New Indication for Keytruda
October 24, 2016 - The US FDA approved Keytruda® (pembrolizumab), manufactured by Merck. Keytruda’s new indication is for the initial therapy of metastatic non-small cell lung cancer (NSCLC) without epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations, but expressing 50% or more of programmed death ligand 1 (PD-L1). The presence of PD-L1 must be verified by an FDA-approved diagnostic test. At this same time new labeling was announced and additional information was added from studies of patients who have metastatic NSCLC that produces at least 1% of PD-L1 and that advances despite treatment with chemotherapy regimens containing platinum. For NSCLC, 200mg of Keytruda is given once every three weeks as a 30-minute IV infusion. Previous approvals for Keytruda include melanoma and head and neck cancers.
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.