Nordic Nanovector ASA said the U.S. Food and Drug Administration granted fast-track status to its blood cancer drug Betalutin.
The designation covers the drug, also known as 177Lu-lilotomab satetraxetan, as a treatment for patients who received at least two earlier systemic therapies for a type of hard-to-treat blood cancer that had relapsed, the Oslo-based biopharmaceutical company said.
The designation is based on safety and efficacy data from an early stage trial for non-Hodgkin's lymphoma, Nordic Nanovector Chief Medical Officer Lisa Rojkjaer said in a news release.
The FDA's fast-track process is designed to facilitate development and expedite the review of drugs used to treat serious conditions and fill an unmet medical need. The status also provides eligibility for accelerated approval and priority review, given the appropriate criteria are met.
