"Not only does Kymriah provide these patients with a new treatment option where very limited options existed, but a treatment option that has shown promising remission and survival rates in clinical trials", said Peter Marks, MD, PhD, director of the FDA.
Its approval is likely to set the stage for the FDA to approve a slew of CAR-T drugs over the next several years.
This article will be updated.
At the time, American Cancer Society Deputy Chief Medical Officer Dr. Len Lichtenfeld said the real promise of these gene therapies is the potential to completely eradicate specific cancers both for the single patient as well as all their descendants. "New technologies such as gene and cell therapies hold out the potential to transform medicine and create an inflection point in our ability to treat and even cure many intractable illnesses".
Each dose of Kymriah contains a patient's own immune cells, which are sent to a lab to be genetically modified using a virus.
But he and other researchers say thousands more patients eventually may benefit.
Returned to the patient, the cells can continue multiplying to fight disease for months or years.
"There has been an urgent need for novel treatment options that improve outcomes for patients with relapsed or refractory B-cell precursor ALL", Novartis, the drug company that makes Kymriah, said in a statement. This therapy - known as chimeric antigen receptor T-cell therapy, or CAR-T - gives the cells the ability to recognize and kill the source of the cancer.
Because patients can develop life-threatening side effects weeks after the procedure, doctors will ask patients to stay within two hours of the hospital for up to a month. Kymriah will carry a boxed warning for cytokine release syndrome, a potentially lethal systemic response to the activation and proliferation of CAR-T cells, causing high fever and potential for neurological problems.
Because of these safety concerns, the FDA will require that hospitals receive special certification to use Kymriah, the agency said.
On Wednesday, the FDA also expanded approval for another drug, tocilizumab, to treat CRS in patients 2 and older.
For some patients, the new CAR-T therapy might replace bone marrow transplants that cost more than half a million dollars, noted Grupp, who led the Novartis study. Novartis said it expects between 30 and 35 centers to be certified to offer the treatment by the end of the year.
The FDA also is considering a auto T-cell therapy from California-based Kite Pharma.
August 27, 2017: Susan Bro and the Miller Law Group today announced the launch of the Heather Heyer Foundation . Alessia Cara spoke out about body-shaming. "Please visit our website to help me make Heather's death count".
The incident in question involved some of the players using funds issued by the school for a specific goal to buy electronics. No. 17 Florida's task in its high-profile season-opener against No. 11 MI just got even more hard .
In fact, she issued an apology to him, saying she never once said anything negative about him since news of the sex scandal broke. Many of his pals defended Jackson against her accusation, including his ex-girlfriend, Lexi Thexton .
At the time, his removal from the visit raised fresh questions about Spicer's standing as the chief White House spokesman. Spicer announced he was resigning as Press Secretary last month, and was replaced by Sarah Huckabee Sanders.
This is on top of what CeX stresses was always a robust security system, which it says was continually updated. As well as its hundreds of stores, the company also operates the webuy.com online marketplace.
A new series of shorts plans to explain some of the important shifts in the mythology of replicants and replicant hunters. The Blade Runner sequel will pick up a few years after the events of this short film in the titular year of 2049.
Pets Alive worked in conjunction with several area rescue groups in Orange County, and was the staging area for the incoming dogs. The Humane Society expects thousands of animals to be impacted by the storm, spokesperson Samantha Miller told CBS News.
Former FBI Director Robert Mueller has reportedly issued subpoenas to Paul Manafort's former lawyer and his current spokesman. Spokesmen and spokeswomen for the committee's leaders did not immediately respond to requests for comment on the report.
We hope the statue will help all those who visit Kensington Palace to reflect on her life and her legacy'. We hate the thought that Princess Diana was that miserable in her marriage when it had only started.
At least nine people are reported to have died as a result of Hurricane Harvey , the worst storm to strike the U.S. in 12 years. The church is set to be used as a donation center and was scheduled to open at noon on Tuesday.
Apple Secret Revealed with the New iPhone 8 Leak
The display promises to stretch from edge to edge with only a notch in the top for the earpiece and front-facing sensors. Next year, though, Apple is reportedly planning to launch three iPhone models in the coming iPhone cycle .
Google augments Android with ARCore
Essentially Google's answer to Apple's ARKit , and definitely a rebranding (at least partially) of Project Tango . Need some ideas? Check out Google's new AR Experiments showcase to jolt your imagination.