Pembrolizumab

For Endometrial Carcinoma, administer KEYTRUDA QLEX: in combination with carboplatin and paclitaxel regardless of MMR or MSI status, or in combination with lenvatinib 20 mg orally once daily for pMMR or not MSI-H tumors, or as a single agent for MSI-H or dMMR tumors. See Full Prescribing Information for dosage modifications for adverse reactions and preparation and administration instructions. ( 2.4 , 2.5 ) 2.1 Patient Selection See information on FDA-authorized tests for intravenous pembrolizumab. Information on FDA-authorized tests

for patient selection is available at: http://www.fda.gov/CompanionDiagnostics . Patient Selection for Single-Agent Treatment Select patients for treatment with KEYTRUDA QLEX as a single agent based on the presence of positive PD-L1 expression in: Stage III NSCLC who are not candidates for surgical resection or definitive chemoradiation . metastatic NSCLC . first-line treatment of metastatic or unresectable, recurrent HNSCC . previously treated recurrent locally advanced or metastatic esophageal cancer . recurrent or metastatic cervical cancer with disease progression on or after chemotherapy . For the MSI-H/dMMR indications, select patients for treatment with KEYTRUDA QLEX as a single agent based on MSI-H/dMMR status in tumor specimens .

for the drug administered in combination. Table 3: Recommended Specific Dosage Modifications for Adverse Reactions for KEYTRUDA QLEX in Combination with Axitinib Treatment Adverse Reaction Severity Dosage Modification ALT = alanine aminotransferase, AST = aspartate aminotransferase, ULN = upper limit normal KEYTRUDA QLEX in combination with axitinib Liver enzyme elevations Consider corticosteroid therapy ALT or AST increases to at least 3 times but less than 10 times ULN without concurrent total bilirubin at least 2 times ULN Withhold both KEYTRUDA QLEX and axitinib until resolution to Grades 0 or 1 Based on Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. Consider rechallenge with a single drug or sequential rechallenge with both drugs after recovery.