Key takeaways:

  • Avenzo Therapeutics' AVZO-103 got FDA Fast Track for urothelial cancer.
  • AVZO-103 targets Nectin4 and TROP2, found on many solid tumours.
  • Fast Track is for patients who already had enfortumab vedotin.
  • If approved, it’s the first of its kind for this group.
  • FDA Fast Track speeds up drug review for serious unmet needs.

Avenzo therapeutics have announced that their bispecific ADC candidate, AVZO-103, has been granted Fast Track designation by the US FDA for the treatment of urothelial cancer. The designation grants Avenzo’s candidate an expedited approval process.

AVZO-103

AVZO-103 targets Nectin4 and TROP2 and carries a cytotoxic payload. Its dual targets help enhance binding and internalisation of the drug. Nectin4 and TROP2 are expressed on many solid tumour indications including urothelial and breast cancers. Avenzo is currently conducting a Phase 1/2 study of the drug for the treatment advanced solid tumour.

Avenzo were offered Fast Track designation for use in patients with locally advanced or metastatic urothelial cancer as a line of care after they have already been treated with enfortumab vedotin. If approved, it would be the first drug of its kind for patients previously treated with enfortumab vedotin.

‘Highlights the significant need for treatment options’

“Receiving Fast Track designation for AVZO-103 highlights the significant need for treatment options for patients with urothelial cancer who have progressed on enfortumab vedotin,” said Mohammad Hirmand, Co-founder and Chief Medical Officer at Avenzo Therapeutics.

He continued: “We believe AVZO-103 has the potential to become a promising treatment option for patients and we are committed to rapidly advancing its clinical development.”

Fast Track Designation

Fast Track is an FDA program that speeds up drug development and review for serious conditions with unmet needs. Fast Track drugs can benefit from more frequent FDA meetings and communications about development plans and trial design; Eligibility for Accelerated Approval and Priority Review if criteria are met; and Rolling Review of its Biologic License Application or New Drug Application.