Kite On Course For FDA Filing On Positive CAR-T Durability Data

01 Mar 2017

• By Sukaina Virji

Kite Pharma is looking stronger than ever in the race to get a CAR-T product onto the market following positive topline results from a primary six-month analysis for KTE-C19 in aggressive NHL (ZUMA-1).

Data from the pivotal Phase I/II ZUMA-1 trial of Kite Pharma Inc.'s CAR-T cell therapy KTE-C19 in patients with aggressive non-Hodgkin’s Lymphoma will support a rolling BLA submission due shortly and a regulatory filing in Europe later this year.

The latest data showed that responses achieved in patients treated with KTE-C19 at the three-month mark remained durable at six months

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

Start your 7-day free trial
Explore trusted news, analysis, and insights
Access comprehensive global coverage
Enjoy instant access – no credit card required

Start Free Trial

Already a subscriber?

Most Favored Nation Policy ‘Lazy, Misguided,’ But US Price Reforms Politically ‘Inevitable’

15 May 2025

• By Cathy Kelly

Policy experts and pharma executives react to President Trump’s executive order on “equalizing” drug prices between the US and comparable nations at the ISPOR 2025 conference.