Farletuzumab is an investigational humanized IgG₁ antibody targeting folate receptor alpha which is over-expressed on a number of epithelial-derived cancers such as ovarian, endometrial, breast, renal, lung, colorectal and pituitary. The antibody received orphan drug designation for ovarian cancer in the US, EU and Switzerland.

Farletuzumab is currently being developed as a monoclonal antibody for its potential treatment of ovarian and lung cancers. An Investigational New Drug (IND) application was opened for MORAb-003 in 2005. A Phase 1 study was conducted at Memorial Sloan Kettering Cancer Center. A multi-institutional Phase 2 study in platinum-sensitive ovarian cancer of Farletuzumab in combination with the chemotherapy regimen carboplatin plus taxane was performed. This study led to an ongoing randomized, double-blind, placebo-controlled Ph3 study (FAR-131) in platinum-sensitive relapsed ovarian cancer that is being conducted globally in approximately 30 countries.  For more information about this on-going Phase III study, click here.

Recently, a new study testing farletuzumab in first line nonsmall cell lung adenocarcinoma (NSCLC) in combination with standard-of-care has been initiated.  This study is testing farletuzumab in patients with FRA positive NSCLC who are diagnosed using an FRA immunohistochemical analysis of patients' biopsied tissue. Patients with FRA positive tumors are then treated with a physician's choice of one of the standard chemotherapy drug regimens carboplatin or cisplatin plus pemetrexed or taxane. The study is designed as a randomized, double-blind placebo-controlled study to assess the efficacy of farletuzumab in combination therapy with the current standards of care as determined by progression-free survival in patients with advanced disease. Secondary objectives include safety and overall survival benefit of patients treated with the antibody versus placebo. The patient population includes individuals who are FRA-positive with advanced NSCLC that have not received any prior radiation or chemotherapy for their disease. It is estimated that about three-quarters of adenocarcinomas of the lung are FRA-positive.