News|Articles|February 24, 2026

FDA OKs Fast Track to AKY-1189 in Metastatic Urothelial Cancer

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Key Takeaways

FDA fast track enables increased FDA-company interactions and potential rolling BLA submission to accelerate development for serious diseases with unmet need.
AKY-1189 uses a miniprotein radioconjugate to target Nectin-4 and deliver actinium-225 alpha-emitting cytotoxicity to tumor cells.
High Nectin-4 prevalence in urothelial carcinoma (≈80%–90%) supports target selection, particularly in post–systemic therapy and post–enfortumab vedotin populations.
A multi-tumor U.S. phase 1b trial includes urothelial, breast, NSCLC, colorectal, cervical, and head and neck cancers, with preliminary Part 1 readout planned Q1 2027.
Aktis’ isotope-agnostic platform emphasizes tumor penetration/internalization with rapid normal-tissue clearance and allows pre-therapy target engagement assessment using imaging isotopes.

FDA granted fast track designation to AKY-1189 for adults with metastatic urothelial cancer after systemic therapy, aiming to speed development of the investigational drug.

The U.S. Food and Drug Administration (FDA) has granted fast track designation to AKY-1189 for adults in the United States with locally advanced or metastatic urothelial cancer who have progressed on or after prior systemic therapies, a step intended to help speed development of a potential new treatment option for patients with cancer who currently have limited choices.

The designation was announced Feb. 24, 2026, by Aktis Oncology, Inc., a clinical-stage oncology company based in Boston. AKY-1189 is designed for patients with locally advanced or metastatic urothelial cancer whose disease has worsened after systemic treatment. According to the company, this group of patients has limited treatment options, including those whose cancer has progressed after Padcev (enfortumab vedotin-ejfv).

What fast track designation means for patients with metastatic urothelial cancer

Fast track designation is an FDA process intended to facilitate development and expedite review of drugs that treat serious conditions and address an unmet medical need. The goal is to help bring important new drugs to patients earlier.

A drug that receives fast track designation may qualify for more frequent interactions and communications with the FDA. It may also be eligible for a rolling submission of a Biologics License Application, which allows the company to submit completed sections of its application for review rather than waiting until every section is finished.

In granting this designation to AKY-1189, the FDA recognized the ongoing need for additional treatment options for patients with locally advanced or metastatic urothelial cancer whose disease has progressed after systemic therapies.

AKY-1189 was generated using Aktis’ miniprotein radioconjugate platform. The treatment is designed to deliver actinium-225 (225Ac), described as a highly potent alpha-emitting radioisotope, directly to tumors that express Nectin-4. Approximately 80% to 90% of patients with urothelial cancer show positive expression of Nectin-4, making it a relevant target in this disease.

By directing the radioisotope to Nectin-4 expressing tumors, AKY-1189 aims to selectively deliver tumor-killing radiation to cancer cells.

Ongoing phase 1b trial of AKY-1189 in multiple nectin-4 expressing tumors

Aktis is currently conducting a multi-site phase 1b clinical trial in the United States to evaluate AKY-1189. The study is enrolling patients with locally advanced or metastatic urothelial cancer as well as several other tumor types that express Nectin-4.

In addition to urothelial cancer, the trial includes patients with breast cancer, non-small cell lung cancer, colorectal cancer, cervical cancer and head and neck cancer.

The company expects to present preliminary results from Part 1 of the trial in the first quarter of 2027.

AKY-1189 is the most advanced program in Aktis’ pipeline. The company also has a second miniprotein radioconjugate program, AKY-2519, which targets B7-H3 expressing tumors, including prostate, lung and other solid tumors. In addition, Aktis has a strategic collaboration with Eli Lilly and Company to develop novel radioconjugates outside of its proprietary pipeline using its miniprotein platform.

According to Aktis, its proprietary platform is isotope-agnostic and is designed to selectively deliver the tumor-killing properties of radioisotopes to targeted tumors. The company states that its therapeutic miniprotein radioconjugates are intended to maximize anti-cancer activity through high penetration, internalization and retention in cancer cells, while quickly clearing from normal organs and tissues.

The platform also enables clinicians to visualize and verify target engagement with imaging isotopes before exposure to therapeutic radioisotopes.

Safety information for AKY-1189

The press release did not report specific safety or side effect data for AKY-1189. As an investigational therapy, AKY-1189 continues to be studied in the ongoing phase 1b clinical trial.

Fast track designation does not mean that a drug is approved. Instead, it reflects the FDA’s recognition that the treatment may address a serious condition and an unmet medical need and allows for closer interaction during development.

Reference

“Designation for AKY-1189, a Nectin-4 Miniprotein Radioconjugate,” news release, Aktis Oncology Inc.

Editor's note: This article is for informational purposes only and is not a substitute for professional medical advice, as your own experience will be unique. Use this article to guide discussions with your oncologist. Content was generated with AI, reviewed by a human editor, but not independently verified by a medical professional.

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