Follow the FDA Oncology Center of Excellence on Twitter at @FDAOncology, An official website of the United States government, : •Immune-Mediated Nephritis [see Warnings and Precautions (5.5)]. Discard unused portion.Store at 2° to 8°C (36° to 46°F).Do not freeze or shake.Keep vial in original carton to protect from light.Attention Pharmacist: Dispense the accompanying Medication Guide to each patient.Do not use if vial seal is broken or missing.Must dilute before use.See prescribing information.AstraZeneca. IMFINZI is supplied as a single-use vial and does not contain any preservatives, therefore, aseptic technique must be observed. Administration of durvalumab resulted in premature delivery, fetal loss (abortion and stillbirth) and increase in neonatal deaths. U.S. License Holder: AstraZeneca UK Ltd. •Immune-Mediated Pneumonitis [see Warnings and Precautions (5.1)]. Monitor patients for signs and symptoms of pneumonitis. Adverse Reactions Occurring in ≥ 10% Patients in the PACIFIC StudyIMFINZIN=475PlaceboThe PACIFIC study was not designed to demonstrate statistically significant difference in adverse reaction rates for IMFINZI, as compared to placebo, for any specific adverse reaction listed in Table 4N=234Adverse ReactionAll Grades(%)Grades 3-4(%)All Grades(%)Grades 3-4(%)Respiratory, Thoracic and Mediastinal DisordersCough/Productive Cough400.6300.4Pneumonitisincludes acute interstitial pneumonitis, interstitial lung disease, pneumonitis, pulmonary fibrosis/Radiation Pneumonitis343.4253.0Dyspneaincludes dyspnea and exertional dyspnea251.5252.6Gastrointestinal DisordersDiarrhea180.6191.3Abdominal painincludes abdominal pain, abdominal pain lower, abdominal pain upper, and flank pain100.460.4Endocrine DisordersHypothyroidismincludes autoimmune hypothyroidism and hypothyroidism120.21.70Skin and Subcutaneous Tissue DisordersRashincludes rash erythematous, rash generalized, rash macular, rash maculopapular, rash papular, rash pruritic, rash pustular, erythema, eczema, rash and dermatitis230.6120Pruritusincludes pruritus generalized and pruritus12060General Disorders Fatigueincludes asthenia and fatigue340.8321.3Pyrexia150.290InfectionsUpper respiratory tract infectionsincludes laryngitis, nasopharyngitis, peritonsillar abscess, pharyngitis, rhinitis, sinusitis, tonsillitis, tracheobronchitis, and upper respiratory tract infection260.4190Pneumoniaincludes lung infection, pneumocystis jirovecii pneumonia, pneumonia, pneumonia adenoviral, pneumonia bacterial, pneumonia cytomegaloviral, pneumonia haemophilus, pneumonia klebsiella, pneumonia necrotising, pneumonia pneumococcal, and pneumonia streptococcal177126Other adverse reactions occurring in less than 10% of patients treated with IMFINZI were dysphonia, dysuria, night sweats, peripheral edema, and increased susceptibility to infections.Table 5 summarizes the laboratory abnormalities that occurred in at least 20% of patients treated with IMFINZI.Table 5. The safety and effectiveness of IMFINZI have not been established in pediatric patients. •Other Immune-Mediated Adverse Reactions: Advise patients to contact their healthcare provider immediately for signs or symptoms of aseptic meningitis, thrombocytopenic purpura, myocarditis, hemolytic anemia, myositis, uveitis and keratitis [see Warnings and Precautions (5.7)]. Advise females of reproductive potential to use effective contraception during treatment with IMFINZI and for at least 3 months after the last dose of IMFINZI [see Use in Specific Populations (8.1, 8.3)]. IMFINZI can cause severe and fatal immune-mediated adverse reactions. •Infection: Advise patients to contact their healthcare provider immediately for infection [see Warnings and Precautions (5.8)]. The recommended dose of IMFINZI is 10 mg/kg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression, unacceptable toxicity, or a maximum of 12 months. Recommended Dosage Modifications for Adverse ReactionsAdverse ReactionSeverityNational Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03. Human immunoglobulin G1 (IgG1) is known to cross the placental barrier; therefore, durvalumab has the potential to be transmitted from the mother to the developing fetus. SmPC; Adverse Event Reporting; About stage III NSCLC MOA Efficacy PD-L1 TESTING SAFETY Posology Patient Profiles More Hide. Initiate hormone replacement therapy or medical management of hyperthyroidism as clinically indicated. Last Update: February-15-2021 . IMFINZI may be used when your NSCLC: •has not spread outside your chest •cannot be removed by surgery, and •has responded or stabilized with initial treatment with chemotherapy that contains platinum, given at the same time as radiation therapy.It is not known if IMFINZI is safe and effective in children.Before you receive IMFINZI, tell your healthcare provider about all of your medical conditions, including if you: •have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus •have had an organ transplant •have lung or breathing problems •have liver problems •are being treated for an infection •are pregnant or plan to become pregnant. vial. Do not shake. In mouse allogeneic pregnancy models, disruption of PD-L1 signaling was shown to result in an increase in fetal loss. The median time to onset was 2 months (range: 1 day to 14.2 months). IMFINZI can harm your unborn baby. Each mL contains durvalumab, 50 mg, L-histidine (2 mg), L-histidine hydrochloride monohydrate (2.7 mg), α,α-trehalose dihydrate (104 mg), Polysorbate 80 (0.2 mg), and Water for Injection, USP.Each 120 mg vial of IMFINZI contains 120 mg of durvalumab in 2.4 mL solution. The most frequent serious adverse reactions reported in at least 2% of patients were pneumonitis or radiation pneumonitis (7%) and pneumonia (6%). The generic name of Imfinzi is durvalumab. •Colitis: Advise patients to contact their healthcare provider immediately for diarrhea, blood or mucus in stools, or severe abdominal pain [see Warnings and Precautions (5.3)]. •IMFINZI is usually given every 2 weeks. •are breastfeeding or plan to breastfeed. While immune-mediated reactions usually manifest during treatment with IMFINZI, immune-mediated adverse reactions can also manifest after discontinuation of IMFINZI.For suspected Grade 2 immune-mediated adverse reactions, exclude other causes and initiate corticosteroids as clinically indicated. This will allow quick identification of new safety information. Interrupt or permanently discontinue IMFINZI, based on the severity of the reaction [see Dosage and Administration (2.3)]. Powles T, O'Donnell PH, Massard C, et al. JAMA Oncol. Confirmed objective response rate (ORR) as assessed by blinded independent central review per RECIST 1.1, was 17.0% (95% CI: 11.9, 23.3). 2043IMFINZI is a registered trademark of AstraZeneca group of companies.For more information, call 1-800-236-9933 or go to www.IMFINZI.com©AstraZeneca 2018This Medication Guide has been approved by the U.S. Food and Drug Administration. The study population characteristics were: median age of 64 years (range: 23 to 90), 45% age 65 years or older, 70% male, 69% White, 27% Asian, 75% former smoker, 16% current smoker, and 51% had WHO performance status of 1. Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?This is the date when the listing record will expire if not updated or certified by the product labeler. A total of 475 patients received IMFINZI 10 mg/kg intravenously every 2 weeks. Mix diluted solution by gentle inversion. It is used to treat urothelial cancer and lung cancer. PD-L1 and PD-1 knockout mice have also shown decreased survival following infection with lymphocytic choriomeningitis virus. Tumor assessments were performed at Weeks 6, 12 and 16, then every 8 weeks for the first year and every 12 weeks thereafter. Imfinzi with NDC 0310-4500 is a a human prescription drug product labeled by Astrazeneca Pharmaceuticals Lp. Adverse Reactions in ≥ 10% of Patients in Study 1108 Urothelial Carcinoma CohortIMFINZIN=182Adverse ReactionAll Grades(%)Grades 3 – 4(%)Gastrointestinal DisordersConstipation211Nausea162Abdominal painIncludes abdominal pain upper, abdominal pain lower and flank pain143Diarrhea/Colitis131General Disorders and AdministrationFatigueIncludes asthenia, lethargy, and malaise396Peripheral edemaIncludes edema, localized edema, edema peripheral, lymphedema, peripheral swelling, scrotal edema, and scrotal swelling152Pyrexia/Tumor associated fever141InfectionsUrinary tract infectionIncludes cystitis, candiduria and urosepsis154Metabolism and Nutrition DisordersDecreased appetite/Hypophagia191Musculoskeletal and Connective Tissue DisordersMusculoskeletal painIncludes back pain, musculoskeletal chest pain, musculoskeletal pain and discomfort, myalgia, and neck pain244Respiratory, Thoracic, and Mediastinal DisordersDyspnea/Exertional Dyspnea132Cough/Productive Cough100Skin and Subcutaneous Tissue DisordersRashIncludes dermatitis, dermatitis acneiform, dermatitis psoriasiform, psoriasis, rash maculo-papular, rash pruritic, rash papular, rash pustular, skin toxicity, eczema, erythema, erythema multiforme, rash erythematous, acne, and lichen planus111Table 3. IMFINZI can cause immune-mediated colitis, defined as requiring use of corticosteroids.Monitor patients for signs and symptoms of diarrhea or colitis. Non-Proprietary Name: Durvalumab What is the Non-Proprietary Name?The non-proprietary name is sometimes called the generic name. Systemic corticosteroids were required in 1.9% of patients, with 1% requiring high-dose corticosteroids and 0.1% requiring other immunosuppressants (e.g., infliximab, mycophenolate). Grade 3-4 Laboratory Abnormalities Worsened from Baseline Occurring in ≥ 1% Patients in Study 1108 Urothelial Carcinoma CohortLaboratory AbnormalityGrade 3 - 4%Hyponatremia12Lymphopenia11Anemia8Increased alkaline phosphatase4Hypermagnesemia4Hypercalcemia3Hyperglycemia3Increased AST2Increased ALT1Hyperbilirubinemia1Increased creatinine1Neutropenia1Hyperkalemia1Hypokalemia1Hypoalbuminemia1Non-Small Cell Lung CancerThe safety of IMFINZI in patients with Stage III NSCLC who completed concurrent platinum-based chemoradiotherapy within 42 days prior to initiation of study drug was evaluated in the PACIFIC study, a multicenter, randomized, double-blind, placebo-controlled study. Durvalumab was administered from the confirmation of pregnancy through delivery at exposure levels approximately 6 to 20 times higher than those observed at the recommended clinical dose of 10 mg/kg (based on AUC). Date of License: May-01-2017 . 5.6 Immune-Mediated Dermatologic Reactions. IMFINZI was discontinued in 0.3% of the 1889 patients. •Infusion-Related Reactions [see Warnings and Precautions (5.9)]. Durvalumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that is produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell suspension culture.IMFINZI (durvalumab) Injection for intravenous use is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow solution, free from visible particles.Each 500 mg vial of IMFINZI contains 500 mg of durvalumab in 10 mL solution. The development of treatment-emergent ADA against durvalumab appears to have no clinically relevant effect on its pharmacokinetic profile. You can ask your healthcare provider for information about IMFINZI that is written for health professionals.What are the ingredients in IMFINZI?Active ingredient: durvalumabInactive ingredients: L-histidine, L-histidine hydrochloride monohydrate, α,α-trehalose dihydrate, polysorbate 80, water for injection, USP.Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850By: AstraZeneca UK Limited1 Francis Crick Ave.Cambridge, England CB2 0AAUS License No. •Discard partially used or empty vials of IMFINZI.Storage of Infusion Solution •IMFINZI does not contain a preservative. Interrupt or permanently discontinue IMFINZI based on the severity [see Dosage and Administration (2.3)].In clinical studies enrolling 1889 patients with various cancers who received IMFINZI [see Adverse Reactions (6.1)], hepatitis occurred in 12% of patients, including Grade 3 (4.4%), Grade 4 (0.4%) and Grade 5 (0.2%) immune-mediated hepatitis. PD-L1 blocks T-cell function and activation through interaction with PD-1 and CD80 (B7.1). 13.2 Animal Toxicology And/Or Pharmacology. •Other Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.7)]. The study population characteristics were: median age of 64 years (range: 23 to 90); 70% male; 69% White and 27% Asian; 16% current smokers, 75% former smokers and 9% never smokers; 51% WHO performance status of 1; 53% with Stage IIIA and 45% were Stage IIIB; 46% with squamous and 54% with non-squamous histology. These problems can sometimes become serious or life-threatening and can lead to death.Call or see your healthcare provider right away if you develop any symptoms of the following problems or these symptoms get worse:Lung problems (pneumonitis). The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. Interrupt or permanently discontinue IMFINZI based on the severity [see Dosage and Administration (2.3)].In clinical studies enrolling 1889 patients with various cancers who received IMFINZI [see Adverse Reactions (6.1)], pneumonitis occurred in 5% of patients, including Grade 3 (0.8%), Grade 4 (< 0.1%) and Grade 5 (0.3%) immune-mediated pneumonitis. The generic name usually includes the active ingredient(s) of the product. The trial excluded patients with a history of immunodeficiency; medical conditions that required systemic immunosuppression (not to exceed 10 mg per day of prednisone or equivalent); history of severe autoimmune disease; untreated CNS metastases; HIV; active tuberculosis, or hepatitis B or C infection. IMFINZI can cause immune-mediated endocrinopathies, including thyroid disorders, adrenal insufficiency, type 1 diabetes mellitus and hypophysitis/hypopituitarism.Thyroid Disorders: Monitor thyroid function prior to and periodically during treatment with IMFINZI. Table 7. Table 4 summarizes the adverse reactions that occurred in at least 10% of patients treated with IMFINZI.Table 4. The efficacy of IMFINZI was evaluated in the urothelial carcinoma cohort of Study 1108 (NCT01693562), a multicenter, multi-cohort, open-label clinical trial. In the PACIFIC study the most common Grade 3 or higher infection was pneumonia, which occurred in 5% of patients. Durvalumab was detected in infant serum on postpartum Day 1, indicating the presence of placental transfer of durvalumab. The recommended dose of durvalumab is 10 mg/kg, administered as an intravenous infusionover 60 minutes every 2 weeks until disease progression or unacceptable toxicity. Durvalumab (Imfinzi®) product monograph. If infusion solution is not administered immediately and needs to be stored, the total time from vial puncture to the start of the administration should not exceed:o24 hours in a refrigerator at 2°C to 8°C (36°F to 46°F)o4 hours at room temperature up to 25°C (77°F) •Do not freeze. Imfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour's immune-evading tactics and releasing the inhibition of immune responses. Systemic corticosteroids were required in 21% of patients, with 12% requiring high-dose corticosteroids and 0.1% requiring infliximab. Efficacy Results for the PACIFIC Study Endpoint IMFINZI (N=476)Among the ITT population, 7% in the IMFINZI arm and 10% in the placebo arm had non-measurable disease as assessed by BICR according to RECIST v1.1 Placebo (N=237) Progression-Free Survival (PFS)Blinded Independent Central Review Number (%) of patients with event 214 (45%) 157 (66%) Median in months (95% CI) 16.8 (13, 18.1) 5.6 (4.6, 7.8) Hazard Ratio (95% CI)Stratified by sex, age, and smoking history Pike estimator 0.52 (0.42, 0.65) p-value (log-rank)Compared with allocated α of 0.0104 (Lan DeMets spending function approximating O’Brien Fleming boundary) for interim analysis. IMFINZI, , is indicated for the first -line Tell your doctor if you have any side effect that bothers you or that does not go away. Many of Over the Counter drugs are not reviewed by the FDA but they might be marketed to the public if the product complies with the applicable rules and regulations. AstraZeneca AZN announced that the FDA has approved the label expansion of its PD-1/PD-L1 immunotherapy, Imfinzi (durvalumab), as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC). 2.1 Recommended Dosage For Urothelial Carcinoma. Labeler Name: Astrazeneca Pharmaceuticals Lp Labeler Code: 0310 FDA Application Number: BLA761069 What is the FDA Application Number?This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. Site destinado a informações sobre a AstraZeneca do Brasil. Fatal pneumonitis or radiation pneumonitis and fatal pneumonia occurred in < 2% of patients and were similar across arms. Product Type: Human Prescription Drug What kind of product is this?Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. •Infusion-Related Reactions: Advise patients to contact their healthcare provider immediately for signs or symptoms of infusion-related reactions [see Warnings and Precautions (5.9)]. It is not known if IMFINZI passes into your breast milk. In the case of Imfinzi, the labeling change means loss of the indication that first enabled the drug to reach the US market in May 2017. The most frequent serious adverse reactions (> 2%) were acute kidney injury (4.9%), urinary tract infection (4.4%), musculoskeletal pain (4.4%), liver injury (3.3%), general physical health deterioration (3.3%), sepsis, abdominal pain and pyrexia/tumor associated fever (2.7% each).Table 2 summarizes the adverse reactions that occurred in ≥ 10% of patients, while Table 3 summarizes the Grade 3 - 4 laboratory abnormalities that occurred in ≥ 1% of patients treated with IMFINZI in the urothelial carcinoma cohort of Study 1108.Table 2. ALT: alanine aminotransferase; AST: aspartate aminotransferase; ULN: upper limit of normal.Dosage ModificationPneumonitis [see Warnings and Precautions (5.1)]Grade 2Withhold dose until Grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent).Grade 3 or 4Permanently discontinue Hepatitis [see Warnings and Precautions (5.2)]For ALT or AST greater than 3 but less than or equal to 8 times the ULNorTotal bilirubin greater than 1.5 but less than or equal to 5 times the ULNWithhold dose until Grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent).ALT or AST greater than 8 times the ULN or total bilirubin greater than 5 times the ULN orConcurrent ALT or AST greater than 3 times the ULN and total bilirubin greater than 2 times the ULN with no other causePermanently discontinueColitis or diarrhea [see Warnings and Precautions (5.3)]Grade 2Withhold dose until Grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent).Grade 3 or 4Permanently discontinueHyperthyroidism [see Warnings and Precautions (5.4)]Grade 2-4Withhold dose until clinically stableAdrenal insufficiency or Hypophysitis/Hypopituitarism [see Warnings and Precautions (5.4)]Grade 2-4 Withhold dose until clinically stableType 1 DiabetesMellitus [see Warnings and Precautions (5.4)]Grade 2-4 Withhold dose until clinically stableNephritis [see Warnings and Precautions (5.5)]For Creatinine greater than 1.5 to 3 times the ULNWithhold dose until Grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent).For Creatinine greater than 3 times the ULNPermanently discontinueRash or dermatitis [see Warnings and Precautions (5.6)]Grade 2 for longer than 1 week or Grade 3Withhold dose until Grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent).Grade 4Permanently discontinueInfection [see Warnings and Precautions (5.8)]Grade 3 or 4Withhold dose until clinically stableInfusion-related reactions [see Warnings and Precautions (5.9)]Grade 1 or 2 Interrupt or slow the rate of infusion Grade 3 or 4 Permanently discontinueOther immune-mediated adverse reactions [see Warnings and Precautions (5.7)]Grade 3Withhold dose until Grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent).Grade 4Permanently discontinuePersistent Grade 2 or 3 adverse reaction (excluding endocrinopathies)Grade 2 or 3 adverse reaction that does not recover to Grade 0 or 1 within 12 weeks after last IMFINZI dose Permanently discontinueInability to taper corticosteroidInability to reduce to less than or equal to prednisone 10 mg per day (or equivalent) within 12 weeks after the last IMFINZI dose Permanently discontinueRecurrent Grade 3 or 4 adverse reactionRecurrent Grade 3 or 4 (severe or life-threatening) adverse reactionPermanently discontinue. On May 1, 2017, the U.S. Food and Drug Administration granted accelerated approval to durvalumab (IMFINZI, AstraZeneca UK Limited) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Package Description: 1 VIAL in 1 CARTON > 2.4 mL in 1 VIAL. In Study 1108, 182 patients with locally advanced or metastatic urothelial carcinoma were enrolled. imfinzi® product monograph.copyright2017-2020, astrazeneca canada inc. page 3of 56 recent major label changes indications (1) 09-2020 dosage and administration (3) 05-2019 dosage and administration (3.1) 09-2020 warnings and precautions (7) 09-2020 warnings and precautions (7.1.4) 09 … Nephritis resolved in 50% of patients. Systemic corticosteroids were required in 2.0% of patients, including high-dose corticosteroids in 1% of patients. The most common adverse reactions leading to IMFINZI discontinuation were pneumonitis or radiation pneumonitis in 6% of patients. Continue IMFINZI for hypothyroidism and interrupt for hyperthyroidism based on the severity [see Dosage and Administration (2.3)]. For unapproved drugs, this field will be null. Advise the patient to read the FDA-approved patient labeling (Medication Guide).Inform patients of the risk of immune-mediated adverse reactions that may require corticosteroid treatment and interruption or discontinuation of IMFINZI, including: •Pneumonitis: Advise patients to contact their healthcare provider immediately for any new or worsening cough, chest pain, or shortness of breath [see Warnings and Precautions (5.1)]. Fatal cases have been reported. You may report side effects to FDA at 1-800-FDA-1088.General information about the safe and effective use of IMFINZI.Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Important Safety Information . •Infection [see Warnings and Precautions (5.8)]. In animal reproduction studies, administration of durvalumab to cynomolgus monkeys from the onset of organogenesis through delivery resulted in increased premature delivery, fetal loss and premature neonatal death. Values = ‘Y’ or ‘N’. The study excluded patients who had disease progression following chemoradiation, with active or prior autoimmune disease within 2 years of initiation of the study or with medical conditions that required systemic immunosuppression [see Clinical Studies (14.2)]. ContraceptionFemalesBased on its mechanism of action and data from animal studies, IMFINZI can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)]. Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Systemic corticosteroids were required in 2.7% of patients, with 1.7% requiring high-dose corticosteroids and 0.1% requiring mycophenolate. Patients received IMFINZI 10 mg/kg intravenously every 2 weeks [see Clinical Studies (14.1)]. All patients received definitive radiotherapy as per protocol, of which 92% received a total radiation dose of 54 Gy to 66 Gy. IMFINZI is only to be administered by intravenous infusion. It was a much narrower label than what they had initially sought, but the approval marked the best news the Boston biotech has put out in years. Advise pregnant women of the potential risk to a fetus. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.The data described in the Warnings and Precautions section reflect exposure to IMFINZI in 1889 patients from the PACIFIC study (a randomized, placebo-controlled study that enrolled 475 patients with Stage III NSCLC), Study 1108 (an open-label, single-arm, multicohort study that enrolled 191 patients with urothelial carcinoma and 779 patients with various other solid tumors), and an additional open-label, single-arm trial that enrolled 444 patients with metastatic lung cancer, an indication for which durvalumab is not approved. All patients received definitive radiotherapy as per protocol, of which 92% received a total radiation dose of 54 Gy to 66 Gy; 99% of patients received concomitant platinum-based chemotherapy (55% cisplatin-based, 42% carboplatin-based chemotherapy and 2% switched between cisplatin and carboplatin). The median time to onset of pneumonitis was 1.8 months and the median duration was 2.1 months (range: 3 days to 18.7 months). Based on its mechanism of action and data from animal studies, IMFINZI can cause fetal harm when administered to a pregnant woman. Imfinzi. 2.3. •Endocrinopathies: Advise patients to contact their healthcare provider immediately for signs or symptoms of hypothyroidism, hyperthyroidism, adrenal insufficiency, type 1 diabetes mellitus, or hypophysitis [see Warnings and Precautions (5.4)]. Systemic corticosteroids were required in 3.5% of the 1889 patients, with 2.5% requiring high-dose corticosteroids (prednisone ≥ 40 mg per day or equivalent) and 0.1% requiring infliximab. Durvalumab is a programmed cell death ligand 1 (PD-L1) blocking antibody. The Bellmunt risk score (which includes ECOG score, baseline hemoglobin, and liver metastases) was 0 in 23%, 1 in 38%, 2 in 29%, and 3 in 9% of patients. Before sharing sensitive information, make sure you're on a federal government site. Fatal cases have been reported.Monitor patients for signs and symptoms of hepatitis, during and after discontinuation of IMFINZI, including clinical chemistry monitoring. Approval was based on one single-arm trial of 182 patients with locally advanced or metastatic urothelial carcinoma whose disease progressed after prior platinum-containing chemotherapy. OS data were not mature at the time of the interim PFS analysis. Marketing Category: BLA - A product marketed under an approved Biologic License Application. FDA approved this application approximately 6 weeks ahead of the goal date. Sixty-six percent (66%) of patients had ECOG score of 1 and 41% of patients had a baseline creatinine clearance < 60 mL/min. Results are presented in Table 7 and Figure 1. These immune-mediated reactions may involve any organ system. •Your healthcare provider will test your blood to check you for certain side effects. Efficacy and Safety of Durvalumab in Locally Advanced or Metastatic Urothelial Carcinoma: Updated Results From a Phase 1/2 Open-label Study. The following adverse reactions are discussed in greater detail in other sections of the labeling. Expression of programmed cell death ligand-1 (PD-L1) can be induced by inflammatory signals (e.g., IFN-gamma) and can be expressed on both tumor cells and tumor-associated immune cells in the tumor microenvironment. Medical . Systemic corticosteroids were required in 0.6% of patients, with 0.4% receiving high-dose corticosteroids. Pneumonitis led to discontinuation of IMFINZI in 1.5% of the 1889 patients.
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