Please login to the form below

Not currently logged in

EMA begins review of Kite’s CAR-T for mantle cell lymphoma

If approved will become first CAR-T therapy for MCL

Kite Pharma

The European Medicines Agency (EMA) has begun its review of Gilead subsidiary Kite’s next-generation CAR-T therapy KTE-X19. 

Kite is seeking approval for the CAR-T therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) – according to the company, if KTE-X19 is approved it will become the first CAR-T for this indication.

The marketing application was supported by data from the phase 2 ZUMA-2 trial, which demonstrated an overall response rate in the patient population of 93%, including 67% with complete response.

“Relapse rates in mantle cell lymphoma remain overwhelmingly high and there is a significant need for new therapies that may improve patients’ prognosis,” said Ken Takeshita, Kite’s global head of clinical development.

“The EMA validation of our marketing application brings us closer to delivering on the promise of our industry-leading cell therapy development program, with the hope that we can bring KTE-X19 to appropriate patients in Europe as quickly as possible,” he added.

Gilead/Kite already have one approved CAR-T therapy in the arsenal – Yescarta (axicabtagene ciloleucel) – which is approved for diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma.

Current treatment options for MCL include AstraZeneca’s BTK inhibitor Calquence (acalabrutinib) and Johnson & Johnson/AbbVie’s BTK inhibitor Imbruvica (ibrutinib).

CAR-T therapies work differently to these drugs – in CAR-T therapies, patients’ cells are harvested and modified so they are more likely to seek out and destroy cancer cells expressing a particular antigen. Once reprogrammed, the T cells are infused back into the patient in order to fight the cancer.

The first CAR-T therapy to be approved was Novartis’ Kymriah back in August 2017, with Yescarta following a few months later, gaining approval in October.

Uptake of CAR-T therapies can prove difficult, as companies face significant challenges in manufacturing these treatments, a process which requires patients’ own T cells to be extracted and genetically modified, and eventually re-infused back into the patient.

Both Kymriah and Yescarta are available on for use on the NHS in England, with the health service quickly recommending these treatments – which NHS England chief executive Simon Stevens hailed as “revolutionary”.

Kite also submitted a biologics license application for KTE-X19 to the US Food and Drug Administration (FDA) on 11 December for the same indication.

Article by
Lucy Parsons

29th January 2020

From: Regulatory



COVID-19 Updates and Daily News

Featured jobs


Add my company

About Dovetail We’re award-winning specialists in healthcare collaboration that makes patients’ lives better. Combining expertise with a passion for collaboration,...

Latest intelligence

Virtual Engagement At Porterhouse: Reflections on the past few months
A look at how the pitfalls of virtual engagement can be avoided and the key advantages of virtual client and KOL engagement strategies in a now predominantly digital world....
July 2020: diversity and inclusion in clinical trials round-up
COVID-19 has continued to bring diversity and health inequality to the forefront of people’s attention. Our latest round-up covers the July news around these issues, and brings you the latest...
Medical Device Clinical Trials 2020
In July 2020, we attended and exhibited at the Medical Device Clinical Trials 2020 Virtual Experience. We really enjoyed the day and it was great to hear from like-minded people,...