FDA approves J&J’s myeloma cell therapy

The US FDA has approved a CAR-T therapy developed by Johnson & Johnson and its partner Legend Biotech to treat white blood cell cancer.

J&J division Janssen Biotech entered the cell and gene therapy space in 2017, teaming up with Legend Biotech for the development of Carvykti ( ciltacabtagene autoleucel; ciltacel), a chimeric antigen receptor T-cell (CAR-T) therapy that specifically targets the B-cell maturation antigen (BCMA) and is known as LCAR-B38M in China.

Now, the US Food and Drug Administration (FDA) has granted authorization for Carvykti making it the first approved product to treat adults with relapsed or refractory multiple myeloma (RRMM) who have received four or more prior lines of treatment, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

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“The FDA approval of Carvykti marks the first approved cell therapy for Janssen, a testament to our continuing commitment in oncology to deliver new therapeutic options and drive toward our vision of the elimination of cancer,” a spokesperson for J&J told BioProcess Insider.

Pivotal study

J&J dubbed the CARTITUDE-1 study as “pivotal” with 98 percent of patients with RRMM responding to one-time treatment with ciltacabtagene autoleucel. Additionally, 78 percent of the patients reaching this level of response experienced a stringent complete response.

“Cell therapy is an area of continued focus and innovation for Janssen as we look to continue to deliver innovations for patients facing a cancer diagnosis. With our strong commitment and deep expertise in multiple myeloma, we believe we are uniquely positioned to change the treatment paradigm and one day deliver a cure for this disease,” the spokesperson said.

Carvykti is only available through a restricted program under Risk Evaluation and Mitigation Strategy (REMS) named the Carvykti REMS Program. J&J and Legend claims that administration of Carvykti requires extensive training, preparation, and certification to “ensure a seamless experience for patients.”

Together, through a phased approach, the companies will initiate a network of treatment centers as they work to scale production capacity and up the availability of Carvykti throughout the US this year and beyond.