Novartis, whose personalized CAR-T cancer treatment Kymriah won an approval in May to treat relapsed large B-cell lymphoma, said today it has run into some manufacturing issues around that condition.
Liz Barrett, CEO of Novartis Oncology, said during the company’s second-quarter earnings call that a majority of patients are getting their treatments and that the company is working closely with the FDA as it figures out how to resolve the issue.
“We have a perspective of what the issue is and we are continuing production and are able to provide the therapy to the majority of patients,” she explained.
The problem revolves around cell variability when treating DLBCL, Barrett said. She explained the label for commercial production is more stringent than in clinical trials for the percentage of viable cells. Production has been out of spec because that percentage has not been met at the more stringent commercial level. Barrett said that that the variability in commercial specifications isn’t unusual when you first launch into a new patient population.
“We have seen some variability in in our product specifications. We are looking to make sure we can continue to ramp up to meet demand,” Barrett told analysts.
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There have been no problems in production of Kymriah for its initial indication to treat young patients with leukemia. It also will not affect trials underway with Kymriah for other indications.
In an emailed statement, the company said, “Novartis is committed to sharing this information with treating physicians so they can make the best decision with their patients. For cases where the product does not meet commercial specifications, we have developed an Expanded Access Program path to deliver treatment, when possible.
“We are committed to resolving this as quickly as possible and to serving all patients who may be able to benefit from this transformative therapy.”
Manufacturing of the new CAR-T drugs is tricky because of the extensive process to genetically code a patient’s T cells to hunt and kill cancer cells, along with the need for speed. The process requires that blood be taken from a patient, cryopreserved, shipped to a manufacturing facility, reprogrammed and manufactured in the lab, and then shipped back for infusion into the patient, all in the shortest time possible to try to outrun aggressive cancers.
Novartis, which produces the individualize treatment at a plant in Morris Plains, New Jersey, says that in the U.S., the target turnaround time for manufacturing Kymriah is 22 days.
With its approval for DLBCL, Kymriah went into direct competition with Gilead Sciences' Yescarta. Jefferies analyst Michael J. Yee said this might provide an edge to Yescarta.