Posted from: Friday, October 30, 2015 - 12:16 PM - Present

Keytruda Approved for the Treatment of Non

October 2, 2015 – The U.S. Food and Drug Administration (FDA) granted accelerated approval to for Keytruda (pembrolizumab).  Keytruda is manufactured by Merck and indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express programmed death receptor – ligand (PD-LI) as determined by an FDA-approved test and who have disease progression on or after platinum-containing chemotherapy. Originally approved on September 4, 2014 for the second-line or third-line treatment of patients with unresectable or metastatic melanoma, Keytruda is a humasn programmed death receptor – 1 (PD-1) blocking antibody that helps the body’s immune system attack cancer cells.

Prior to receiving Keytruda, patients with epidermal growth factor receptor (EGFr) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations should have disease progression on an FDA-approved therapy for these aberrations.  The FDA also approved a companion pharmacogenetic test that detects PD-L1 expression in non-small cell lung tumors.

Continued approval of Keytruda for the treatment of NSCLC and melanoma is dependent on confirmatory trials that demonstrate a clinical benefit in the patients that utilize them. Recommended dose for the indications listed above is 2mg/kg by intravenous infusion every three weeks for NSCLC.

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 regular mail or by fax.

Actual drug patent expiration dates and a 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. All trademarks are the property of their respective owners.

*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, October 11, 2019 - 06:37 PM.