LucidQuest Strategic Insights (lqventures.com) >>> Gene&Cell Therapy >> Gilead, Kite shorten Yescarta manufacturing by two days in
'incremental' improvement: Gilead and Kite announced Tuesday it received FDA approval to shorten its manufacturing process for the cell therapy Yescarta, a move expected to reduce the time patients need to wait for the treatment by two days.
The shortening, measured by what’s known as “median turnaround time (TAT),” will fall from 16 days to 14 days, Gilead estimates. David Porter, the director of cell therapy and transplants at Penn Medicine, told Endpoints News any improvement in median TAT is good, but Tuesday’s update represents one that is “incremental.”
“It is important to get patients their cells back as soon as possible,” Porter said. “Now, does a difference between 16 days and 14 days make a big difference? I would tell you that’s not likely to be clinically significant.
“Any time is good,” he added. “You don’t want to give the cancer time to grow. But shortening from 16 days to 14 days probably is not that major of an advance.”
The 14-day process encompasses collection of patients’ cells, the manufacturing of genetically re-engineered cells and testing to ensure the new cells work. Previously at #ASH23, Gilead and Kite executives had told Endpoints they were working on reducing the manufacturing and re-engineering component from seven days to five days.
Chris McDonald
Chris McDonald, Kite’s global head of technical operations, said in an interview last week that the companies had figured out how to “optimize” that manufacturing process and cut it by two days. The move should reduce the overall costs and increase the manufacturing capacity at their two US plants in California and Maryland.
“We’re essentially reducing the manufacturing time by two days, which is going to reduce some of our quality control testing and some of the processing steps,” McDonald said.
The specifics of what is being optimized will remain a secret, he added, noting Gilead and Kite want to maintain their “competitive intelligence.” This improvement will also take more time to be implemented outside the US, as additional regulatory approvals will be needed.
McDonald noted this update is solely for Yescarta and not the pair’s other approved cell therapy, Tecartus.
Gilead already had the fastest turnaround times for its two cell therapies before Tuesday, with Yescarta taking a median 16 days and Tecartus needing 15 days. Bristol Myers Squibb, the manufacturer of Abecma and Breyanzi, can produce the treatments in “less than 30 days,” according to a spokesperson.
Asked about the turnaround time for Johnson & Johnson’s Carvykti, a spokesperson pointed to the treatment’s marketing website, which described the re-engineering process as four to five weeks long. And regarding Novartis’ cell therapy… #lucidquest #genetherapy #celltherapy
