FDA Approves Second CAR-T Therapy in US to Gilead’s Kite Pharma
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The US Food and Drug Administration (FDA) has approved Yescarta (axicabtagene ciloleucel), a chimeric antigen receptor T cell (CAR-T) therapy, from Kite Pharma, a Santa Monica, California-headquartered cell therapy company and a subsidiary of Gilead Sciences. The approval was for treating adult patients with certain types of large B-cell lymphoma. Yescarta is the second CART-T therapy approved by the FDA and is slated by some analysts for blockbuster status.

Yescarta is a customized treatment created using a patient’s own immune system to help fight lymphoma. The patient’s T-cells, a type of white blood cell, are collected and genetically modified to include a new gene that targets and kills the lymphoma cells, according to the FDA. Once the cells are modified, they are infused back into the patient. The drug will be manufactured for each patient in Kite’s commercial manufacturing facility in El Segundo, California.

Yescarta is approved for use in adult patients with large B-cell lymphoma after at least two other kinds of treatment failed, including diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

In August 2017, the FDA approved Novartis’ Kymriah (tisagenlecleucel) as the first CAR-T therapy available in the US. The approval was for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia. Novartis plans additional filings for Kymriah in the US and European Union (EU) later in 2017, including applications with the FDA and European Medicines Agency, for treating adult patients with relapsed/refractory diffuse large B-cell lymphoma.

The FDA said in a statement that it plans to address its role in the advancement of cell therapies. “We will soon release a comprehensive policy to address how we plan to support the development of cell-based regenerative medicine,” said FDA Commissioner Scott Gottlieb, in an agency statement. “That policy will also clarify how we will apply our expedited programs to breakthrough products that use CAR-T cells and other gene therapies. We remain committed to supporting the efficient development of safe and effective treatments that leverage these new scientific platforms.”

In October 2017, Gilead Sciences completed its acquisition of Kite Pharma for approximately $11.9 billion. The deal was first announced in August 2017. As a result of the completion of the merger, Kite has become a wholly owned subsidiary of Gilead.

Source: FDA and Gilead Sciences

 

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