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Novartis Goes First

Novartis' CAR-T cell therapy is now the first of its kind to be approved by the FDA, reports Marketwatch. The pharmaceutical company's Kymriah, the first gene therapy available in the US, will be accessible to young people up to age 25 with a form of acute lymphoblastic leukemia.

There had already been massive speculation about CAR-T cell therapy, with investors betting on which company was going to be the first to see its treatment approved. Gilead Sciences just paid $11.9 billion to acquire Kite Pharmaone of the leading players in the CAR-T therapy field. For MIT's Technology Review, the huge price tag attached to the acquisition is a "clear sign" that the genetic engineering approach to developing cancer therapeutics from Kite, Novartis, and their competitors is the wave of the future.

Now that the first drug in this field has been approved, the speculation has shifted to pricing, Marketwatch says. Novartis hasn't yet said how it plans to price Kymriah.

On Wednesday, the FDA also expanded approval of Genentech's rheumatoid arthritis drug Actemra to treat CAR-T cell-induced cytokine release syndrome, which consists of high fever and flu-like symptoms and can be life-threatening, Marketwatch added.

In a statement, the Fred Hutchinson Cancer Research Center lauded the FDA's decision. David Maloney, medical director of cellular immunotherapy at Fred Hutch and medical director of the Bezos Family Immunotherapy Clinic at Seattle Cancer Care Alliance, called the ruling a milestone, and "an important validation of technical advances under way in the field of cellular immunotherapy where we are modifying cells from a patient's own immune systems to seek out and eliminate cancer cells."

Fred Hutch says it is currently testing new experimental T-cell therapies for breast cancer, leukemia, lymphoma, lung cancer, Merkel cell carcinoma, and mesothelioma.