RMAT designation for Yescarta in first-line high-risk LBCL
The US Food and Drug Administration (FDA) has granted the Gilead Sciences (Nasdaq: GILD) subsidiary Kite a Regenerative Medicine Advanced Therapy Designation (RMAT) for Yescarta (axicabtagene ciloleucel) for adults with newly-diagnosed, high-risk large B-cell lymphoma (LBCL).
Suitable patients are identified through a positive positron emission tomography (PET) scan after two cycles of first-line chemoimmunotherapy. High-risk LBCL is a disease characterized by an aggressive course, early and frequent relapses, and low long-term survival rates.
Since Yescarta was first approved as third-line plus treatment for adult patients with LBCL in 2017, followed by approval as second-line treatment in 2022, Kite has been focused on bringing the curative potential of CAR T-cell therapy as early in patients’ treatment course as possible.
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