Kite first to file for CAR-T approval in Europe
- Kite Pharma, Inc. likely won't be the first to secure U.S. approval for a CAR-T cell therapy. But it stands a good chance of winning the honor in Europe, where on Monday the California biotech filed for marketing authorization for its blood cancer treatment axicabtagene ciloleucel.
- The European Medicines Agency (EMA) granted Kite's CAR-T accelerated assessment under its PRIME designation — a regulatory process akin to the Food and Drug Administrations Priority Review program.
- Kite submitted axicabtagene ciloleucel for use in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) or two other types of non-Hodgkin lymphoma (NHL) who are ineligible for stem cell transplantation.
The past 12 months have seen rapid progress from both Kite and its Swiss rival Novartis AG, advancing CAR-T therapy to the brink of regulatory approvals in the U.S. and Europe.
Kite first began a rolling submission to the FDA for axicabtagene ciloleucel in NHL last December. After accumulating six months of follow-up date from its ZUMA-1 study, Kite completed its Biologics License Application and received a priority review nod from the FDA in May.
That sped-up review set up a target decision date on approval of November 29, 2017. In preparation of an expected approval, Kite has ramped up its manufacturing capabilities and laid out launch plans as it readies for commercial production.
In the U.S., though, Novartis looks set to win the first CAR-T approval before Kite, barring any surprises. An advisory expert panel unanimously recommended an OK for the pharma's tisagenlecleucel in relapsed/refractory pediatric or young adult acute lymphoblastic leukemia (ALL) last month. ALL is considered a smaller indication than DLBCL.
Novartis had submitted its application in March and received priority review status — meaning a decision from the FDA should come around the end of September.
U.S. and EU submissions for tisagenlecleucel in DLBCL are planned for the fourth quarter, potentially setting up direct competition with Kite. A filing in Europe for the ALL indication is also expected sometime in the second half of the year.
- Kite Pharma Press release
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