Eliquis (ingredient: apixaban), sold by BMS and Pfizer, recently added cancer-associated venous thromboembolism (VTE) treatment in approval conditions, the government said.

The Ministry of Food and Drug Safety changed the clause of the “precautions for use” in approval conditions for Eliquis late last year.

Eliquis, sold by BMS and Pfizer, recently added cancer-associated venous thromboembolism (VTE) treatment in approval conditions.
Eliquis, sold by BMS and Pfizer, recently added cancer-associated venous thromboembolism (VTE) treatment in approval conditions.

With the latest change, Eliquis became a treatment option for cancer patients who have a high risk of VTE, including deep vein thrombosis (DVT) and pulmonary embolus (PE), and bleeding.

In Korea, the only non-vitamin K antagonist oral anticoagulants (NOAC) that can treat cancer-associated VTE are Eliquis and Xarelto (rivaroxaban).

The incidence of VTE, the third major cause of cardiovascular death, almost doubled from 23.9 per 100,000-population in 2009 to 42.2 per 100,000 in 2016.

The annual incidence rate of VTE among people aged 60 and older is 13-14 times higher than that among people aged 20-39 and five times higher than those aged 20-59. Thus, VTE became a public health issue caused by population aging.

The addition of the precautions for use was based on the phase 3 CARAVAGGIO study of Eliquis.

CARAVAGGIO evaluated Eliquis’ VTE recurrence prevention effect and safety from bleeding in 1,155 DVT or PE patients with cancer, compared to dalteparin, for six months.

The results were released at the annual meeting of the American College of Cardiology in 2020 and published in the New England Journal of Medicine.

Eliquis proved the effect to prevent VTE and was non-inferior to dalteparin without an increased risk of bleeding in DVT or PE patients with cancer.

Kang Seong-sik, Pfizer Korea’s Country Medical Director, said VTE patients with cancer have a higher incidence of bleeding complications and recurrent VTE during anticoagulation therapy compared to VTE patients without cancer.

That is why anticoagulants had limitations in safety against bleeding, he said.

It is very encouraging that Eliquis’ effect of preventing VTE and was non-inferior to dalteparin without an increased risk of bleeding in DVT or PE patients with cancer in the CARAVAGGIO study led to changes in approval conditions, he added.

Lee Hyeong-bok, Business Unit Lead at BMS Korea, said the U.S. National Comprehensive Cancer Network recommends apixaban as Category 1 drug to treat cancer-associated VTE, based on the outcome of the CARAVAGGIO study.

“In Korea, Eliquis is the only NOAC that can be used for those patients and recommended as Category 1,” he emphasized.

BMS and Pfizer will continue to support research that has the potential to improve understanding of scientific knowledge and provides better treatment to patients, Lee said.

He added that the two would also make efforts to create a better treatment environment for VTE patients in Korea.

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