Lilly's lung cancer drug seen as risky by FDA—but will that matter?
- Necitumumab (IMC-11F8) is a recombinant human IgG1 monoclonal antibody designed to target the human epidermal growth factor receptor 1 (EGFR).
- This drug is being tested for treatment of squamous non-small cell lung cancer (NSCLC), where there continues to be an unmet medical need.
- In one study, 9% of necitumumab-treated patients experienced blood clots, compared with 5% of patients treated only with chemotherapy.
The results of the phase III SQUIRE study showed that patients treated with necitumumab plus chemotherapy (gemcitabane plus cisplatin) compared with chemotherapy only had a longer overall survival (11.5 monts versis 9.9 months), and according to the article overviewing the study published in The Lancet, the results were significant. At the same time there was a high rate of adverse events (AEs), with 72% of patients in the necitumumab group experiencing a grade 3 or worse AE.
The FDA is cautious because of this high level of AEs, especially the clotting; however, it's important to remember that the patient population in question is very sick and likely to die within a year regardless, given the currently available treatment options for patients with stage 4 squamous NSCLC. By the end of this year, the FDA will make a decision to determine whether necitumumab is approvable, and considering that the agency has shown a willingness to approve drugs for unmet medical needs, it might be willing to look past some of these adverse events.