- Kite Pharma said it had met with the Food and Drug Administration about a filing for approval of its lead CAR-T therapy KTE-C19, building a little more breathing room into its ambitious regulatory plans.
- The company will begin a rolling submission of its application by the end of December, with a targeted completion date set for the first quarter of 2017. If all goes according to plan, commercial-scale manufacturing is already in place and KTE-C19 could hit the market next year.
- Kite is targeting a broad label covering aggressive non-Hodgkin lymphoma, drawing on interim data from the ZUMA-1 trial. Results showed an complete response rate of 33% in chemorefractory DLBCL at three months post-treatment.
Catalyst
Slingshot members are tracking this event:
Kite Pharma (KITE) on Track to Potentially Launch and Commercialize KTE-C19 in Late 2017
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Additional Information
Slingshot Insights Explained
Catalyst Date
Occurred on:
Oct 18, 2017
Occurred Source:
https://www.drugs.com/newdrugs/fda-approves-yescarta-axicabtagene-ciloleucel-car-t-cell-therapy-adults-certain-types-large-b-cell-4615.html
Related Projects
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Related Keywords
Kte-c19, Commerical Launch
