- 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.
The CAR-T space had lost some of its luster after the Food and Drug Administration temporarily halted Juno Therapeutics "ROCKET" trial after three patient deaths and Novartis disbanded its dedicated cell therapy unit.
But Kite is driving hard towards winning U.S. approval of KTE-C19, which would be the first CAR-T on the market if okayed by the FDA.
"We are very pleased with the outcome from our productive discussions with the FDA and their willingness to partner with us to advance this innovative therapy," said Kite CEO Arie Belldegrun. "We will focus on initiating and finalizing the submission based on the FDA feedback and look ahead to the potential approval of KTE-C19 in 2017."
If KTE-C19 does clear FDA review, Kite would enjoy a first-to-market competitive advantage in CAR-T, although it is not clear how much this would be worth given the early-stage nature of the class. Jefferies, an investment firm, predicts a completed Q1 filing would yield a November 2017 PDUFA date and has adjusted its 2017 sales estimate to $9.1 million.
Kite is planning further expansion studies in six additional B-cell malignancies, recently beginning enrollment in a Phase 1b/2 study combining KTE-C19 and Roche's checkpoint inhibitor tecentriq (atezolizumab) — the first such combination study.
The company's T-cell receptor (TCR) and CAR-T development pipeline has also grown, with four new INDs planned between 2016 and 2018.