Months after Novartis and Gilead Sciences won their CAR-T approvals in the U.S., the companies have scored CHMP recommendations for Kymriah and Yescarta in Europe.
The European Medicines Agency's Committee for Medicinal Products for Human Use endorsed the drugs on Friday, sending the recommendations to the European Commission for a final determination on marketing approval.
CHMP recommended Kymriah to treat acute lymphoblastic leukemia (ALL) and diffuse large B-cell lymphoma (DLBCL). The experts signed off on Gilead's Yescarta to treat DLBCL and primary mediastinal B-cell lymphoma, potentially setting up direct competition between the drugmakers in the DLBCL space.
After European approvals, companies marketing new drugs enter negotiations with authorities in individual countries to decide pricing and reimbursement. Those negotiations have created issues for new drug launches in the past as cost watchdogs tried to secure favorable pricing, sometimes by blocking access.
Already in the U.S., both medications carry approvals to treat relapsed or refractory large B-cell lymphoma, including DLBCL. Novartis' Kymriah also carries the ALL indication. Novartis won the world's first CAR-T drug approval last August.
The drugs provide a potential cure for patients who previously had few or no options but carry expensive price tags and logistical complexities. In the U.S., Novartis priced its drug at $475,000 in pediatric ALL and $373,000 in adult DLBCL; Gilead's Yescarta costs $373,000. CAR-T medications are one-time treatments intended to cure a patient's disease.
One reason they are so expensive is their unique, patient-specific manufacturing. CAR-T drugs are made of re-engineered T cells collected from each patient, which are then infused back into the patient to attack cancer.
To prepare for the European rollout, Gilead recently announced that it's building a CAR-T manufacturing plant at the Amsterdam airport in an effort to cut down on logistics and manufacturing turnaround time. The center will have 300 employees when fully operational, expected in 2020. Novartis, for its part, has an agreement with the Fraunhofer Institute for Cell Therapy and Immunology to process cells in Europe.
Despite the high price tags, U.S. cost-effectiveness group ICER said the medications "seem to be priced in alignment with clinical benefits over a lifetime time horizon."
Gilead entered CAR-T through last year's $11.9 billion deal to buy Kite Pharma.