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CAR-T in the Spotlight

By: Dr. Arie Belldegrun

Today, tisagenlecleucel, an anti-CD19 CAR-T therapy developed by Novartis, will be discussed at a U.S. Food and Drug Administration advisory committee. Novartis is seeking its approval for the treatment for pediatric or young adults with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL).

I will be Novartis’ biggest cheerleader today.

Kite and Novartis have consistently been positioned as competitors, and I am amused by the horse-race metaphors that are used to frame the various companies developing CAR-T therapies. Today is not about business or competition.  Today, we are not rivals.  Today is about advancing an exciting technology that has the potential to transform cancer treatment.

The talk of a “race” makes for great prose, but my desk isn’t covered in betting sheets. It’s covered in stacks of scientific papers that shows the promise of CAR-T technology. Stacks that are growing. With every paper I read, it becomes more and more clear that CAR-T is not a biotech race to be won, but rather a revolutionary therapy to be explored and applied to other cancers. That’s a task larger than any single company.

Today, the ideas behind CAR-T therapy will go through the most thorough public vetting they have ever received. There will be questions about how the therapy was conceived, and important and useful discussions about the manufacturing, treatment process, the risks and the benefits.

Much of what CAR-T promises will be new. Not just to patients, but to the physicians who are evaluating these new therapies for their patients. While one-shot approaches to cancer, such as stem-cell transplantation, are an established part of the armamentarium, the idea that treatment can be given only once, in a hospital setting, is a game-changing approach. I hope today’s FDA panel continues to educate on both the science and the logistical realities of this new era of medicine.

I look forward to the discussion. I expect that the committee’s vote will affirm what Novartis, Kite, and a growing crowd of other science-first companies and researchers have concluded: this is a powerful technology, and the more we can do to accelerate development, the better.

Yes, there is a race going on out there. But the real race is against time as we look to defeat cancer.