FDA to Expedite Review of Novel Drug to Treat Common Side Effect of Cancer


The FDA granted abelacimab a fast track designation for the treatment of thrombosis, a common and sometimes deadly type of blood clot associated with cancer.

Anthos Therapeutics announced its novel drug abelacimab was granted a fast track designation from the Food and Drug Administration (FDA) to treat thrombosis that is associated with cancer.

“Caring for cancer patients is a delicate and complex process, requiring a fine balance between the risks and benefits of their anticoagulant treatments,” Dr. Jean Marie Connors, an associate professor of hematology at Harvard Medical School in Boston, said in a 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 FXI inhibitors, such as abelacimab, may represent an important treatment advance in how we manage patients moving forward.”

Of note, a fast-track designation is granted to an investigational drug that, if approved, would address a serious unmet medical need. The designation from the FDA means that the agency will work closely with the manufacturer to facilitate the development and expedited review of the drug.

If the FDA deems that the drug meets certain criteria, the agency may decide to grant the drug a priority review or accelerated approval.

Venous thromboembolism (VTE), also known as blood clots, is the second most common cause of death in patients with cancer, according to the release. The types of VTE may range from a deep vein thrombosis (DVT) or a pulmonary embolism (PE). A DVT, according to the National Heart, Lung, and Blood Institute, occurs when a blood clot forms in a deep vein, which usually occurs in the lower half of a patient’s body. When a blood clot breaks loose and travels through the blood to the lungs, that is known as a PE.

In fact, data published in Thrombosis Research suggested that an estimated 4% to 20% of patients with cancer will develop VTE at some point during the course of their disease.

According to Memorial Sloan Kettering Cancer Center in New York City, people with cancer are at an increased risk for DVT because some genetic changes that cause cancer to develop also increase clotting. Moreover, chemotherapy used to treat cancer may also increase the risk of clotting.

“We believe that abelacimab has the potential to provide patients with cancer-associated thrombosis an enhanced safety prole and overall low risk of bleeding, without sacrificing any efficacy of currently available agents,” Dan Bloomfield, chief medical officer at Anthos Therapeutics, said in the release. “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. Fast track designation by the FDA is a significant milestone for abelacimab and Anthos Therapeutics, but more importantly represents another hopeful step forward for patients.”

There are two ongoing clinical trials assessing the safety and efficacy of abelacimab among approximately more than 2,500 patients across 220 treatment facilities in more than 20 countries, according to the release.

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