The cancer treatment industry is celebrating a massive victory on Wednesday, as Novartis (NVS - Free Report) received approval for its innovative new lymphoblastic leukemia treatment, making it the first approved CAR-T therapy in the world.
After achieving unprecedented results in patients with this deadly form of cancer, Novartis’ new therapy, which will be marketed as “Kymriah,” was officially approved by the U.S. Food and Drug Administration today.
Kymriah is an example of a CAR-T therapy. CAR-T is a newly emerging method of treating cancer that includes making genetic changes to a patient’s immune T-cells and reinjecting them into the body to attack cancer cells.
Unlike traditional medicines and treatments, each CAR-T therapy must be individually tailored to a specific patient. For this reason, patients seeking Kymriah will have to travel to one of just 32 locations around the country that can administer the therapy. From there, the harvested cells are sent to a Novartis facility in New Jersey, where they are edited and then sent back.
And the logistics aren’t the only thing that’s challenging for patients looking to receive Kymriah. Indeed, Novartis has said that just one course of treatment will cost a staggering $475,000.
Nevertheless, the prevailing reaction from the market is that this price tag is actually quite cheap, all things considered. Kymriah left about 83% of trial participants with relapsed acute lymphoblastic leukemia cancer-free after just three months.
On top of its effectiveness, Kymriah’s initial cost is also quite a bit lower than analysts were expecting. In fact, Wall Street estimates for the therapy’s opening price reached as high as $750,000 for just one dose.
For Novartis, this means that Kymriah won’t be a massive revenue generator. There are only about 3,100 new cases of acute lymphoblastic leukemia each year, and most of these can be treated with traditional drugs. Nevertheless, this is a monumental achievement for the company.
And while Novartis is the first company in the world to receive regulatory approval for a CAR-T treatment, it is hardly the only brand developing these cures. Earlier this week, we learned that biotech behemoth Gilead Sciences (GILD - Free Report) was planning to acquire CAR-T developer Kite Pharma (KITE - Free Report) for a staggering $11.9 billion (also read: Why Did Kite Pharma Stock Skyrocket Today?).
Kite’s lead CAR-T candidate, axicabtagene ciloleucel, is currently under review by the FDA. Axicabtagene ciloleucel is expected to be approved as a treatment for aggressive non-Hodgkin lymphoma, with a decision coming on or before November 29.
Elsewhere in the biotech space, companies like Juno Therapeutics (JUNO - Free Report) and Bluebird Bio (BLUE - Free Report) are working to develop CAR-T therapies. Both of these researchers watched their stock prices skyrocket in response to the Kite buyout, as investors speculated that they could also become takeover targets soon.
Kymriah’s approval marks the beginning of what could become a monumental moment for biotech investors, but more importantly, it is the first in what will hopefully be a long list of world-changing cancer treatments.
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