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undergroundnewsroom.com October 23, 2017


FDA OKs 1st Gene Therapy for Use in US

31 August 2017, 01:45 | Rodolfo Quinn

First gene therapy coming to US after FDA approval

Novartis' CAR-T gene therapy, the first approved by FDA, to be priced based on cancer patients' outcomes

Researchers filter the cells from a patient's blood, reprogramme them with a "chimeric antigen receptor" that targets cancer, and grow hundreds of millions of copies. Although the treatment sometimes causes severe side effects, in a Novartis clinical trial the drug caused remission in 83% of 63 young patients with a certain type of leukemia, B cell acute lymphoblastic leukemia (ALL).

Novartis' CAR-T, which will be marketed as Kymriah, leads an emerging field of cell therapies created to engineer the body's immune cells to seek out and destroy cancers.

The FDA-approved drug Kymriah has been called a "living drug" because involves using genetically modified immune cells from patients to attack their cancer, according to NPR.

With the treatments available now, fewer than 10 percent of patients with the relapsed, hard-to-treat leukemia are alive five years after diagnosis.

ALL is an aggressive cancer that affects some 3,100 people aged 20 and younger each year in the United States, making it the nation's most common childhood cancer.

"We're entering a new frontier in medical innovation with the ability to reprogram a patient's own cells to attack a deadly cancer", FDA Commissioner Scott Gottlieb said in a statement. Kymriah handles this turbocharging within the patients body.

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Kymriah is a genetically-modified autologous T-cell immunotherapy.

Kymriah has a $475,000 price tag; however, patients who do not respond within a month of treatment will not be charged, according to Novartis.

While promising, CAR-T treatments won't be like other drugs that win FDA approval, which can quickly wind up on pharmacy shelves and hospitals.

However, this type of therapy is not without risk of severe side effects as the immune system goes into high gear. According to the release, other adverse events include serious infections, hypotension, acute kidney injury, fever, and hypoxia, with most symptoms appearing within 22 days after tisagenlecleucel.

The drug Kymriah was developed by Novartis Pharmaceuticals and the University of Pennsylvania.

Novartis plans additional filings for Kymriah in the USA and EU later this year, including applications with the FDA and European Medicines Agency, for the treatment of adult patients with r/r diffuse large B-cell lymphoma (DLBCL). But speaking earlier this year to The New York Times, drug industry analysts estimated that individualized therapies could cost more than $300,000. "It's not a one-shot deal".



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