The Food and Drug Administration (FDA) has granted Fast Track designation to abelacimab for the treatment of thrombosis associated with cancer.

Abelacimab is a highly selective, fully human monoclonal antibody designed to induce hemostasis-sparing anticoagulation by inhibiting both factor XI and its activated form, factor XIa. The abelacimab phase 3 program in cancer associated thrombosis consists of 2 open-label, blinded endpoint evaluation clinical trials: ASTER (ClinicalTrials.gov Identifier: NCT05171049) and MAGNOLIA (ClinicalTrials.gov Identifier: NCT05171075).

In the ASTER study, the effect of abelacimab on venous thromboembolism (VTE) recurrence and bleeding will be compared with apixaban in patients with cancer associated VTE in whom direct oral anticoagulant (DOAC) treatment is recommended. The MAGNOLIA trial will compare the effect of abelacimab to dalteparin on VTE recurrence and bleeding in patients with gastrointestinal/genitourinary cancer associated VTE in whom DOAC treatment is not recommended. In both trials, abelacimab will be administered intravenously on day 1 and subcutaneously monthly thereafter for up to 6 months.

“We believe that abelacimab has the potential to provide patients with cancer associated thrombosis an enhanced safety profile and overall low risk of bleeding, without sacrificing any efficacy of currently available agents,” said Dan Bloomfield, Chief Medical Officer at Anthos Therapeutics. “This unmet need is particularly true in patients with gastrointestinal/ genitourinary cancers who are at an even higher risk of bleeding and can be further burdened by the inconvenience of daily injections.”

Reference

Novel Factor XI Inhibitor Fast Tracked for Thrombosis Associated With Cancer

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