Expanded Indication Approved for Alimta
January 30, 2019 – The U.S. FDA has granted full approval for an expanded indication for Alimta® (pemetrexed) injection, manufactured by Eli Lilly. The drug is now approved for use with platinum-based chemotherapy and Merck’s Keytruda® (pembrolizumab) to provide first-line treatment for patients who have metastatic nonsquamous non-small cell lung cancer (NSCLC) without epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
Alimta received accelerated approval for the indication in June 2018. The FDA’s full approval was contingent upon the results of further study that verified and described Alimta’s clinical benefit. In clinical trials, the overall response rate for patients who received Alimta with Keytruda and chemotherapy was 48%, compared to just 19% for patients who received Alimta with a placebo and chemotherapy. The median duration of response was 11.2 months with Alimta, Keytruda, and chemotherapy, versus 7.8 months for the placebo group.
When administered as part of a regimen that includes Keytruda and platinum-based chemotherapy, Alimta has a recommended dose of 500mg/m2 of body surface area, delivered via intravenous infusion over the course of ten minutes. It should be given on Day 1 of a 21-day cycle, after the administration of Keytruda and prior to the administration of chemotherapy. Patients should also receive dexamethasone, folic acid, and vitamin B12 as part of the treatment regimen.
Originally FDA approved in 2004, Alimta has four indications for the treatment of NSCLC and one for the treatment of mesothelioma.