Eli Lilly has received the European Commission approval for the use of Alimta (pemetrexed for injection) as monotherapy. It is for maintenance treatment of patients with other than predominantly squamous cell histology in metastatic non-small cell lung cancer (NSCLC), whose disease has not progressed immediately following platinum-based chemotherapy.
The trial compared efficacy with respect to overall survival of pemetrexed 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). Pemetrexed was not included among the induction regimens studied in the maintenance trial. The trial supported two previous studies looking at the use of histology to tailor treatment for patients with advanced, other than predominantly squamous NSCLC.
Patients in the trial were treated with pemetrexed (500 mg/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.
This latest approval for pemetrexed follows an initial positive opinion issued by the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) on May 29, 2009. It also followed the recent approval by the FDA of pemetrexed for maintenance therapy in advanced, nonsquamous NSCLC patients, whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
Richard Gaynor, Vice President, cancer research and global oncology platform leader at Lilly, said: The idea behind Alimta as maintenance therapy for nonsquamous, non-small cell lung cancer is to treat patients immediately following their initial course of therapy, in an effort to prolong survival,
The study that led to this approval was the first that showed improved overall survival in the maintenance setting for NSCLC. This was also the third trial to show the benefit of tailoring ALIMTA treatment to the nonsquamous NSCLC patient population, he added.