FDA approves Orca Bio's Tregzi T-cell therapy reducing transplant complications in blood cancer

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The Food and Drug Administration on Tuesday approved a personalized T-cell therapy from Orca Bio, a private biotech company, that reduces the risk of a debilitating immune reaction in patients with blood cancers undergoing stem cell transplants.

The Orca therapy, called Tregzi, represents an alternative approach to traditional matched-donor stem cell transplantation that can be curative for certain patients with blood cancers, but also carries a high risk of chronic graft-versus-host disease and other long-term complications.

“This is going to be a really important option for leukemia patients,” said Nate Fernhoff, Orca’s CEO, in an interview with STAT. “Historically, the choice for a stem cell transplant carried a trade off — risks and complications that patients had to accept as part of treatment in search of a cure. With Tregzi’s approval, we hope to show that we can break that trade off, and that we can improve survival free from graft-versus-host disease.”

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