An FDA advisory panel indicated Thursday that the benefits of Eli Lilly's investigational lung cancer drug necitumumab outweigh its risks. Most panel members described the drug's survival benefit as modest, yet meaningful, and in line with other FDA-approved therapies, but they suggested measures should be adopted to mitigate its potential risks.
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). Earlier this week, an FDA staff report noted that while necitumumab extended overall survival, the drug also raised the risk of potentially fatal thromboembolic events.
Eli Lilly's submission was supported by data from the Phase III SQUIRE study 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 those given gemcitabine and cisplatin alone. The FDA staff report also noted that results from the INSPIRE trial, whose enrolment was halted in 2011 amid safety concerns related to thromboembolism, found that adding necitumumab to Eli Lilly's Alimta (pemetrexed) and cisplatin did not improve overall survival or progression-free survival in patients with metastatic nonsquamous NSCLC.
Commenting on the recommendation, Richard Gaynor, senior vice president for product development and medical affairs at Eli Lilly's oncology division, said the company was "encouraged by the committee's constructive discussion on the benefit-risk profile of necitumumab." He noted 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," and that the combination of necitumumab plus gemcitabine and cisplatin "represents a meaningful advance in the search for a new first-line treatment option."
The FDA is expected to make a decision on the approval of necitumumab later this year.
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