Knight Therapeutics Inc. announced that its Colombian affiliate, Biotoscana Farma S.A. has obtained INVIMA approval for Halaven® (eribulin) injection. 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. 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).