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Landmark Israeli Cancer  Treatment Approved by FDA



Less than two months after being acquired by Pharmaceutical giant Gilead for $12B, Israel-based biotech company Kite Pharma obtained US Food and Drug Administration (FDA) approval for a cancer treatment drug they have been developing last Wednesday.

The drug, called YESCARTA, is aimed at treatment of certain types of blood cancer called non-Hodgkin lymphoma.

What Yescarta does is utilize white blood T-cells and ‘reprograms’ them to fight cancer cells. A single treatment with this drug will cost $373,000 in the US currency and speculation abounds that it could generate hundreds of millions in sales.

According to Reuters, and was reported by the JPost, the price of Yescarta is set below that of comparable treatments, as Novartis AG’s gene therapy costs $475,000. The Novartis gene therapy, given the regulatory nod in August, is administered to attack child leukemia. The high price of the drugs, called CAR-Ts, may set off a debate about the bioethical implications of making life-saving pharmaceuticals unaffordable.

The JPost report also indicated that “what distinguishes the Israeli-owned drug from other pharmaceuticals is that each dose offers a personalized treatment, made directly from the patient’s own immune system to fight the lymphoma. Called immunotherapy, the patient’s infection-fighting T-cells are extracted and genetically engineered with a new gene to pinpoint and kill the lymphoma cells. After the cells are modified, they are infused back into the patient, where they patrol for years.”

“The FDA approval of Yescarta is a landmark for patients with relapsed or refractory large B-cell lymphoma. This approval would not have been possible without the courageous commitment of patients and clinicians, as well as the ongoing dedication of Kite’s employees,” said Dr. Arie Belldegrun, founder of Kite.

“Today is an important day for patients with relapsed or refractory large B-cell lymphoma who have run out of options and have been waiting for new treatments that may help them in their fight against cancer,” said John Milligan, President and Chief Executive Officer of Gilead Sciences. “With the combined innovation, talent and drive of the Kite and Gilead teams, we will rapidly advance cell therapy research and aim to bring new options to patients with many other types of cancer.”

“Today marks another milestone in the development of a whole new scientific paradigm for the treatment of serious diseases. In just several decades, gene therapy has gone from being a promising concept to a practical solution to deadly and largely untreatable forms of cancer,” said Food and Drug Administration Commissioner Scott Gottlieb in a statement.

The treatment was first developed at the National Cancer Institute, led by Dr. Steven Rosenberg, who signed an agreement with Kite Pharma in 2012. Kite helped fund the research process, in return for receiving patent royalties.

Approval of the treatment has led to a four percent spike in Gilead stock.

By: Yona Schnitzer

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