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News Worms


Novartis' CAR-T Drug Win Helps Gilead To Spike Post Kite Deal

Novartis' CAR-T Drug Win Helps Gilead To Spike Post Kite Deal

Novartis AG on Wednesday won highly anticipated USA approval for the first of a new type of potent gene-modifying immunotherapy for leukemia, a $475,000 treatment that marks the start of a potential new treatment paradigm for some cancers.

The Food and Drug Administration called the approval historic, the first gene therapy to hit the USA market. It is made from scratch for every patient. It is the first gene therapy to be allowed in the United States - a "historic" approval, the agency said. Those T cells then are infused back into the patient. It transforms a patient's immune system cells to fight a form of leukemia. With CAR-T, some T-cells are removed from a patient's blood.

Juno Therapeutics Inc previous year reported a handful of patient deaths during trials of its CAR-T therapy for leukemia.

"We're entering a new frontier in medical innovation with the ability to reprogram a patient's own cells to attack a deadly cancer", said FDA Commissioner Scott Gottlieb, MD.

In a pivotal study of five dozen patients, the drug induced remission in more than 80 percent.

"The theory is they should attack the tumor and continue to grow to become a long-term monitoring and treatment system", Lichtenfeld said. "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". "I wouldn't say we know for sure how many will be cured yet by this therapy".

The treatment, which is expected to be costly, can cause serious side effects including high fevers and neurological problems. The FDA designated a treatment for those side effects Wednesday.

Dr. Kenneth Anderson is president of the American Society of Hematology, which focuses on blood cancers.

Kite's action date at the agency with its lead CAR-T medication, Axi-Cel, is in November.

"Unfortunately leukemia grows so rapidly that it can evade even the smartest of our technologies", he added. Novartis said it hopes to have an initial network of 20 treatment centers within a month with plans to expand that to 32 by the end of the year. Most of these symptoms should appear within three weeks of infusion with Kymriah, the FDA said. The $475,000 price tag doesn't include the cost of needed hospitalizations, travel to a certified hospital and other expenses.

Unlike traditional gene therapy, the new treatment doesn't replace disease-causing genes with healthy ones. Kymriah's maker, Novartis, hasn't provided a price for the drug. But if it's the last treatment they need, "that's a really significant one-time investment in their wellness, especially in kids who have a whole lifetime ahead of them". "This is a potentially curative therapy in patients whose leukemia is unresponsive to other treatments". "With the approval of Kymriah, we are once again delivering on our commitment to change the course of cancer care".

Manufacturing and delivery are more complex in CAR-T therapies than for a typical drug. Research is therefore focusing for now on refining the therapy for patients of this disease. "Approvals are an important step, but they're just the beginning".

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