KITE RECEIVES EUROPEAN MEDICINES AGENCY APPROVAL OF SAFETY MONITORING VARIATION FOR CAR T-CELL THERAPY PORTFOLIO

-- In-Hospital Patient Monitoring for Adverse Events Reduced from Ten to Seven Days Following CAR T-cell Therapy Infusion --

Stockley Park, UK – 6 June 2024 – Kite, a Gilead Company, today announced that the European Medicines Agency has approved a Type II variation to the Summary of Product Characteristics (SmPC) for its approved Chimeric Antigen Receptor (CAR) T-cell therapies, Yescarta^® (axicabtagene ciloleucel) and Tecartus^® (brexucabtagene autoleucel). 

The variation includes a reduction in daily hospital safety monitoring for patients following CAR T-cell therapy infusion from ten to seven days, which was supported by further data from clinical trials, post-marketing studies, and updated peer-reviewed publications. The updated safety monitoring timelines apply across all approved indications for axicabtagene ciloleucel and brexucabtagene autoleucel in difficult-to-treat haematological cancers in adults.

“This approval is good news for patients, caregivers and physicians, and support capacity in healthcare systems for eligible patients,” said Dominique Tonelli, Executive Director, Head of Medical Affairs, ACE, Kite. “It reinforces the wealth of clinical and real-world evidence available for axicabtagene ciloleucel and brexucabtagene autoleucel, that supported this reduction in monitoring timelines, and enabling physician discretion in the subsequent management of their patients.”

A Type II variation is a change to the marketing authorisation of a treatment that may have a significant impact on the quality, safety or efficacy of a medicine, but does not involve a change to the active substance, its strength or the route of administration. Type II variations require formal approval by the European Medicines Agency. As with other approved CAR T-cell therapies, these products remain subject to additional safety monitoring.[i]

About Yescarta (Axicabtagene Ciloleucel)

Axicabtagene ciloleucel is a CD19-directed genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy, approved by the European Commission (EC) for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) who relapse within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy; adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B cell lymphoma (PMBCL), after two or more lines of systemic therapy; adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy.[ii]

About Tecartus (Brexucabtagene Autoleucel)

In December 2020, the EC granted conditional Marketing Authorisation for brexucabtagene autoleucel, the first CAR T-cell therapy approved in Europe for adult patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor. In August 2022, the EC approved brexucabtagene autoleucel for the treatment of adult patients 26 years of age and above with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia.[iii]

About Kite

Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, focused on cell therapy to treat and potentially cure cancer. As the global cell therapy leader, Kite has treated more patients with CAR T-cell therapy than any other company. Kite has the largest in-house cell therapy manufacturing network in the world, spanning process development, vector manufacturing, clinical trial supply and commercial product manufacturing.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.  Gilead acquired Kite in 2017. 

[i] European Medicines Agency. Type II Variation. Available at: https://www.ema.europa.eu/en/glossary/type-ii-variation#:~:text=A%20major%20change%20to%20a,variations%20require%20a%20formal%20approval. Accessed: May 2024.  

[ii] European Medicines Agency. Yescarta^® (axicabtagene ciloleucel) SPC. Available at: https://www.ema.europa.eu/documents/product-information/yescarta-epar-product-information_en.pdf. Accessed: May 2024.

[iii] European Medicines Agency. Tecartus^® (brexucabtagene autoleucel) SPC. Available at: https://www.ema.europa.eu/en/documents/product-information/tecartus-epar-product-information_en.pdf. Accessed May 2024.