Washington, July 11, 2015
An advisory panel to the U.S. Food and Drug Administration effectively supported approval of Eli Lilly & Co’s experimental lung cancer drug necitumumab on Thursday but recommended measures be taken to mitigate the drug’s risks.
The panel did not officially vote but an informal poll taken by the FDA indicated most members believe the benefits of the drug outweigh the risks. The FDA is not obliged to follow the advice of its advisers but generally does so.
In a clinical trial, the drug 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.
“We are encouraged by the Committee’s constructive discussion,” said Dr. Richard Gaynor, senior vice president of product development and medical affairs for Lilly’s oncology division. “We look forward to working closely with the FDA as they continue their review.”
Necitumumab is a second-generation monoclonal antibody for patients with stage IV squamous non-small cell lung cancer.
In a 1,093-patient clinical trial, patients who received necitumumab together with the chemotherapy drugs gemcitabine and cisplatin survived an average of 11.5 months compared with 9.9 months for patients who received gemcitabine and cisplatin alone.
Most panel members described the survival benefit as modest but meaningful and in line with the benefit conferred by other FDA-approved drugs.
Lilly noted that the five-year survival rate for patients with advanced squamous NSCLC is less than 5 percent.
“Little progress has been made over the last two decades, particularly in the first-line setting,” the company said.
Lilly’s shares were up 8 cents at $87.33 on Thursday afternoon on the New York Stock Exchange. Reuters
