Fast Track for Merrimack Lung Cancer Drug

FDA has granted Merrimack Pharmaceuticals fast track status for MM-121 (seribantumab) for treating patients with heregulin-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed following immunotherapy. Currently, Merrimack is conducting the SHERLOC trial, a global clinical study of seribantumab in combination with docetaxel or pemetrexed in heregulin-positive patients with NSCLC that is designed to support a future BLA submission. The company says the human monoclonal antibody was designed to target ErbB3 and phenotypically distinct heregulin-positive cancer cells within solid tumors. “Heregulin-positive cancer cells are characterized by their ability to escape the effects of targeted, cytotoxic and anti-endocrine therapies and potentially contribute to rapid clinical progression in patients whose tumor cells test positive for heregulin as detected by RNA-ISH,” it says.