It seems US regulatory advisors are backing approval of Lilly’s lung cancer drug necitumumab despite safety concerns over the potentially inreased risk of deadly blood clots.
An informal poll undertaken at a US Food and Drug Administration advisory panel meeting reportedly shows most committee members believe the drug does indeed have a positive benefit-risk profile for patients with stage IV squamous non-small cell lung cancer.
Trial data shows that necitumumab improves survival by an average 1.6 months, but safety flags were raised after the incidence of thromboembolic events was found to be 9% in the group given Lilly’s drug compared to 5% in the control arm.
Richard Gaynor, who heads up product development and medical affairs for Lilly Oncology, says he is “encouraged” by the Committee's “constructive discussion” given that 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”.
A final decision from the US regulator is expected later this year.