Alimta Receives Expanded Indication
June 4, 2018 – The U.S. FDA has approved an expanded indication for Alimta® (pemetrexed for injection), manufactured by Eli Lilly. The drug is now indicated, when used in combination with carboplatin and Merck’s Keytruda® (pembrolizumab), as an initial treatment for patients who have metastatic nonsquamous non-small cell lung cancer (NSCLC), regardless of their PD-L1 expression status.
Alimta and Keytruda are the first and only combination of chemotherapy and immunotherapy granted FDA approval as first-line treatments for metastatic nonsquamous NSCLC. Because the expanded indication was granted under an accelerated approval, additional trials may be required to maintain the combination’s status as an FDA-approved first-line treatment.
In a clinical study, progression-free survival in patients treated with Alimta, Keytruda, and carboplatin was 13 months, compared to 8.9 months with Alimta and carboplatin alone. The objective response rate also improved: 55% with the three-drug combination versus 29% with Alimta and carboplatin.
Recommended dosing is 500mg/m2 via intravenous infusion on Day 1 of a 21-day cycle in patients with creatinine clearance of 45 mL/minute or more. Patients who receive Alimta should also be treated with folic acid, vitamin B12, and dexamethasone.
First approved by the FDA in 2004, Alimta carries several indications for the treatment of NSCLC, as well as one indication for the treatment of mesothelioma.
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