In documents posted to the FDA's website Tuesday ahead of a July 9 advisory panel meeting, agency staff said Eli Lilly's investigational lung cancer drug necitumumab extended overall survival, but also raised the risk of potentially fatal thromboembolic events. The company is seeking US approval for the recombinant human IgG1 monoclonal antibody in combination with cisplatin and gemcitabine, which it markets as Gemzar, as a first-line treatment for patients with locally advanced or metastatic squamous non-small-cell lung cancer (NSCLC).
Eli Lilly's submission was supported by data from the Phase III SQUIRE trial of 1093 patients with late-stage squamous NSCLC who had received no prior therapy for metastatic disease. In the trial, patients who received necitumumab in combination with gemcitabine plus cisplatin exhibited a mean overall survival of 11.5 months, versus 9.9 months for patients who received gemcitabine and cisplatin alone.
Meanwhile, 9 percent of patients in the necitumumab arm experienced thromboembolic events, versus 5 percent in the standard chemotherapy group. The agency noted that although the drug has a similar safety profile as other comparable therapies, the increased risk of blood clots "in this already high-risk population is of concern."
The FDA will issue a final decision regarding whether to clear necitumumab by the end of the year. If approved, analysts have projected revenue of $567 million to $582 million by 2020.
Earlier this year, Eli Lilly entered into an agreement with Merck & Co. to evaluate immuno-oncology combination regimens for multiple cancer types, including to test necitumumab with Merck's anti-PD-1 therapy Keytruda (pembrolizumab) in a Phase I/II NSCLC trial.
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