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.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.