{"answer":{"query":"Keytruda","resolved_as":"applications","packages":2,"applications":["BLA125514"],"identity":{"application_numbers":["BLA125514"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"INJECTION, SOLUTION","untrusted":true}],"marketing_start":{"earliest":"2015-01-15","latest":"2019-08-01","packages_with_a_start_date":2}},"label_history":{"events_total":127,"non_cmc_events":126,"counts_by_class":{"EFFICACY":109,"LABELING":17},"cmc_events":1,"recent_non_cmc_events":[{"application":"BLA125514","submission_no":191,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-10-16","documents":[{"type":"Label","date":"2026-10-27","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125514s191lblCorrected.pdf","untrusted":true}},{"type":"Letter","date":"2026-10-27","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/125514s191ltrCorrected.pdf","untrusted":true}}],"fact_id":"4756c14a9bcb1ce192a7a36e"},{"application":"BLA125514","submission_no":194,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-07-10","documents":[{"type":"Letter","date":"2026-07-13","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/125514Orig1s194ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-07-15","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125514s194lbl.pdf","untrusted":true}}],"fact_id":"44fa18bba2e42f18f7930261"},{"application":"BLA125514","submission_no":187,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-06-24","documents":[{"type":"Letter","date":"2026-06-26","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/125514Orig1s187ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-06-29","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125514s187lbl.pdf","untrusted":true}}],"fact_id":"42390786cb4e21c5c7bb9d33"},{"application":"BLA125514","submission_no":192,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-06-12","documents":[{"type":"Label","date":"2026-06-16","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125514s192lbl.pdf","untrusted":true}},{"type":"Letter","date":"2026-06-26","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/125514Orig1s192ltr.pdf","untrusted":true}}],"fact_id":"f6babf2703a4e5d4751b761e"},{"application":"BLA125514","submission_no":190,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-05-12","documents":[{"type":"Letter","date":"2026-05-13","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/125514Orig1s190ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-05-18","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125514s190lbl.pdf","untrusted":true}}],"fact_id":"05840876bfee362fc6e4c529"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":1,"te_code_counts":{"NOT_PROVIDED":1},"marketing_status_counts":{"Prescription":1},"meaning":"raw FDA codes; the therapeutic equivalence code says whether FDA rates a generic as substitutable, and what that means for a given prescription is for a pharmacist or prescriber","products":[{"application":"BLA125514","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"KEYTRUDA","untrusted":true},"form":{"text":"SOLUTION;INTRAVENOUS","untrusted":true},"strength":{"text":"100MG/4ML (25MG/ML)","untrusted":true}}]},"assistance_and_offers":{"programs_listing_this_drug":[{"name":{"text":"Merck Helps (Merck Patient Assistance Program)","untrusted":true},"type":"manufacturer","url":"https://www.merckhelps.com/","status":null,"needs_status_check":false,"has_offer":false},{"name":{"text":"Keytruda Patient Assistance (Merck)","untrusted":true},"type":"manufacturer","url":"https://www.keytruda.com/financial-support/","status":null,"needs_status_check":false,"has_offer":false},{"name":{"text":"HealthWell Foundation","untrusted":true},"type":"nonprofit","url":"https://www.healthwellfoundation.org/","status":{"state":"limited","effective":null,"applies_to":{"text":"HealthWell Foundation disease funds, as listed on the homepage when read","untrusted":true},"detail":{"text":"The HealthWell Foundation homepage lists disease funds as Open or Closed when read. Closed funds include Type 2 Diabetes, Migraine and Multiple Sclerosis - Medicare Access; open funds include Multiple Myeloma - Medicare Access, which the page says offers up to $8,000 in prescription drug copayment or Medicare Part B premium assistance. The page carries no fund-level date; the status is as of the read.","untrusted":true},"read_on":"2026-11-07T07:23:55.567Z","source_url":"https://www.healthwellfoundation.org/","proof_state":"verified"},"needs_status_check":true,"has_offer":false},{"name":{"text":"Good Days (formerly Chronic Disease Fund)","untrusted":true},"type":"nonprofit","url":"https://www.mygooddays.org/","status":null,"needs_status_check":false,"has_offer":false}],"manufacturer_offers":[],"note":"A program that lists a drug has not decided anything about any person: each program decides who qualifies, and a status other than open means it may not take new patients. Offers change and expire; read each offer's source and stated end date. A price figure is what the page states, not a quote."},"spending":{"reported_under":{"generic":{"text":"Pembrolizumab","untrusted":true},"brand":{"text":"Keytruda","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":57022095.4,"claims":5573,"beneficiaries":959,"average_spending_per_claim_usd":10231.849166,"fact_id":"2ae728e13249c30c2e859dd4"},{"year":2021,"gross_spending_usd":68680805.63,"claims":6392,"beneficiaries":1050,"average_spending_per_claim_usd":10744.806888,"fact_id":"a7b0d8d0b4b8946188285aa0"},{"year":2022,"gross_spending_usd":91147954.99,"claims":7915,"beneficiaries":1335,"average_spending_per_claim_usd":11515.850283,"fact_id":"9afbba8f1a142983d919ab1a"},{"year":2023,"gross_spending_usd":116820430.15,"claims":9668,"beneficiaries":1523,"average_spending_per_claim_usd":12083.205435,"fact_id":"c144fe3f8a1650980da979aa"},{"year":2024,"gross_spending_usd":140055039.83,"claims":11882,"beneficiaries":1906,"average_spending_per_claim_usd":11787.160396,"fact_id":"07033914f18dc799d3b998d9"}],"rebate_caveat":"CMS's dataset states spending is gross drug cost and does not reflect manufacturers' rebates or other price concessions.","not_a_patient_price":"Spending is the total paid by Medicare, plans and beneficiaries for the drug's claims, not what a patient pays.","meaning":"a drug-level aggregate of Medicare Part D claims for all manufacturers combined; not a formulary, not coverage","source":{"dataset":{"text":"data-year-2024, modified 2026-06-25","untrusted":true},"link":{"text":"https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-medicaid-spending-by-drug/medicare-part-d-spending-by-drug","untrusted":true}}},"biologic_status":{"products":[{"application":"BLA125514","status":"Reference","name":{"text":"Keytruda","untrusted":true},"proper_name":{"text":"pembrolizumab","untrusted":true},"license_status":"Licensed","approval_date":"2014-09-04","reference_product":null,"interchangeable_date":null,"biosimilars_listed":0,"interchangeables_listed":0,"biosimilars":[],"interchangeables":[],"purple_book_version":"purplebook-2026-10","read_on":"2026-11-07T07:33:31.186Z","fact_id":"208dfc8037d9db63c1ab0cc3"}],"reading":"what the FDA Purple Book lists on its read date, a record and not a forecast of launch or substitution"},"payment_limit":{"codes":[{"hcpcs":"J9271","quarter":"2026Q4","effective":"October 1, 2026 through December 31, 2026","payment_limit_usd":62.253,"dosage_descriptor":{"text":"1 MG","untrusted":true},"packages_matched":2,"read_on":"2026-11-07T07:31:28.000Z","source_url":{"text":"https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files","untrusted":true},"fact_id":"e7dfb100c1218badee858eca"}],"codes_total":1,"meaning":"a Medicare Part B payment ceiling for providers billing a HCPCS code, per dosage descriptor unit; not a price a patient pays, and the presence of a code does not indicate that Medicare covers a product"},"orphan_designation":{"ingredients":[{"ingredient":{"text":"pembrolizumab","untrusted":true},"designation_count":22,"approved_count":17,"recent":[{"designated":"2026-06-06","use":{"text":"treatment of neuroendocrine prostate cancer (NEPC)","untrusted":true},"status":"Designated","sponsor":{"text":"Merck, Sharp & Dohme LLC.","untrusted":true},"approved":false},{"designated":"2025-01-03","use":{"text":"treatment of recurrent respiratory papillomatosis","untrusted":true},"status":"Designated/Designation Withdrawn or Revoked","sponsor":{"text":"Massachusetts General Hospital","untrusted":true},"approved":false},{"designated":"2019-10-09","use":{"text":"Treatment of Biliary Tract Carcinoma","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"MSD International Business GmbH","untrusted":true},"approved":true},{"designated":"2017-10-03","use":{"text":"Treatment of Small Cell Lung Cancer","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"MSD International Business GmbH","untrusted":true},"approved":true},{"designated":"2017-06-15","use":{"text":"Treatment of esophageal carcinoma","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"MSD International Business GmbH","untrusted":true},"approved":true}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"a8de0ce566970b1e4dedf070"}],"reading":"a designation is not an approval and not a statement that the drug treats the condition; status is the FDA database's own"},"medicaid_state_utilization":{"year":2025,"states_with_data":4,"all_states_medicaid_reimbursed_usd":5229874.05,"all_states_medicaid_paid_prescriptions":499,"top_states":[{"state":"LA","medicaid_paid_prescriptions":275,"medicaid_reimbursed_usd":3303953.07,"total_reimbursed_usd":3340889.94,"packages":1,"covers":"fee_for_service_only","fact_id":"5c809b85a1e0b92766174998"},{"state":"ND","medicaid_paid_prescriptions":87,"medicaid_reimbursed_usd":865972.42,"total_reimbursed_usd":929125.31,"packages":1,"covers":"fee_for_service_only","fact_id":"642ae5a84769158e5cfc2253"},{"state":"TN","medicaid_paid_prescriptions":71,"medicaid_reimbursed_usd":691430.71,"total_reimbursed_usd":691430.71,"packages":1,"covers":"all_record_types","fact_id":"2ce15397448e60474437a7f6"},{"state":"CO","medicaid_paid_prescriptions":66,"medicaid_reimbursed_usd":368517.85,"total_reimbursed_usd":368517.85,"packages":1,"covers":"fee_for_service_only","fact_id":"d317224877f99c497a375fed"}],"unlabelled_state_code_xx":null,"built_from_facts":4,"facts_fee_for_service_only":3,"older_year_facts_not_used":90,"dataset":"State Drug Utilization Data 2025","read_on":"2026-11-07T22:41:44.201Z","reading":"Medicaid prescriptions and reimbursement by state (CMS State Drug Utilization Data). 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See the provenance tool for each fact's licence label."},"unknown":[{"code":"NO_DATA","field":"price","reason":"no NADAC price, negotiated price or federal upper limit for these packages"},{"code":"NO_DATA","field":"generic_entry:BLA125514","reason":"no generic-entry fact for this application: no patent or exclusivity is listed for it in the Orange Book edition read, so no date is stated"},{"code":"NO_DATA","field":"generic_entry","reason":"no application of this drug has a generic-entry fact; no date is stated"},{"code":"NO_DATA","field":"recalls","reason":"no FDA enforcement report naming a package of these applications is recorded"},{"code":"NO_DATA","field":"supply","reason":"no FDA shortage row and no termination date for these packages"},{"code":"NO_DATA","field":"trials","reason":"no ClinicalTrials.gov record set for this drug's ingredient is in the edition"},{"code":"NO_DATA","field":"policy","reason":"no Federal Register event in the edition names this drug or its programs"},{"code":"NO_DATA","field":"rems","reason":"no REMS@FDA program is tied to these applications in the edition (most drugs have none)"},{"code":"NO_DATA","field":"controlled_schedule","reason":"no DEA schedule entry matched this drug's ingredient in the edition"},{"code":"NO_DATA","field":"safety_communication","reason":"no FDA Drug Safety Communication names this drug's ingredient in the edition"}],"disclaimer":"OmniRx is a reference layer of dated public facts, not clinical advice and not a guarantee of price, coverage or eligibility. Each answer lists the facts it rests on."}