{
 "query": "durvalumab",
 "ingredient": "durvalumab",
 "slug": "durvalumab",
 "rxcui": "1919503",
 "brands": [
  "Imfinzi"
 ],
 "names": [
  "durvalumab"
 ],
 "classes": [
  {
   "id": "L01FF",
   "name": "PD-1/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors"
  }
 ],
 "alternatives": [
  "atezolizumab",
  "avelumab",
  "cemiplimab",
  "dostarlimab",
  "nivolumab",
  "pembrolizumab",
  "retifanlimab",
  "tislelizumab",
  "toripalimab"
 ],
 "label": {
  "route_mode": "INTRAVENOUS",
  "route_counts": {
   "INTRAVENOUS": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "is a programmed death-ligand 1 (PD-L1) blocking antibody indicated: \u2022 in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, for the treatment of adult patients with resectable (tumors \u2265 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. ( 1.1 ) \u2022 as a single agent, for the treatment of adult patients with unresectable, Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. ( 1.1 ) \u2022 in combination with tremelimumab-actl and platinum-based chemotherapy, for the treatment of adult patients with metastatic NSCLC with no sensitizing EGFR mutations or ALK genomic tumor aberrations. ( 1.1 ) \u2022 as a single agent, for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. ( 1.2 ) \u2022 in combination with etoposide and either carboplatin or cisplatin, as first-line t...",
  "contraindications": "None. None. ( 4 )",
  "warnings_and_cautions": "\u2022 Immune-Mediated Adverse Reactions ( 5.1 ) \u2218 Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, immune-mediated nephritis and renal dysfunction, solid organ transplant rejection, and immune-mediated pancreatitis. o Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. o Withhold or permanently discontinue based on severity and type of reaction. \u2022 Infusion-Related Reactions: Interrupt, slow the rate of infusion, or permanently discontinue IMFINZI based on the severity of the reaction. ( 5.2 ) \u2022 Complications of Allogeneic HSCT: Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody. ( 5.3 ) \u2022 Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception. ( 5....",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are discussed in greater detail in other sections of the labeling. \u2022 Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.1) ]. \u2022 Infusion-Related Reactions [see Warnings and Precautions (5.2) ]. IMFINZI in Combination with Chemotherapy \u2022 Most common adverse reactions (\u2265 20%) of patients with resectable, Stage II/III NSCLC [neoadjuvant /adjuvant]) are anemia, nausea, constipation, fatigue, musculoskeletal pain, and rash. ( 6.1 ) IMFINZI as a Single Agent \u2022 Most common adverse reactions (\u2265 20%) of patients with unresectable, Stage III NSCLC) are cough, fatigue, pneumonitis/radiation pneumonitis, upper respiratory tract infections, dyspnea, and rash. ( 6.1 ) IMFINZI in Combination with Tremelimumab-actl and Platinum-Based Chemothe rapy \u2022 Most common adverse reactions (\u2265 20%) of patients with metastatic NSCLC) are nausea, fatigue, musculoskeletal pain, decreased appetite, rash, and diarrhea. ( 6.1 ) IMFINZI as a Single Agent \u2022 Most common adverse reactions (\u2265 20%) of patients with limited-stage SCLC) are pneumonitis or radiation pneumonitis, and fatigue. ( 6.1 ) IMFINZI in Combination with Platinum-Based Chemotherapy \u2022 Most common adverse ...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Indications and Usage ( 1.6 ) 05/2026 Indications and Usage ( 1.7 ) 11/2025 Dosage and Administration ( 2.2 ) 05/2026 Warnings and Precautions ( 5.1 ) 08/2026",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Medication Guide). Immune-Mediated Adverse Reactions Inform patients of the risk of immune-mediated adverse reactions that may require corticosteroid treatment and interruption or discontinuation of IMFINZI [see Warnings and Precautions (5.1) ] , including: \u2022 Pneumonitis: Advise patients to contact their healthcare provider immediately for any new or worsening cough, chest pain, or shortness of breath. \u2022 Hepatitis: Advise patients to contact their healthcare provider immediately for jaundice, severe nausea or vomiting, pain on the right side of abdomen, lethargy, or easy bruising or bleeding. \u2022 Colitis: Advise patients to contact their healthcare provider immediately for diarrhea, blood or mucus in stools, or severe abdominal pain. \u2022 Endocrinopathies: Advise patients to contact their healthcare provider immediately for signs or symptoms of hypothyroidism, hyperthyroidism, adrenal insufficiency, type 1 diabetes mellitus, or hypophysitis. \u2022 Nephritis: Advise patients to contact their healthcare provider immediately for signs or symptoms of nephritis. \u2022 Dermatological Reactions: Advise patients to contact their healthcare p...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Non-Small Cell Lung Cancer (NSCLC) Neoadjuvant and Adjuvant Treatment of Resectable NSCLC \u2013 AEGEAN Study The efficacy of IMFINZI in combination with neoadjuvant chemotherapy, followed by surgery and continued adjuvant treatment with IMFINZI as a single agent was investigated in AEGEAN (NCT03800134), a randomized, double-blind, placebo-controlled, multicenter trial conducted in 802 patients with previously untreated and resectable squamous or non-squamous NSCLC (Stage IIA to select Stage IIIB [AJCC, 8th edition]). Patients were enrolled regardless of tumor PD-L1 expression. Eligible patients had no prior exposure to immune-mediated therapy, a WHO/ECOG Performance status of 0 or 1, and at least one RECIST 1.1 target lesion. Patients with active or prior documented autoimmune disease, or use of any immunosuppressive medication within 14 days of the first dose of IMFINZI were ineligible. The population for efficacy analyses was a modified intent-to-treat [mITT] which excluded patients with known EGFR mutations or ALK rearrangements. Crossover between the study arms was not permitted. Randomization was stratified by disease stage (Stage II vs. Stage III) and by PD-L1 expression (TC...",
  "brand_name": "IMFINZI",
  "manufacturer": "AstraZeneca Pharmaceuticals LP",
  "application_number": "BLA761069",
  "pharm_class_epc": [
   "Programmed Death Ligand-1 Blocker [EPC]"
  ],
  "route": [
   "INTRAVENOUS"
  ],
  "effective_time": "20260831",
  "set_id": "8baba4ea-2855-42fa-9bd9-5a7548d4cec3",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 21609,
  "serious": 20662,
  "death": 6706,
  "hospitalization": 7148,
  "primary_suspect": 21593,
  "top_reactions": [
   [
    "Death",
    3872
   ],
   [
    "Malignant Neoplasm Progression",
    1610
   ],
   [
    "Pneumonitis",
    917
   ],
   [
    "Radiation Pneumonitis",
    809
   ],
   [
    "Pyrexia",
    697
   ],
   [
    "Diarrhoea",
    690
   ],
   [
    "Off Label Use",
    581
   ],
   [
    "Pneumonia",
    564
   ],
   [
    "Dyspnoea",
    522
   ],
   [
    "Interstitial Lung Disease",
    495
   ],
   [
    "Fatigue",
    474
   ],
   [
    "Anaemia",
    451
   ],
   [
    "Rash",
    442
   ],
   [
    "Asthenia",
    439
   ],
   [
    "Neutrophil Count Decreased",
    419
   ]
  ],
  "by_year": {
   "2019": 1506,
   "2020": 1505,
   "2021": 1739,
   "2022": 1512,
   "2023": 2836,
   "2024": 3709,
   "2025": 4000,
   "2026": 2689
  },
  "by_year_primary": {
   "2019": 1506,
   "2020": 1505,
   "2021": 1738,
   "2022": 1510,
   "2023": 2835,
   "2024": 3708,
   "2025": 3995,
   "2026": 2683
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 1,
  "nda": 0,
  "anda": 0,
  "first_approval": "20170501",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [
   "ASTRAZENECA UK LTD"
  ],
  "unapproved": false,
  "first_approval_fmt": "05/01/2017"
 },
 "trials": {
  "total": 919,
  "completed": 264,
  "terminated": 137,
  "with_results": 197,
  "industry": 538,
  "phase3": 107,
  "results_share": 0.7462121212121212,
  "terminated_share": 0.14907508161044614
 },
 "pubmed": {
  "rct": 138,
  "meta": 17,
  "recent_rct": 117,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 14548451.02,
  "records": 11984,
  "by_name": [
   [
    "Imfinzi",
    14548451.02
   ]
  ],
  "names_checked": [
   "durvalumab",
   "Imfinzi"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 2290,
  "beneficiaries": 463,
  "spend": 26299907.1,
  "by_brand": [
   {
    "brand": "Imfinzi",
    "claims": 2290,
    "per_claim": 11484.67559,
    "is_generic": false
   }
  ],
  "per_claim": 11484.675589519651
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "ApplicationRejected",
  "name": "durvalumab",
  "matched": "durvalumab",
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 88,
   "letter": "A",
   "why": [
    "Death appears in 3.4x the share of reports seen across all of FAERS (-12)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 61,
   "letter": "D",
   "why": [
    "138 randomized trials and 17 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 95,
   "letter": "A",
   "why": [
    "No recalls on record since 2016",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 55,
   "letter": "D",
   "why": [
    "Pharma paid doctors $14,548,451 tied to this drug last year (-45)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "9 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 76,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are death, malignant neoplasm progression, pneumonitis, radiation pneumonitis. How would we recognize and handle those?",
  "Why this one over atezolizumab, avelumab, cemiplimab? What would make you pick one of those instead?",
  "There is no generic. Is there an older generic in the same class that works as well for my situation?",
  "The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}