Labeling Extended for Keytruda
August 5, 2016 – The FDA approved a new indication for Merck’s Keytruda (pembrolizumab) under the accelerated approval process. Keytruda is approved for patients who have recurring or metastatic head or neck squamous cell carcinoma (HNSCC). It is an intravenous (IV) drug that will be used during or following platinum-based therapy that is not controlling the cancer. A humanized monoclonal antibody, Keytruda blocks a protein (PD-L1), to enhance immune response. It was previously indicated for treating unresectable or metastatic melanoma and metastatic non-small cell lung cancer (NSCLC) that expresses PD-L1 and that has progressed during or after platinum-containing chemotherapy. NSCLC patients must be tested for PD-L1 before beginning Keytruda. To treat HNSCC, 200mg of Keytruda is infused over a 30-minute period once every three weeks. HNSCC patients will not need PD-L1 testing.
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 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.