FDA Holds Constructive Talks On Benefit-Risk Profile Of Cancer Drug: Eli Lilly

(RTTNews) - Eli Lilly and Co (LLY) on Thursday said a panel of the U.S. Food and Drug Administration held a "constructive discussion" on the benefit-risk profile of its investigational cancer drug necitumumab.

According to Eli Lilly, the FDA Oncologic Drugs Advisory Committee's discussion focused on necitumumab in combination with gemcitabine and cisplatin for use in first-line treatment of patients with advanced 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, 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."

The FDA is not bound to follow the recommendations of its panel, but usually does so.

Necitumumab is a second-generation monoclonal antibody for patients with stage IV squamous non-small cell lung cancer. The drug 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.

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 five percent.

In a clinical trial, Necitumumab reportedly improved overall survival by an average of 1.6 months, but also increased the risk of sometimes fatal blood clots and potentially deadly electrolyte imbalances.

The FDA is expected to make a decision on Lilly's biologics license application for necitumumab later this year.

LLY closed Thursday at $87.48, up $0.23 or 0.26%, on the NYSE. In after hours, the stock gained $0.10 or 0.12%.