imfinzi package insert 2020

Imfinzi [package insert]. Phase II study of single-agent gemcitabine in previously untreated patients with metastatic urothelial cancer. National Comprehensive Cancer Network, Inc. February 2020. Updated November 10, 2020. Wilmington, DE; AstraZeneca Pharmaceuticals LP; August 2019. Durvalumab. 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 (New disease entity) Small cell lung cancer IMFINZI (durvalumab) POLICY . The clinical reviewer, Megan May, PharmD, BCOP has no actual or potential conflict of Important Safety Information . 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. 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. AHFS DI. 2. 4.2 Posology and method of administration Treatment must be initiated and supervised by … 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 Imfinzi PI prescribing information. 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. Durvalumab (Imfinzi) package insert; History of changes in FDA indication Non-small cell lung cancer. 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. 2020 No. 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. 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. NCCN Drugs & Biologics Compendium ® Durvalumab 2019. 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 … Package inserts. Imfinzi [package insert]. ATTACHMENTS None VII. Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Imfinzi is a medicine used to treat a type of lung cancer called non-small cell lung cancer (NSCLC). 2020;131:68-75. AstraZeneca Pharmaceuticals LP. INDICATIONS . 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. In unresectable Stage III NSCLC following chemoradiotherapy. 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 … 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. 2. 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 Page 6of 56 The recommended dose of IMFINZI depends on the indication. – 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) IMFINZI is administered as an intravenous infusion over 60 minutes. 2.0 Dose must be rounded down to the nearest vial size if calculated dose is within 10% of the nearest vial size. CALQUENCE may be … All PIs will be changed to the new format by the end of 2020. Final Approval – Utilization Management Committee VI. Retrieved January 7, 2020 from Lexi-Comp Online with AHFS. IMFINZI ® (durvalumab) demonstrated consistent results in median PFS in 1-year through 4-year analyses 1,2,5. 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. – 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) V. APPROVAL AUTHORITY 1. Review – Utilization Management Department 2. 3. Accessed March 16, 2020. 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 available in … References 1. 1. 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. 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). There are no contraindications for IMFINZI ® (durvalumab).. Immune-Mediated Adverse Reactions. Durvalumab (trade name Imfinzi) is an FDA-approved immunotherapy for cancer, developed by Medimmune/AstraZeneca. 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). Wilmington, DE: AstraZeneca Pharmaceuticals LP; August 2019. 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. Lexi-Comp Online. Sezer A, Kilickap S, Gümüş M, et al. 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: Durvalumab is a monoclonal antibody that acts as an 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. Imfinzi [package insert]. CRX-ALL-0540-20 Imfinzi (durvalumab) Override(s) Approval Duration Prior Authorization 1 year Medications Imfinzi ... 2. NCCN Clinical Practice Guidelines in Oncology ® Small Cell Lung Cancer (Version 3.2020). frequently than listed in the package insert, or generally accepted by peers and the reason for additional services is not justified by submitted documentation. Note that market specific restrictions or transition-of-care benefit limitations may apply. HOW WAS IMFINZI STUDIED? 3. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. 2021;397(10274):592-604. Imfinzi™ is a programmed death ligand-1 (PD-L1) blocking antibody administered intravenously as immunotherapy. Urothelial Carcinoma The recommended dose of IMFINZI (durvalumab) is 10 mg/kg every 2 weeks as long as clinical A. FDA-Approved Indication 1. 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 ©2020, Magellan Rx Management VI. Stadler WM, Kuzel T, Roth B, et al. IMFINZI (durvalumab) POLICY I. A. FDA-Approved Indication 1. CALQUENCE® (acalabrutinib) capsules, for oral use 2 Advise patients to swallow capsule whole with water. I. (2019, October). Wilmington, DE 2020. MICROMEDEX Healthcare Series. Lancet. 3. WHO Pharmaceuticals Newsletter No. 39. 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). Dr. Holle and Ms. Moran have disclosed that they have no actual or potential conflict of interest in relation to this program. REFERENCES 1. 1-year primary PFS analysis (14.5 months median follow-up): PFS was statistically significant 2,5 *. _____ INDICATIONS AND USAGE _____ o LIBTAYO is a programmed death receptor-1 (PD-1) blocking antibody indicated: Cutaneous Squamous Cell … DailyMed. Advise patients not to open, break or chew the capsules. Progression-Free Survival. Please refer to the FDA label/package insert for details regarding these topics. IMFINZI® Product Monograph.COPYRIGHT2017-2020, ASTRAZENECA CANADA INC. Accessed November 20, 2020.

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