Additional Indication for Keytruda
March 14, 2017 – The U.S. FDA approved Keytruda® (pembrolizumab) for use in certain patients with classical Hodgkin lymphoma (cHL). Keytruda, manufactured by Merck receive a new indication for use in patients whose cHL either has not responded to other therapies or has recurred despite at least three previous treatments. For cHL, the recommended adult dose is 200mg. For children, the dose is 2mg/kg up to a maximum of 200mg. Keytruda is given as an intravenous (IV) infusion once every three weeks until cHL gets worse or the drug’s side effects become unbearable. If cHL does not progress, treatment can continue for as long as two years. Originally approved in 2014 to treat advanced melanoma, Keytruda also has indications for non-small cell lung cancer and head and neck cancers. It is a human programmed death receptor-1 (PD-1)-blocking antibody that boosts the immune system’s ability to attack cancer cells.
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.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. 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 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.