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FDA Approves CAR T-cell Therapy for Adults with Lymphoma

Anna Maria Di Giorgio
Article - ISPE Pharmaceutical Engineering

Gilead Science’s 28 August purchase of Kite Pharma, Inc., one of the companies developing CAR T-cells, a therapy that harnesses the body’s own immune system to recognize and attack malignant cells, paid off in spades last week. On Wednesday, 18 October, the US Food and Drug Administration (FDA) approved Kite’s Yescarta (axicabtagene ciloleucel) for the treatment of adult patients witBreakthrough for Pharma Industr17h relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, 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).

The FDA approved Kymriah (tisagenlecleucel, CTL019), the Novartis CAR T-cell therapy for the treatment of pediatric and young-adult patients with relapsed and refractory B-cell acute lymphoblastic leukemia, on 30 August 2017.

Perhaps the most extraordinary medical treatment humankind has seen thus far, CAR T-cell therapy promises to transform both the pharmaceutical industry and patients’ lives. The price tags remain steep: $373,000 (Kite) and $475,000 (Novartis), as both therapies carry high manufacturing costs. Standard therapies, such as bone marrow transplants, are in a similar price range.

Kite Pharma filed a Marketing Authorization Application with the European Medicines Agency for axicabtagene ciloleucel in July 2017, the first CAR T-cell application in Europe. Potential approval is expected in the first half of 2018. Yescarta has received Priority Medicines regulatory support for DLBCL in the European Union.  

To learn more about this exciting new therapy, the patients it benefits, and the industry it seeks to transform, join us in San Francisco from 4 to 6 December at the ISPE 2017 Biopharmaceutical Manufacturing Conference, where Gilead and Kite will deliver the opening keynote address.

In addition to the cover story, check out the Special Report: Setting the Course for Biopharma's Future featuring the following articles: