{"doi":"10.1002/pds.5745","title":"Use of pembrolizumab among older adults with cancer in the United States, before and after <scp>FDA</scp> approval of its tumor‐agnostic indication","abstract":"INTRODUCTION: Pembrolizumab, an anticancer immunotherapy agent, has received multiple approvals since its first approval by the U.S. Food and Drug Administration (FDA) in 2014. Limited data exist on its real-world use and shifts post tumor-agnostic approval in 2017 for the treatment of patients with any microsatellite instability-high/mismatch repair deficient (MSI-H/dMMR) solid tumors. This study analyzes pembrolizumab's pre and post-tumor-agnostic approval use among older U.S. adults, revealing its evolving role in oncology practice. METHODS: Using the Surveillance, Epidemiology and End Results (SEER)-Medicare data (2014-2019), we examined the cancer sites of pembrolizumab recipients before and after tumor-agnostic approval. Cancer sites were classified based on the timing of site-specific approvals (before/after tumor-agnostic approval) or no site-specific approval, and inclusion in MSI-H/dMMR clinical trials. RESULTS: The total number of pembrolizumab recipients increased from 4221 in the pre-agnostic period to 20 479 in the post-agnostic period. Pembrolizumab was used for a broad range of cancer types, including cancers that had no FDA-approved site-specific indications at the time of use (25.8% in pre- and 24.6% in post-agnostic periods). The proportion of pembrolizumab recipients receiving pembrolizumab for cancers with site-specific approvals before tumor-agnostic approval decreased from 77.3% to 70.8%. The proportion of pembrolizumab recipients receiving pembrolizumab for cancers that gained site-specific approvals following tumor-agnostic approval almost doubled (6.8% to 13.0%). The proportion of pembrolizumab recipients with cancers included in MSI-H/dMMR trials also doubled (12.3% to 25.5%) following tumor-agnostic approval. CONCLUSIONS: Pembrolizumab use has expanded over time among older adults with cancer, extending beyond those with FDA-approved site-specific indications.","journal":"Pharmacoepidemiology and Drug Safety","year":2023,"id":387311,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":1,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9469,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2023-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":225094,"name":"Lindsey Enewold","orcid":"0000-0003-0452-5771","position":1,"is_corresponding":false},{"id":420904,"name":"Michael T. Halpern","orcid":"0000-0001-8514-6313","position":2,"is_corresponding":false},{"id":1156470,"name":"Chris Zeruto","orcid":null,"position":3,"is_corresponding":false},{"id":218029,"name":"Angela B. Mariotto","orcid":"0000-0003-2423-1834","position":4,"is_corresponding":false},{"id":1156102,"name":"Yoon Duk Hong","orcid":"0000-0002-9548-5770","position":0,"is_corresponding":true}],"reference_count":5,"raw_metadata":null,"created_at":"2026-07-19T01:18:04.706547Z","pmid":"38156547","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}