A Product Information document (PI) provides health professionals with a summary of the scientific information relevant to the safe and effective use of a prescription medicine, some non-prescription medicines and some biologicals. _____ INDICATIONS AND USAGE _____ o LIBTAYO is a programmed death receptor-1 (PD-1) blocking antibody indicated: Cutaneous Squamous Cell … AstraZeneca Pharmaceuticals LP. 1. The clinical reviewer, Megan May, PharmD, BCOP has no actual or potential conflict of All PIs will be changed to the new format by the end of 2020. (2019, October). HOW WAS IMFINZI STUDIED? 4.2 Posology and method of administration Treatment must be initiated and supervised by … 2.0 Dose must be rounded down to the nearest vial size if calculated dose is within 10% of the nearest vial size. 2020;131:68-75. NCCN Clinical Practice Guidelines in Oncology ® Small Cell Lung Cancer (Version 3.2020). Sezer A, Kilickap S, Gümüş M, et al. Dosage and Administration (2.3) 11/2020 Warnings and Precautions (5.1, 5.3) 11/2020 Warnings and Precautions (5.2) 02/2021 transplant rejection. Package Factor: 71288- 117-06: 200 mg per 5.26 mL, sterile solution in a single-dose glass vial: 1 vial per carton: 71288- 117-28: 1 gram per 26.3 mL, sterile solution in a single-dose glass vial: 1 vial per carton: 71288- 117-54: 2 grams per 52.6 mL, sterile solution in … Imfinzi [package insert]. 1-year primary PFS analysis (14.5 months median follow-up): PFS was statistically significant 2,5 *. Durvalumab. Revised: 11/2020 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 1.1 Melanoma 1.2 Non-Small Cell Lung Cancer 1.3 Small Cell Lung Cancer 1.4 Head and Neck Squamous Cell Cancer 1.5 Classical Hodgkin Lymphoma AstraZeneca has filed for a US licence for its Imfinzi immunotherapy in early-stage lung cancer, while announcing promising results from a lung cancer combination involving a Chinese-developed drug. The VENTANA PD-L1 (SP263) assay is an FDA-approved complementary diagnostic IHC test PD-L1 status in patients with locally advanced or metastatic urothelial carcinoma (mUC) who are being considered for treatment with IMFINZI™ (durvalumab). Accessed November 20, 2020. Durvalumab is a monoclonal antibody that acts as an frequently than listed in the package insert, or generally accepted by peers and the reason for additional services is not justified by submitted documentation. Boxed Warning, Removed 6/2020 Indications and Usage (1) 10/2020 Dosage and Administration (2) 11/2020 Warnings and Precautions (5) 11/2020-----INDICATIONS AND USAGE -----YERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for: Melanoma – Tecentriq and Imfinzi were approved in refractory urothelial cancer with response rates of 15% and 17%, respectively – Recent FDA approval for tazemetostat for epithelioid sarcoma with response rate of 11-15% Keytruda package insert 2019; Tecentriq package insert 2019; Imfinzi package insert 2019 Gastric (Keytruda) Urothelial (Tecentriq) Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. IMFINZI in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adultswith extensive-stage small cell lung cancer (ES-SCLC). A. FDA-Approved Indication 1. Important Safety Information . 2020 No. ©2020, Magellan Rx Management VI. ATTACHMENTS None VII. It is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that blocks the interaction of programmed cell death ligand 1 (PD-L1) with the PD-1 (CD279). Imfinzi is a medicine used to treat a type of lung cancer called non-small cell lung cancer (NSCLC). Page 6of 56 The recommended dose of IMFINZI depends on the indication. Revised:06/2020 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 1.1 Gastric Cancer 1.2 Non-Small Cell Lung Cancer 1.3 Colorectal Cancer 1.4 Hepatocellular Carcinoma 2 DOSAGE AND ADMINISTRATION 2.1 Premedication 2.2 Recommended Dosage for Gastric Cancer 2.3 Recommended Dosage for Non-Small Cell Lung Cancer Accessed March 16, 2020. Package inserts. IMFINZI® Product Monograph.COPYRIGHT2017-2020, ASTRAZENECA CANADA INC. 3. WHO Pharmaceuticals Newsletter No. In unresectable Stage III NSCLC following chemoradiotherapy. There are no contraindications for IMFINZI ® (durvalumab).. Immune-Mediated Adverse Reactions. Retrieved January 7, 2020 from Lexi-Comp Online with AHFS. 2/16/2018: FDA approved for patients with unresectable stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. NCCN Drugs & Biologics Compendium ® Durvalumab 2019. IMFINZI (durvalumab) POLICY . Billing Code/Availability Information HCPCS Code: • J9173 – Injection, durvalumab, 10 mg; 1 billable unit = 10 mg NDC: • Imfinzi 120 mg/2.4 mL single-dose vial: 00310-4500-xx • Imfinzi 500 mg/10 mL single-dose vial: 00310-4611-xx VII. Stadler WM, Kuzel T, Roth B, et al. Imfinzi PI prescribing information. MICROMEDEX Healthcare Series. CRX-ALL-0540-20 Imfinzi (durvalumab) Override(s) Approval Duration Prior Authorization 1 year Medications Imfinzi ... 2. Note that market specific restrictions or transition-of-care benefit limitations may apply. VENTANA PD-L1 (SP263) Assay is intended for the qualitative detection of the programmed death ligand 1 (PD-L1) protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC), urothelial carcinoma (UC) and other tumor tissues stained with OptiView DAB IHC Detection Kit on a BenchMark IHC/ISH instrument. Updated November 10, 2020. Imfinzi [package insert]. Wilmington, DE; AstraZeneca Pharmaceuticals LP; August 2019. For certain types and stages of cancer, testing for PD-L1 expression may help to identify patients most likely to benefit from treatment with PD-L1 … Imfinzi is used in adult patients with advanced cancer that cannot be removed by surgery but is not getting worse after treatment with radiation and platinum-based chemotherapy (medicines to … Please refer to the FDA label/package insert for details regarding these topics. DailyMed. 5/2020 12/2020 Indications and Usage, Hepatocellular Carcinoma (1.5) 5/2020 Indications and Usage, Melanoma (1.6) 7/2020 Dosage and Administration (2.3) Warnings and Precautions (5.1, 5.2, 5.3, 5.5) Warnings and Precautions (5.4) Dosage and Administration (2.2) 11/2020 11/2020 12/2020 02/2021 Final Approval – Utilization Management Committee VI. 3, 2020 ... package insert for baloxavir marboxil (Xofluza®) should be revised to include ischaemic ... (Imfinzi®) have been updated to reflect the risk of myasthenia gravis. Imfinzi™ is a programmed death ligand-1 (PD-L1) blocking antibody administered intravenously as immunotherapy. CALQUENCE® (acalabrutinib) capsules, for oral use 2 Advise patients to swallow capsule whole with water. CALQUENCE may be … Imfinzi [package insert]. Dosing and Administration Imfinzi Package Insert Guideline Imfinzi is considered medically necessary for members ≥ 18 years of age, for use as a single agent, when prescribed by an oncologist for the following indications: Phase II study of single-agent gemcitabine in previously untreated patients with metastatic urothelial cancer. INDICATIONS . REFERENCES 1. Durvalumab (trade name Imfinzi) is an FDA-approved immunotherapy for cancer, developed by Medimmune/AstraZeneca. IMFINZI is administered as an intravenous infusion over 60 minutes. Urothelial Carcinoma The recommended dose of IMFINZI (durvalumab) is 10 mg/kg every 2 weeks as long as clinical Programmed death-ligand 1 (PD-L1) is an immune-related biomarker that can be expressed on the surface of many tissue types, including tumor cells. INDICATIONS The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy. Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Dr. Holle and Ms. Moran have disclosed that they have no actual or potential conflict of interest in relation to this program. (New disease entity) Small cell lung cancer V. APPROVAL AUTHORITY 1. Review – Utilization Management Department 2. Advise patients not to open, break or chew the capsules. 3. Lancet. Cemiplimab monotherapy for first-line treatment of advanced non-small-cell lung cancer with PD-L1 of at least 50%: a multicentre, open-label, global, phase 3, randomised, controlled trial. Lexi-Comp Online. References 1. Wilmington, DE: AstraZeneca Pharmaceuticals LP; August 2019. 2021;397(10274):592-604. Imfinzi is available in … I. Durvalumab (Imfinzi) package insert; History of changes in FDA indication Non-small cell lung cancer. 3. 39. 2. A. FDA-Approved Indication 1. National Comprehensive Cancer Network, Inc. February 2020. Progression-Free Survival. Wilmington, DE 2020. 2. A clinical trial called the PACIFIC study compared 2 groups of patients with unresectable Stage 3 NSCLC who completed at least 2 cycles of platinum-based chemotherapy given at the same time (concurrently) as radiation.. Group 1: 476 patients received IMFINZI after CRT for up to 12 months or until disease progression or serious side effects occurred. IMFINZI ® (durvalumab) demonstrated consistent results in median PFS in 1-year through 4-year analyses 1,2,5. AHFS DI. The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy. IMFINZI (durvalumab) POLICY I. – Tecentriq and Imfinzi were approved in refractory urothelial cancer with response rates of 15% and 17%, respectively – Recent positive ODAC for tazemetostat for epithelioid sarcoma with response rate of 11-15% Keytruda package insert 2019; Tecentriq package insert 2019; Imfinzi package insert 2019 Gastric (Keytruda) Urothelial (Tecentriq)
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