FDA support for Lilly cancer drug comes down to unmet needs vs side effects
- Eli Lilly's necitumumab (IMC-11F8) is a recombinant human IgG1 monoclonal antibody designed to target the human epidermal growth factor receptor 1 (EGFR).
- Necitumumab has been developed for the treatment of stage 4 squamous non small-cell lung cancer (NSCLC).
- The FDA has taken a cautious approach to approving necitumumab because of an increased risk of blood clots in patients who take the drug; however, the general consensus is that the benefits outweigh the risks.
The results of the phase III SQUIRE study showed that patients treated with necitumumab plus chemotherapy (gemcitabane plus cisplatin) compared with chemotherapy only experienced longer overall survival (11.5 monts versis 9.9 months); however, in the study, 9% of necitumumab-treated patients experienced blood clots, compared with 5% of patients treated only with standard therapy.
While the FDA has asked Lilly to enact risk-management strategies to decrease the risk of adverse events, there is an unmet need for more therapeutic options. In fact, there has been little progress in developing therapies for stage 4 squamous NSCLC for a long period of time. And given the fact that the five-year survival rate for stage 4 squamous NSCLC is only 5%, increased survival of almost two months represents an improvement over existing treatment options and an important step in advancing treatment of advanced-stage NSCLC.