- Gilead can manufacture supplies of its cancer cell therapy Yescarta from a new factory in Maryland, after the Food and Drug Administration cleared the facility for commercial production of the personalized treatment.
- Regulatory approval of the site, located near Baltimore and Washington, D.C., will help increase Gilead's manufacturing capacity by 50%, the company said in a Tuesday statement. Gilead also uses facilities in California and the Netherlands to make Yescarta and its other cell therapies.
- Gilead began building the Maryland factory in 2019, about a year and a half after it acquired Yescarta's developer, Kite Pharma, for $12 billion. The 275,000-square-foot site will employ more than 400 staff by the end of the this year, Gilead said.
First approved in 2017 for lymphoma, Yescarta was cleared by the FDA for wider use earlier this month, making the regulator's clearance of the factory a timely boost to Gilead's manufacturing capacity.
With the most recent OK, Yescarta can now be used earlier for lymphoma patients who either relapse or see their disease become resistant to initial treatment. Previously, Yescarta's approval was limited to "third-line" treatment, after other therapies and, typically, a stem cell transplant had failed to curb patients' cancer.
The type of lymphoma Yescarta treats is the most common form of the blood cancer, with about 18,000 people diagnosed each year. Gilead estimates about 30% to 40% of those malignancies recur or develop resistance to early treatment.
Making Yescarta for those patients is a complex and laborious process, however. Immune cells are extracted from each patient and shipped to a Gilead manufacturing facility, where they are genetically modified to better seek out lymphoma. The souped-up cells are then shipped back to each patient and reinfused. Currently, the process, from cell extraction to finished product, takes Gilead about 16 days.
Having additional manufacturing facilities not only expands Gilead's production capacity, but also potentially shortens the transportation journey for patient cells on the way to and from the factory. The company's site in California is located near Los Angeles' main airport, while the new factory in Maryland is near airports in Baltimore and Washington D.C.
In the U.S., there are about 110 hospitals authorized to carry out treatment with Yescarta, with many located on the East Coast.
Gilead claims it has a 96% success rate in producing its cell therapies on time and within manufacturing specification — something its main rival in cell therapy, Novartis, has struggled with in the past.
Yescarta is the first so-called CAR-T cell therapy to be approved for second-line treatment of lymphoma. Bristol Myers Squibb, which sells the competing therapy Breyanzi, is currently awaiting an FDA decision on approval for the same indication. Its manufacturing turnaround time, at least as of Breyanzi's initial clearance last year, is slightly longer than Gilead's, at 24 days.
Novartis sells its CAR-T therapy Kymriah for late-stage treatment of lymphoma, but a study testing the drug in the second-line setting unexpectedly failed, forcing the company to prioritize a successor treatment that's not yet approved.
Clarification: This story has been updated to further specify the number of hospitals certified in the U.S. to conduct CAR-T treatment.