EMA’s CHMP recommends conditional approval for Kite Pharma’s CAR T therapy for mantle cell lymphoma

pharmafile | October 20, 2020 | News story | Manufacturing and Production, Sales and Marketing CAR T, CAR-T, CHMP, EMA, kite pharma, lymphoma 

Kite Pharma’s anti-CD19 chimeric antigen receptor (CAR) T cell therapy known as KTE-X19 has received positive recommendation from the EMA’s Committee for Medicinal Products for Human Use (CHMP) as a treatment for relapsed or refractory mantle cell lymphoma in adults who have already received at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.

Like other CAR T therapies, KTE-X19 is manufactured from the patient’s own immune system cells. The positive backing of the drug was based on data generated by an ongoing Phase 2 study of 74 relapsed or refractory mantle cell lymphoma patients who had already been treated with anthracycline- or bendamustine-containing chemotherapy, as well as an anti-CD20 antibody therapy and a BTK inhibitor.

The findings have so far been promising in an area of unmet need, but the CHMP review found that further data would be needed to justify backing a full approval. The panel therefore recommended that the therapy be awarded a conditional approval, meaning it would be made available to patients on the condition that Kite generate and submit further data to allow the EMA to more accurately assess its efficacy.

Dr Ken Takeshita, Kite’s Global Head of Clinical Development, said the CHMP opinion was “an important milestone for patients in Europe living with relapsed or refractory mantle cell lymphoma.”  

The European Commission will now review the endorsement and make a final decision within the next few months.

Matt Fellows

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