
For more on what role pharmacists can play for patients with lymphoma, view the video below.
Dr. Arie Belldegrun, founder of Kite, recognized "the FDA for their ability to embrace and support transformational new technologies that treat life-threatening illnesses".
The CAR T-cell therapy was approved with a boxed warning regarding CRS.
Noting the FDA's commitment to "supporting and helping expedite" the development of gene therapies, Gottlieb said, "we will soon release a comprehensive policy to address how we plan to support the development of cell-based regenerative medicine".
Almgren said the approval of Yescarta is "certainly very exciting".
"I believe this treatment approach brings hope to many patients, but one thing to consider is cost", said Almgren.
The FDA decision opens the door for a new gene therapy to treat adults with aggressive lymphoma, noted Maloney.