On January 6, 2022 Knight Therapeutics Inc. (TSX:GUD) ("Knight" or "the Company") reported that its Colombian affiliate, Biotoscana Farma S.A. has obtained INVIMA approval for Halaven (eribulin) injection (Press release, Knight Therapeutics, JAN 6, 2022, View Source;Announces-Approval-of-Halaven174–in-Colombia-1-6-2022 [SID1234598361]).
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Halaven (eribulin) injection is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer which has continued to spread after at least two previous treatment for advanced cancer. Previous treatment should have included anthracyclines and a taxane in either the adjuvant or metastatic setting, unless these treatments were not suitable. Halaven(eribulin) injection is also used to treat patients with advanced or metastatic liposarcoma that cannot be surgically removed. It is used in patients who have already been treated with an anthracycline, unless deemed unsuitable.
Halaven (eribulin) injection has shown to significantly improve overall survival in patients with advanced or metastatic breast cancer after anthracycline and taxane treatment. Halaven (eribulin) injection indicated extended overall survival (OS) of 2.5 months (OS of 13.1 months versus 10.6 months, respectively; Hazard Ratio (HR) 0.81; p=0.041) when compared to selected, major existing therapies1. Also, Halaven (eribulin) injection demonstrated a statistically significant extension in overall survival over the comparator treatment dacarbazine in patients with locally advanced/recurrent or metastatic soft tissue sarcoma (liposarcoma or leiomyosarcoma) who had disease progression following standard therapies 2.
Breast cancer is now the most frequently diagnosed cancer in Colombian women. In 2020, an estimated 15,509 patients were diagnosed with breast cancer3. Further, approximately 1,500 patients in Colombia are diagnosed with soft tissue sarcoma each year, and liposarcoma, an area with high unmet medical need, represents the most common form of soft tissue sarcoma4.
"We’re 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 & Chief Executive Officer. "Our Colombian team is focused on our oncology launches with the approval of Halaven (eribulin) injection and Lenvima (lenvatinib) and will be coordinating launch efforts with our teams throughout the region."
Knight has an exclusive license from Eisai to commercialize Lenvima (lenvatinib), Halaven (eribulin) injection, Fycompa (perampanel), and Inovelon (rufinamide) throughout Latin America, with the exception of Mexico where Eisai retains the rights to Halaven (eribulin) injection and Lenvima (lenvatinib).
About Halaven (eribulin) injection
Discovered and developed by Eisai, eribulin is a synthetic analog of halichondrin B, a natural product that was isolated from the marine sponge Halichondria okadai. First in the halichondrin class, eribulin is a microtubule dynamics inhibitor. Eribulin is believed to work primarily via a tubulin-based mechanism that causes prolonged and irreversible mitotic blockage, ultimately leading to apoptotic cell death. Additionally, in preclinical studies of human breast cancer, eribulin demonstrated complex effects on the tumor biology of surviving cancer cells, including increases in vascular perfusion resulting in reduced tumor hypoxia, and changes in the expression of genes in tumor specimens associated with a change in phenotype, promoting the epithelial phenotype, opposing the mesenchymal phenotype5-6. Eribulin has also been shown to decrease the migration and invasiveness of human breast cancer cells5-6.