Samjin Pharmaceutical said on the 6th that it launched Fulveserd injection (ingredient name fulvestrant), a treatment for advanced and metastatic breast cancer.
Fulveserd injection is a selective estrogen receptor degrader (SERD). It works by degrading and removing estrogen receptors involved in cancer cell growth, and it can be effective even in patients who have developed resistance to existing hormone therapy.
The treatment is used for patients who are hormone receptor (HR)-positive and HER2-negative, who account for about 70% of breast cancer patients in Korea.
It can be used alone in patients with advanced or metastatic breast cancer before or after menopause, and when the disease has progressed after endocrine therapy, it can be used with the CDK4/6 inhibitors palbociclib, abemaciclib and ribociclib.
Accordingly, the company expected that various treatment strategies could be selected to suit the patient's treatment stage and condition.
The main ingredient, fulvestrant, demonstrated treatment efficacy in global clinical trials. In a phase 3 trial in patients with postmenopausal advanced breast cancer, it significantly extended progression-free survival (PFS), the period during which the disease did not worsen, compared with the control anastrozole. In another trial in patients whose disease progressed after first-line endocrine therapy, it reduced the risk of disease progression and increased overall survival.
Kim Sang-jin, president of Samjin Pharmaceutical, said, "Fulveserd injection, based on an ingredient with efficacy verified in global trials, will be able to offer a range of treatment options from monotherapy to combination therapy with major CDK4/6 inhibitors," adding, "We will continue to supply high-quality medicines to help improve patients' quality of life."