Radiopharmaceutical targeted toward treatment-resistant cancer put on FDA's Fast Track
An investigational radiopharmaceutical treatment has just been put on the U.S. Food and Drug Administration’s Fast Track to approval.
Atkis Oncology Inc.—a clinical-stage oncology company that specializes in developing targeted radiopharmaceuticals—announced its radioconjugate AKY-1189 had received the FDA’s Fast Track designation on Tuesday. AKY-1189, which was developed with the help of Atkis’ proprietary miniprotein radioconjugate platform, was designed to treat locally advanced or metastatic urothelial cancer that has continued to progress despite the use of systemic therapies.
The treatment targets cancers that express Nectin-4, a protein found in 80% to 90% of urothelial cancer patients. It delivers a potent alpha-emitting radioisotope, actinium-225, directly into tumors. This method effectively treats cancerous tumors while sparing the healthy tissues surrounding them.
Experts involved in its development are hopeful that the drug could help more patients with metastatic urothelial cancer beat the disease.
“The granting of Fast Track designation affords us a unique opportunity to work closely with the FDA to potentially expedite the development and review process of AKY-1189 with the goal of addressing this unmet medical need by bringing a new therapeutic option to patients with locally advanced or metastatic urothelial cancer," Akos Czibere, MD, PhD, chief medical officer of Aktis Oncology, said in an announcement.
The FDA’s Fast Track designation is reserved for drugs capable of treating serious conditions, especially those that lack effective therapeutics and are likely to progress if left untreated. It expedites the review process and streamlines communication between the FDA, developers and researchers.
The drug also is currently being tested for its treatment utility in locally advanced or metastatic urothelial cancer, breast cancer, non-small cell lung cancer, colorectal cancer, cervical cancer, and head and neck cancer in a Phase 1b clinical trial. Preliminary results from the first phase are expected to be released in the first quarter of 2027.
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In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.