Posted from: Friday, July 06, 2018 - 04:11 PM - Present

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.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

 

Last Updated Friday, September 21, 2018 - 10:18 PM.