WASHINGTON (Reuters) - Eli Lilly & Co.’s experimental lung cancer drug necitumumab improved overall survival by an average of 1.6 months but also increased the risk of sometimes fatal blood clots, according to a preliminary review by the U.S. Food and Drug Administration.
The FDA’s review was posted on its website on Tuesday ahead of July 9 meeting of outside experts who will discuss the drug and recommend whether it should be approved. The FDA usually follows the advice of its advisory panels.
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.
In the necitumumab group, 48 percent of patients experienced serious side effects compared with 38 percent of patients in the control group.
There were 66 deaths in the necitumumab group of which 15, or roughly 3 percent, were deemed drug-related. There were 57 deaths in the control group, of which 10, or about 2 percent, were considered drug-related.
Analysts on average expect the drug, if approved, to generate annual sales of $582 million by 2020, according to Thomson Reuters data.
Non-small cell lung cancer (NSCLC) accounts for roughly 85 percent of all lung cancer cases. The squamous form accounts for about 30 percent of NSCLC cases.
Lilly also tested the drug in patients with advanced non-squamous NSCLC. The study was closed prematurely due to an imbalance in the number of deaths attributed to potential thromboembolic events, or blood clots. There was no offsetting difference in overall survival.
The FDA is seeking the panel’s advice on whether the results of the non-squamous trial impact the benefit to risk assessment of the drug in squamous NSCLC.
The overall incidence of thromboembolic events was 9 percent in the squamous NSCLC trial compared with 5 percent in the control group. In the non-squamous trial the incidence was 11 percent compared with 6 percent in the control group.
Reporting by Toni Clarke in Washington; Editing by Andrea Ricci