Kite Pharma ($KITE) is looking to make the most of its recently extended lead in the CAR-T race. With Juno Therapeutics ($JUNO) slipping after its clinical hold, Kite is aiming to file for approval by the end of the year on the basis of data on 51 patients with three months of follow-up.
The numbers flesh out the details of what Kite will go to the FDA with if it achieves its long-held ambition of having a BLA with the regulator by the end of the year. Kite expects to have the results it needs for the submissions within the next few weeks, at which time it will decided whether the slim data set is sufficiently compelling to file with FDA. Barring any unexpected surprises, Kite thinks it will take a big step toward becoming the first company to win approval for a CAR-T in the coming months.
“Based on the feedback that we have received from the FDA, we are very much on track for submitting the BLA by year end,” Kite CMO David Chang said on a conference call with investors.
If Kite achieves this goal, it will position itself to win approval for KTE-C19 as a treatment for diffuse large B-cell lymphoma, primary mediastinal B cell lymphoma and transformed follicular lymphoma next year. With the brief clinical hold causing Juno’s targeted approval to slip from 2017 to 2018, Kite is positioned to come to market well before its rival, while also pipping Novartis ($NVS) to the post.
Having been handed this advantage, Kite is pushing hard to ensure nothing eats into its head start. Asked how soon after approval Kite would be ready to launch KTE-C19, Chief Commercial Officer Shawn Tomasello was unequivocal.
“Immediately. We’ll be ready,” Tomasello said.
To live up to Tomasello’s bullishness, Kite will need to have all its commercial and logistic units ready to go by some time next year. Work in these areas is already well underway. Tomasello is in the middle of building out a commercial team that will target 50 to 70 cancer centers.
The manufacturing team is further along. Approximately half of Kite’s 300 employees are involved in supply chain, quality assurance and other aspects of manufacturing, a proportion that reflects the fact that the efficiency of this side of the business will be critical to the company’s ability to deliver drug to patients while turning a profit.
- read the release
- here’s the call transcript
- and the 10-Q
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