Recently, the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC), whose main function is to evaluate both safety and effectiveness of human drugs (already in the market or under investigation) for cancer treatment met with Eli Lilly & Company’s managers and leading scientists to discuss their potential support to introduce necitumumab in combination with chemotherapy drugs, gemcitabine and cisplatin, as a first line-treatment for advanced squamous non-small cell lung cancer (NSCLC). Although the ODAC did not vote on immediate necitumumab approval, this is a in fact a possibility to occur until the end of the year, with the committee recognizing the potential added benefits of necitumumab as a first-line treatment for advanced squamous NSCLC.
NSCLC is the most common type of lung cancer, affecting approximately 85% of all lung cancer patients. Squamous NSCLC, however, affects fewer patients but it is very difficult to treat, with patients with advanced squamous NSCLC, i.e. when the disease already progress to a metastatic state, exihibiting a five-year survival rate of less than five percent. Combining necitumumab with gemcitabine and cisplatin was shown to significantly improve patients overall survival, when compared to chemotherapy alone.
Necitumumab is designed to bind the extracellular domain of human epidermal growth factor receptor 1 (EGFR), blocking its interaction with its ligands (it is established that EGFR expression is selectively and highly increased in tumor cells, contributing to malignant progression, enhancing the formation of new blood vessels (a process called angiogenesis and important to allow tumors expansion and growth) and block cell death.
Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology noted, “We are encouraged by the Committee’s constructive discussion on the benefit-risk profile of necitumumab as few advances have been made over the past two decades in the first-line treatment of advanced squamous NSCLC, leaving a significant unmet medical need. We believe necitumumab with gemcitabine and cisplatin represents a meaningful advance in the search for a new first-line treatment option and look forward to working closely with the FDA as they continue their review.”
Eli Lilly & Company’s is a leader health-care company focusing on developing and make accessible new medicines for people in need. The Lilly Oncology Division is devoted to support cancer patients throughout their disease.