Lilly issues statement on FDA Advisory Committee review of necitumumab

Lilly has issued a statement in response to the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee’s review of necitumumab.

Lilly is seeking initial approval of necitumumab in combination with gemcitabine and cisplatin for use in first-line treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC).

“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,” said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology. “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.”

Trial data suggested that necitumumab might increase the likelihood of thromboembolic events

Squamous NSCLC is a devastating and difficult-to-treat form of lung cancer. The five-year survival rate for patients with metastatic disease is less than 5%. Necitumumab in combination with gemcitabine and cisplatin is the first regimen to show a significant improvement in overall survival over chemotherapy alone, specifically in the first-line setting.

However, trial data suggested that necitumumab might increase the likelihood of thromboembolic events and raised concerns with the FDA. The FDA is in the process of reviewing the benefit-risk profile of the drug and is expected to make a decision on Lilly’s biologics license application later this year.