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CytomX Therapeutics Announces FDA Fast Track Designation for Varsetatug masetecan (“Varseta-M”) for Relapsed/Refractory Metastatic Colorectal Cancer (R/R mCRC)

CTMX
  • FDA granted Fast Track Designation to Varseta-M for relapsed/refractory metastatic colorectal cancer.
  • The designation follows previously reported encouraging Phase 1 data for the therapy.
  • Varseta-M is a potential first-in-class antibody drug conjugate targeting EpCAM with a topoisomerase-1 inhibitor payload.
  • CytomX Therapeutics plans to initiate a potential monotherapy registrational study in the first half of 2027.
  • Varseta-M was discovered in collaboration with ImmunoGen, now part of AbbVie.
  • The company's pipeline includes Varseta-M (CX-2051) & CX-801, developed via the PROBODY® therapeutic platform.
  • Strategic collaborations exist with Amgen, Regeneron, & Moderna.
  • Forward-looking statements regarding regulatory approvals, trial success, & development timelines are subject to significant risks.