YM Biosciences, a cancer-focused product development company, has received approval to market nimotuzumab in Mexico. The company also announced that it has enrolled the first two patients in a clinical trial evaluating nimotuzumab in patients with brain tumors from non-small cell lung cancer (NSCLC).
Mexico is the 21st country to approve nimotuzumab. The drug is a monoclonal antibody that targets the epidermal growth factor receptor (EGFR), which certain tumors rely on in order to grow. Nimotuzumab is similar to ImClone Systems‘ Erbitux or Roche‘s Tarceva. In clinical trials, nimotuzumab has demonstrated efficacy without producing the severe toxicities (such as skin rash) associated with some of its peers. Nimotuzumab has been found to target cancer cells while sparing healthy tissue. Mexico approved nimotuzumab for use in treating squamous cell carcinoma of the head and neck, adult brain cancer, and pediatric brain cancer. It will be commercialized under the name Vecthix.
The multinational clinical trial will compare a combination of nimotuzumab plus whole-brain radiation therapy (WBRT) to WBRT alone in patients with brain metastases from NSCLC. Researchers plan to enroll 88 patients for 12 months of treatment, plus a 12-month follow-up period. The first two patients were enrolled in Montreal, Canada.
Nimotuzumab is currently in 32 clinical trials around the world, to treat lung esophageal pancreatic, prostate cancer, cervical, and breast cancers. More than 5,000 patients worldwide have reportedly been treated with nimotuzumab. The U.S. Food and Drug Administration has designated it an Orphan Drug for adult and pediatric brain cancer.