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Manufacture Advanced Medicine

Cell Therapy 2.0

Back in 2012, a young girl named Emily Whitehead was discharged from hospital having entered complete remission from her life-threatening acute lymphoblastic leukaemia. Developed by Carl June and a crack team of scientists at the University of Pennsylvania, the treatment was made from Emily’s own T cells modified to attack the cancer. In the eight years since this groundbreaking result, progress for modified cell therapies has been steady. Two CAR T therapies have been approved by the FDA and other regulators, with a further three poised for approval – and many more showing great promise in the clinic (see Table 1). 

Following the approvals, investment piled into the sector. The result: 37 percent year-on-year growth in clinical trials (see Figure 1) to the point that the field now boasts well over 1000 trials across the globe. But after stunning early successes and billions of dollars of subsequent investment, there are still many unsolved challenges relating to the complexity of manipulating living cells. With issues from manufacturing and scalability to patient access and cost, the field is seeking approaches that boost the utility of modified cell therapies. 

CAR T and developer FDA/EMA approval status and disease indication Target Cell source
Tisagenlecleucel (Kymriah)

Novartis and University of Pennsylvania
August 2017: FDA approval for B-cell acute lymphoblastic leukaemia (ALL)

May 2018: FDA approval for B-cell lymphoma

August 2018: EMA approval for B-cell ALL and diffuse large B-cell lymphoma
CD19 Autologous
Axicabtagene ciloleucel (Yescarta)

Kite, a Gilead Company
October 2017: FDA approval for large B-cell lymphoma

August 2018: EMA approval for large B-cell lymphoma
CD19 Autologous
KTE-X19

Kite, a Gilead Company
December 2019: BLA submitted to FDA for mantle cell lymphoma

January 2020: MAA under evaluation by EMA for mantle cell lymphoma

February 2020: FDA grants priority review
CD19 Autologous
Lisocabtagene maraleucel

BMS
December 2019: BLA submitted to FDA for large B-cell lymphoma

February 2020: FDA grants priority review

May 2020: FDA extends action data by 3 months for BLA
CD19 Autologous
Idecabtagene vicleucel (Bb2121)

BMS & Bluebird Bio
March 2020: BLA submitted to FDA for multiple myeloma

May 2020: Received FDA Refusal to File letter and EMA validates MAA
BCMA Autologous

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About the Author

Pippa Gledhill

Senior Research Analyst at Beacon Targeted Therapies (www.beacon-intelligence.com)

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