FDA grants fast track designation to abelacimab for cancer-associated thrombosis
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The FDA granted fast track designation to abelacimab for treatment of cancer-associated thrombosis, according to a press release from the agent’s manufacturer.
Abelacimab (Anthos Therapeutics) is a fully human monoclonal antibody that has demonstrated dual inhibitory activity against factor XI and its activated form, factor XIa.
As Healio previously reported, results of a phase 2 study showed a single IV dose of the agent reduced blood clot risk by about 80% compared with daily enoxaparin without increasing bleeding risk after total knee arthroplasty.
“We believe that abelacimab has the potential to provide patients with cancer-associated thrombosis an enhanced safety profile and overall low risk [for] bleeding, without sacrificing any efficacy of currently available agents,” Dan Bloomfield, chief medical officer of Anthos Therapeutics, said in the press release. “This unmet need is particularly true in patients with gastrointestinal/genitourinary cancers who are at an even higher risk [for] bleeding and can be further burdened by the inconvenience of daily injections.”
Two randomized phase 3 trials will assess abelacimab for patients with cancer-associated thrombosis.
The ASTER trial, which enrolled its first patient in May, will evaluate the impact of abelacimab vs. the factor Xa inhibitor apixaban (Eliquis, Bristol Myers Squibb/Pfizer) on venous thromboembolism recurrence and bleeding among patients for whom direct oral anticoagulants are recommended.
The MAGNOLIA trial will compare abelacimab with dalteparin (Fragmin, Pfizer) among patients with gastrointestinal or genitourinary cancer for whom direct oral anticoagulants are not recommended.
The trials will enroll about 2,700 patients across 220 sites globally, according to the press release.
“Caring for [patients with cancer] is a delicate and complex process, requiring a fine balance between the risks and benefits of their anticoagulant treatments,” Jean Marie Connors, MD, associate professor of hematology at Harvard Medical School, said in the press release. “Managing thrombosis episodes is of the utmost importance for physicians, patients and their caregivers, as untreated blood clots or bleeding episodes associated with currently available anticoagulants can have dire consequences. The hemostasis-sparing potential of [factor XI] inhibitors, such as abelacimab, may represent an important treatment advance in how we manage patients moving forward.”
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