FDA grants fast-track designation to second CAR T-cell therapy for lupus nephritis
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Key takeaways:
- The FDA has issued its second fast-track designation in a month for a CAR T-cell therapy indicated for lupus nephritis.
- The manufacturer is recruiting patients with lupus nephritis for a phase 1 trial. Kyverna has filed for a similar trial in the European Union.
The FDA has granted fast-track designation to Kyverna’s KYV-101, a novel anti-CD19 chimeric antigen receptor T-cell therapy for patients with refractory lupus nephritis, according to a company press release.
“The FDA granting us fast-track designation for KYV-101 means we can move more quickly toward bringing this potentially transformative and life-saving medicine to patients with lupus,” Kyverna CEO Peter Maag, PhD, said in the release. “We believe KYV-101 has the potential to drive greater and more rapid reduction of disease activity in patients with [lupus nephritis], and we look forward to sharing clinical data on patients in the second half of 2023.”
KYV-101 will be investigated in a phase 1, open-label, multicenter trial in the United States, according to the company. Kyverna is now “actively recruiting” patients for the phase 1 trial, the release said.
Additionally, Kyverna has filed for approval of a parallel phase 1/2 trial of KYV-101 in Germany among patients with lupus nephritis.
The announcement comes almost exactly 1 month after the FDA issued another fast-track designation to Cabaletta Bio’s CABA-201, another CD19-CAR T-cell investigational therapy, for the treatment of systemic lupus erythematous and lupus nephritis.
Both therapies are designed to deplete B cells in an effort to reduce the burden of disease activity in patients.
FDA fast track designation is intended to expedite the development and review of drugs that fulfill an unmet need in serious diseases. Benefits of the designation include the potential for more frequent meetings with the FDA during clinical development, eligibility for accelerated approval or priority review, and the ability to submit sections of a biologics license application on a rolling basis.
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