FDA approves Genentech Tecentriq as adjuvant ctDNA-guided therapy for muscle-invasive bladder cancer

Natera, Inc.

Natera, Inc.

NTRA

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  • FDA cleared Genentech Tecentriq, including Tecentriq Hybreza, as adjuvant therapy for adults with muscle-invasive bladder cancer who test ctDNA MRD-positive after cystectomy using Natera Signatera CDx.
  • Approval was backed by Phase III IMvigor011, showing 36% lower risk of disease recurrence or death, 41% lower risk of death in ctDNA-positive patients treated within 1 year of surgery.
  • Decision marks Tecentriq eleventh US indication, creating first FDA-approved ctDNA-guided MRD treatment approach in this setting.


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