Today, Gilead Sciences (NASDAQ:GILD) disclosed its next cell-based cancer therapy could become available this summer. The Food and Drug Administration recently granted a priority review to an application Gilead submitted a couple of months ago for KTE-X19 with an expected action date of Aug. 10, 2019.
Not exactly new
Gilead's potential new cancer therapy isn't exactly new. It's basically Yescarta with an improved manufacturing process that the company has aimed at a small segment of non-Hodgkin lymphoma patients. Yescarta and KTE-X19 are both CAR-T therapies made with cells harvested from patients that are trained to recognize cells with the CD19 antigen on their surface.
To get its hands on Yescarta and a handful of experimental CAR-T therapies in development, Gilead Sciences acquired Kite Pharma in 2017 for $11.9 billion.
Since a new batch of Yescarta and KTE-X19 must be manufactured for every patient, many of whom need to begin a new treatment regimen immediately, improvements to the process can have a big effect. This appears to be the case with KTE-X19 and mantle cell lymphoma patients that have exhausted additional treatment options. During a study supporting Gilead's application, a single infusion of KTE-X19 helped 67% of patients achieve complete remission.
The FDA recently approved a Bruton's tyrosine kinase (BTK) inhibitor called Brukinsa from Beigene (NASDAQ:BGNE) for the treatment of mantle cell lymphoma patients who have relapsed at least once. Brukinsa itself is up against Imbruvica which has been in the second line position for mantle cell lymphoma patients since 2013.
Since just 6% of patients with non-Hodgkin lymphomas are diagnosed with the mantle cell variety, this space looks like it could get crowded fast. Sales of Gilead's new therapy will probably remain limited to a very small audience that has already exhausted all available treatment options.