New Indication for Keytruda
September 22, 2017 – The U.S. FDA has approved a tenth indication for Keytruda® (pembrolizumab), manufactured by Merck. Under the new indication, Keytruda is approved for the treatment of recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma that expresses PD-L1. To be eligible for treatment with Keytruda under the new indication, patients must have disease progression during or after treatment with at least two other therapies, including chemotherapy containing fluoropyrimidine and platinum-based drugs. The patients’ tumors must also test positive for PD-L1 through the Dako PD-L1 IHC 22C3 pharmDx companion diagnostic test.
Keytruda, a human programmed death receptor-1 (PD-1)-blocking antibody, holds FDA approval for numerous indications to treat multiple forms of cancer, either as a monotherapy or in combination with other drugs. It is the first drug to receive FDA approval for treating colorectal cancer and any solid tumors that are microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), regardless of the tumors’ primary site of origin.
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.