Keytruda Label Expanded
December 18, 2015 – The U.S. Food and Drug Administration (FDA) approved Keytruda (pembrolizumab) for an expanded indication. Manufactured by Merck, Keytruda is a first-line treatment of patients with unresectable or metastatic melanoma and a human programmed death receptor-1 (PD-1)-blocking antibody that helps the body’s immune system attack cancer cells. Keytruda was originally approved on Septeeember 4, 2014, for the second- or third-line treatment of patients with unresectable or metastatic melanoma. In October 2015, the FDA provided an expanded approval of Keytruda as a later-line option for the treatment of certain patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express programmed death receptor-ligand1 (PD-L1) as determined by an FDA-approved test. The recommended dose for all indications is 2mg/kg by intravenous infusion every three weeks.
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
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.