As Novartis awaits a final FDA ruling on its CAR-T therapy, Santa Monica, California-based Kite Pharma has jumped the Atlantic to file the first Marketing Authorization Application (MAA) with the European Medicines Agency (EMA).
Announced Monday, the MAA centers around axicabtagene ciloleucel (axi-cel), a chimeric antigen receptor (CAR) T-cell therapy that targets CD19, a protein expressed on the surface of the B-cells that drive lymphomas and leukemias.
Axi-cel is being pitched as a potential treatment for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) who are ineligible for autologous stem cell transplants. It also has a biologics submission filed with FDA, though it is several months behind Novartis.
While it seems inevitable that one of the CAR-T therapies will soon reach the market, many question marks remain around the post-marking logistics — domestically and internationally.
Kite unveiled an early outline for manufacturing and distribution of the therapy at the J.P. Morgan Healthcare Conference in January. The company has reportedly constructed a manufacturing facility in El Segundo, California, in close proximity to the Los Angeles International Airport (LAX). T-cells harvested from patients throughout the U.S. would be flown there for engineering, before being sent back to the patient’s local clinic for reinfusion.
According to E.P. Vantage’s Jacob Plieth, the El Segundo facility would also service Europe.
— Jacob Plieth (@JacobPlieth) July 31, 2017
The aim is to eventually treat 4-5,000 patients per year, starting with axi-cel, Kite CEO Arie Belldegrun told the conference crowd.
While the “race” to the market has received ample attention, most agree there is more than enough room for multiple CAR-T therapies, with plenty of receptors and indications to target. Indeed, the companies have publicly supported each others’ efforts.
“I will be Novartis’ biggest cheerleader today,” Belldegrun wrote in a blog post about FDA’s advisory committee meeting in July. “Kite and Novartis have consistently been positioned as competitors, and I am amused by the horse-race metaphors that are used to frame the various companies developing CAR-T therapies. Today is not about business or competition. Today, we are not rivals. Today is about advancing an exciting technology that has the potential to transform cancer treatment.”
Kite may be the first to submit a CAR-T therapy to the EMA and it may well be one of the last to send the application to London. Following Brexit, the headquarters of the EMA will move from the United Kingdom to somewhere in continental Europe. Milan, Amsterdam, Barcelona, Copenhagen, Dublin, Lille, Lisbon, Stockholm, and Bratislava are all vying for hosting rights, according to a recent commentary published in the Lancet. The window for applications closed on Monday; a decision will be made later this year.
Photo: DANIEL LEAL-OLIVAS, AFP/Getty Images