Specifically, NICE's FAD recommends Alimta as an option for the maintenance treatment of people with locally advanced or metastatic non-small cell lung cancer with other than predominantly squamous cell (nonsquamous) histology if disease has not progressed immediately following platinum-based chemotherapy first-line chemotherapy.
Eli Lilly said that this recommendation is the second step in a three-step approval process; NICE expects to issue its final guidance this summer.
The NICE recommendation for Alimta was based on data that demonstrated it improved overall survival for advanced nonsquamous NSCLC cancer patients in the maintenance setting. The appraisal committee concluded that the evidence submitted fulfilled the end of life criteria.
The global, multicenter, double-blind Phase III trial compared efficacy with respect to overall survival of Alimta plus best supportive care versus placebo plus best supportive care in 663 patients with stage IIIB/IV NSCLC whose disease had not progressed after four cycles of platinum-based induction chemotherapy. Alimta was not included among the induction regimens studied in the maintenance trial. Myelosuppresion is usually the dose-limiting toxicity with Alimta therapy.
In the trial, the patients were treated with Alimta (500mg/m2 on day one of each 21-day cycle) plus best supportive care or placebo plus best supportive care. All patients were supplemented with vitamin B12, folic acid and dexamethasone.
John Johnson, president of oncology at Lilly, said: "This decision is a promising step toward recognising the value of Alimta for patients, payer organisations and doctors. Most importantly, it means more advanced nonsquamous NSCLC patients may have access to treatment that can potentially prolong their lives."