Gilead And Novartis Unveil EU Marketing Plans For CAR-T Therapies, But Hurdles Remain

Building manufacturing capacity, educating physicians, and reaching agreements with pricing and reimbursement bodies are just some of the hurdles CAR-T therapies have to jump over in Europe, following their approval by the EU Commission earlier this week.

Hurdles
Pricing and reimbursement has to be agreed country-by-country in Europe • Source: Shutterstock

The two just-approved CAR-T therapies in Europe may find it tough going to maximize their market opportunity. One of the novel products, Novartis AG's Kymriah (tisagenlecleucel), will only be launched initially in one of its indications. The other, Gilead Sciences Inc.'s Yescarta (axicabtagene ciloleucel), has been rejected by the continent's leading health technology assessment body, the UK's National Institute for health and Care Excellence (NICE), in draft guidance released on Aug. 28.

Kymriah is indicated in the EU for the treatment of pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse, as well as for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Yescarta is indicated in the EU for the treatment of adult patients with relapsed or refractory DLBCL and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy. Approval of both therapies by the EU Commission were announced Aug

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