Friday, 17 November, 2017

United States approves gene therapy for cancer from Israeli-founded company

Gilead Cell-Therapy Drug Yescarta Gets FDA Approval FDA Approves Gilead CAR-T Therapy Yescarta, Plans Regenerative Medicine Policy 'Soon'
Marlene Weaver | 19 October, 2017, 18:57

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.

In August, the FDA approved a different CAR-T treatment for B-cell acute lymphoblastic leukemia in patients under the age of 25 who have not been helped by other treatments.

"Today marks another milestone in the development of a whole new scientific paradigm for the treatment of serious diseases", said FDA Commissioner Scott Gottlieb.

'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. DLBCL is the most common National Hockey League in adults and represents 1 in 3 new cases, according to the FDA. The indication includes 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).

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".

United States regulators have approved a second form of gene therapy to fight cancer. "We must also recognize the FDA for their ability to embrace and support transformational new technologies that treat life-threatening illnesses".

Each dose of Yescarta is a customized treatment created using a patient's own immune system to help fight the lymphoma.

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Both the new therapies are known as CAR-Ts or chimeric antigen receptor T-cell, which reprograms the immune cells in the body to recognized then attack all malignant cells.

Kite's therapy is for patients with three types of aggressive, or fast-growing, large B-cell lymphoma. "The approval of Yescarta brings this innovative class of CAR-T cell therapies to an additional group of cancer patients with few other options - those adults with certain types of lymphoma that have not responded to previous treatments", said Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research.

The FDA approval is based on a multicenter clinical trial of more than 100 patients. In Kite's pivotal study, 72% of patients responded and 51% achieved complete remission during the median follow-up period of about 8 months.

CAR-T treatments have raised concerns about side effects, most notably a unsafe immune response called cytokine release syndrome. Serious adverse reactions occurred in 52% of patients and included CRS, neurologic toxicity, prolonged cytopenias (including neutropenia, thrombocytopenia, and anemia), and serious infections.

The new treatment, Yescarta (axicabtagene ciloleucel), is for a kind of blood cancer called large B-cell lymphoma. It's none other than death: according to The WSJ, Kite Pharma determined that the deaths of two of its test subjects were related to the treatment.

"The FDA is requiring that hospitals and their associated clinics that dispense Yescarta be specially certified".

Yescarta's headline price raised eyebrows when announced yesterday, as its substantially undercuts the $475,000 charged by Novartis for its first-to-market CAR-T, Kymriah.

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