The entire pharmaceutical industry with great interest watched at FDA’s Oncologic Drugs Advisory Committee meeting Wednesday, where Novartis received support for its lead CAR-T drug.
By a 10-0 vote, FDA panel experts endorsed tisagenlecleucel-T to treat patients aged 3 to 25 with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL). The FDA doesn’t have to follow its committee recommendations but typically does. The FDA’s action date for the drug is set for October.
After the vote, one of the experts said that this is one of the most exciting treatments he’s seen in his life. Another called it “major advance”, that’s “ushering in a new era of treatment.”
When CAR-T drugs do go on sale, they will be expensive. An analysis conducted by U.K. cost watchdog NICE back in March found that they could be worth up to $649,000 in childhood leukemia. Head of Novartis Research Department Vas Narasimhan told Bloomberg last month that the company considers stem cell transplantation as a potential benchmark, and weighs the prices of services to help fund the treatment.
A Novartis spokesperson previously said that it is too early for the company to comment on prices, and this should be dealt with after approval.