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Novartis gets green light for gene therapy

The U.S. Food and Drug Administration FDA has approved Kymriah, a therapy developed by the Basel-based pharmaceutical giant Novartis to treat a type of leukemia. It is the first gene therapy to be approved in the USA.

Novartis HQ
Image Credit: Novartis

Kymriah has been approved for the treatment of B-cell precursor acute lymphoblastic leukemia (ALL) in children and young adults aged up to 25, announced Novartis in a statement.

The therapy reprograms cells from within a patient’s body before injecting them back into the blood, where they bind to and destroy cancer cells.

The pharma giant described the approval as a breakthrough in cancer therapy. According to CEO Joseph Jimenez, the company has once again delivered on its commitment to change the course of cancer care.

The FDA calls its approval "a historic action“. "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 according to a press release.

Novartis now plans to make the therapy available to affected patients with different health insurances as quickly as possible.

Working with the Center for Medicare & Medicaid Services (CMS), it plans to allow payment only when a patient responds to the treatment within a month.

The cell therapy developed by Novartis was granted Breakthrough Therapy designation in 2014 and was recommended for approval by the FDA’s advisory committee in July.  

Novartis is planning additional filings for Kymriah in the USA and Europe, including applications for the treatment of r/r diffuse large B-cell lymphoma (DLBCL).

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