FDA panel to review Lilly's lung cancer combo drug
- On July 9, an FDA panel will review use of Eli Lilly's necitumumab, combined with gemcitabine and cisplatin, for treatment of non-small cell lung cancer (NSCLC).
- If approved, necitumumab will be Lilly's third treatment for lung cancer.
- Analysts at Cowen & Co estimate that necitumumab could generate $500 million in revenues per year by 2020.
NSCLC accounts for almost 85% of all lung cancers and is especially deadly. In fact, according to the American Cancer Society, the five-year survival rate for stage 4 NSCLC is only 1%.
Recently reported results from the SQUIRE study, the largest phase III study of patients with stage 4 squamous cell NSCLC, showed that necitumumab combined with gemcitabine and cisplatin significantly improved overall survival in these patients—by 16%, resulting in a median overall survival period of 11.5 months.
Given the fact that there are few medical options for these patients, these results bode well. There is a good chance that Lilly will receive approval for its latest marketing application.