Knight Therapeutics obtains Halaven® approval in Colombia

Knight Therapeutics Inc. announced on January 6, 2022, that its Colombian affiliate, Biotoscana Farma S.A., has obtained regulatory approval from INVIMA for Halaven® (eribulin) injection. The approval allows for the treatment of adult patients with locally advanced or metastatic breast cancer that has progressed after at least two prior chemotherapy regimens. Halaven® is also indicated for patients with advanced or metastatic liposarcoma who are unsuitable for surgical resection.

Breast cancer is the most frequently diagnosed cancer among women in Colombia, with an estimated 15,509 new cases in 2020. Additionally, approximately 1,500 patients are diagnosed with soft tissue sarcoma annually in Colombia, with liposarcoma being the most common subtype. Clinical studies have shown that Halaven® (eribulin) significantly improves overall survival in patients with advanced breast cancer, extending it by an average of 2.5 months compared to existing therapies.

"We are pleased to announce the approval of Halaven® (eribulin) injection in Colombia as it provides a new treatment option for metastatic breast cancer and liposarcoma," said Samira Sakhia, President and CEO of Knight Therapeutics. "Our Colombian team is focused on our oncology launches with the approval of Halaven® (eribulin) injection and Lenvima® (lenvatinib), and will coordinate launch efforts with our teams throughout the region."

Knight holds an exclusive license from Eisai to commercialize certain drugs, including Lenvima® (lenvatinib), Halaven® (eribulin), Fycompa® (perampanel), and Inovelon® (rufinamid), across Latin America, with the exception of Mexico, where Eisai retains commercialization rights for Lenvima® and Halaven®.