Kite’s Yescarta to receive European marketing authorisation

First treatment in 30 years to improve second-line treatment of DLBCL

Kite – a Gilead Company – has announced that the European Commission (EC) has granted approval for the use of Yescarta, also known as axicabtagene ciloleucel, for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL).

It also involves patients who relapse within 12 months from completion of first-line chemoimmunotherapy. The approval is based on results from the pivotal phase 3 ZUMA-7 study – the largest and longest trial of a CAR T-cell therapy versus standard of care in this patient population.

Axicabtagene ciloleucel is now the first Chimeric Antigen Receptor (CAR) T-cell therapy approved for patients in Europe who do not respond to first-line treatment. This provides an important additional treatment option for the most common form of non-Hodgkin lymphoma. Although 60% of newly diagnosed LBCL patients, including those with DLBCL, will respond to their initial treatment, 40% will relapse or will not respond and need second-line treatment

“We are very proud to announce Kite’s fifth approved indication in Europe in our continued commitment to the research and delivery of cell therapies with curative potential to patients who might benefit around the world,” explained Christi Shaw, chief executive officer at Kite. “Today’s approval marks an important step towards that goal by providing patients in Europe this option of CAR T-cell therapy earlier in their treatment journey.”

“This approval marks a major shift in the treatment of LBCL when initial treatment has failed. In ZUMA-7, treatment with axicabtagene ciloleucel resulted in an overall better outcome for patients than standard of care, especially in terms of event-free survival, marking a new era for treatment earlier in the disease pathway for more patients,” said Professor John Gribben, professor of medical oncology at the Cancer Research UK Barts Centre.

“The ZUMA-7 data has also broadened our understanding of this CAR T-cell therapy, allowing us to better manage or prevent side-effects, which is important as it moves earlier in the treatment pathway and for older patients and those with medical conditions for whom the standard of care might have been difficult,” he added.

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