Expert Opin Drug Saf. This study looked at the outcomes of durvalumab (Imfinzi) in patients with unresectable (cannot be surgically removed) stage 3 non-small cell lung cancer (NSCLC) who received different combinations of chemoradiotherapy (CRT) previously. 2016 May;17(3):232-236.e1. Bronchopleural fistula following a video-assisted thoracoscopic surgery lobectomy after neoadjuvant therapy of pembrolizumab: a case report and literature review. r A table of NHS England interim treatment regimens gives possible alternative treatment options for use during the COVID-19 pandemic to reduce infection risk. The evaluation was based on the comparison of patients randomized to durvalumab plus chemotherapy vs. chemotherapy alone. This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. On March 27, 2020, the Food and Drug Administration approved durvalumab (IMFINZI, AstraZeneca) in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC). A Phase III Study of Durvalumab (MEDI4736) With or Without Tremelimumab for Previously Treated Patients With Advanced NSCLC: Rationale and Protocol Design of the ARCTIC Study. FOIA Its brand name form, AstraZeneca’s Imfinzi®, was approved by the U.S. Food and Drug Administration (FDA) on May 1, 2017, for patients with previously-treated, advanced-stage bladder cancer. For non-small cell lung cancer, durvalumab has been studied in a phase III trial. Locally Advanced, Unresectable Non-Small Cell Lung Cancer: Durvalumab 10 mg/kg IV every 2 weeks for 12 months or until disease progression or unacceptable toxicity. The US Food and Drug Administration (FDA) has approved Imfinzi (durvalumab) for people with stage III (3) non-small cell lung cancer who are not able to be treated with surgery to remove their tumor, and whose cancer has not gotten worse after they received chemotherapy along with radiation (chemoradiation). These data formed the basis for subsequent approvals of durvalumab as a treatment for patients with unresectable, stage III non-small-cell lung cancer whose disease had not progressed following platinum-based chemoradiotherapy. 2018 Feb;14(3):205-222. doi: 10.2217/fon-2017-0373. You might have it as a treatment for non small cell lung cancer (NSCLC). National Library of Medicine The recommended durvalumab dose when administered with etoposide and either carboplatin or cisplatin is 1500 mg every 3 weeks prior to chemotherapy and then every 4 weeks as a single agent. For information on the COVID-19 pandemic, see the following resources: Follow the Oncology Center of Excellence on Twitter @FDAOncology. 2020 Nov 6;8(21):5172-5179. doi: 10.12998/wjcc.v8.i21.5172. Before sharing sensitive information, make sure you're on a federal government site. The PACIFIC study assessed the effectiveness of durvalumab as maintenance therapy following definitive chemoradiotherapy for unresectable stage III NSCLC, and met its primary endpoints of progression-free survival and overall survival. Cao M, Fu Y, Xiao X, Tang J, Tang D, Zhao X. Ann Transl Med. Early results of a phase I trial combining durvalumab and gefitinibin lung cancer patients "showed promise". The goal of treatment with this drug is to keep the cancer from getting … Specifically, durvalumab is intended for patients with stage 3 lung cancer that cannot be removed surgically and has not … Epub 2017 Jul 13. Epub 2020 May 13. 2020 May 30;10(6):359. doi: 10.3390/diagnostics10060359. Ninatti G, Kirienko M, Neri E, Sollini M, Chiti A. Diagnostics (Basel). 2019 Nov 23;394(10212):1929-1939. doi: 10.1016/S0140-6736(19)32222-6. The authors found that the use of durvalumab improved survival in all patients previously treated with CRT. Immune checkpoint inhibitors, such as programmed cell death protein 1 and programmed death-ligand 1 (PD-L1) inhibitors, have opened a new era in the management of NSCLC. The .gov means it’s official.Federal government websites often end in .gov or .mil. Durvalumab plus platinum-etoposide versus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial Lancet . Gullapalli S, Remon J, Hendriks LEL, Lopes G. Onco Targets Ther. Use in Cancer. The U.S. Food and Drug Administration (FDA) recently approved expanding the use of the immunotherapeutic durvalumab (Imfinzi) to include the treatment of certain patients with the most common form of lung cancer – non-small cell lung cancer (NSCLC).. AstraZeneca has presented three-year overall survival (OS) results from the Phase III PACIFIC trial of Imfinzi (durvalumab) in unresectable, Stage III non-small cell lung cancer (NSCLC) during the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. Durvalumab is the first immunotherapy to be approved as adjuvant treatment for such patients whose cancer has not progressed after definitive chemoradiotherapy, Dr. Chung Yin Kong of Massachusetts General Hospital, in Boston, and colleagues note in JAMA Oncology, online December 13. The evidence supporting this protocol is provided by a phase 3, multicentre, international, randomised trial (PACIFIC) involving 709 patients comparing the anti-PDL1 antibody durvalumab with placebo as consolidation therapy in patients with stage III, locally advanced, unresectable non small cell lung cancer without disease progression after two or more cycles of platinum based definitive chemoradiotherapy. NCI CPTC Antibody Characterization Program. The major efficacy outcome measure was overall survival (OS). Durvalumab is approved to treat: Non-small cell lung cancer (NSCLC). Durvalumab is an immunotherapy medication used to treat cancer, specifically cancers of the lung and bladder. Please enable it to take advantage of the complete set of features! Phase 1 data in advanced metastatic urothelial bladder (Study 1108) has led to FDA breakthrough therapy designation. Durvalumab may also be used for purposes not listed in this medication guide. Keywords: You might also have durvalumab as part of a clinical trial for another type of cancer. Of the 54 patients included in the primary analysis, 65%, 78%, and 50% completed 6 cycles of platinum-based chemotherapy, 6 cycles of pemetrexed, and at least 12 cycles of durvalumab… It is used in adults with stage III NSCLC that cannot be removed by surgery and did not get worse after platinum chemotherapy and radiation therapy. FDA approves durvalumab for extensive-stage small cell lung cancer On March 27, 2020, the Food and Drug Administration approved durvalumab (IMFINZI, AstraZeneca) in … The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Lancet Oncol. Epub 2017 Nov 15. Durvalumab is sometimes given when the cancer has spread to other parts of the body or cannot be removed with surgery, or when other treatments did not work or have stopped working. A phase IB clinical trial of durvalumab and tremelimumab showed some activity in non-small cell lung cancer (NSCLC). Durvalumab is a type of immunotherapy. Listing a study does not mean it … The most common side effects when used with other anticancer medicines with SCLC include nausea, hair loss, and feeling tired or weak. For ES-SCLC, durvalumab is to be administered prior to chemotherapy on the same day. Careers. Durvalumab; NSCLC; PD-1; PD-L1; immune checkpoint inhibitors. IMFINZI ® (durvalumab) is a prescription medicine used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC). Introduction: The prognosis of patients with advanced non-small cell lung cancer (NSCLC) remains poor, with a 5-year overall survival rate of around 15%. For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov. It is an immunotherapy treatment (also called anticancer drug) that works with your immune system to detect and destroy cancer cells. The PD-L1 inhibitor durvalumab has been approved to treat patients with stage III NSCLC and, in combination with platinum-etoposide, to treat patients with extensive-stage small cell lung cancer (ES-SCLC). Prevention and treatment information (HHS). Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088. Front-Line Durvalumab for Extensive-Stage Small-Cell Lung Cancer. These results led to FDA approval for this NSCLC population. It is important to understand that durvalumab is not a traditional chemotherapy drug and has a different way of working. 2020 Jul 14;13:6885-6896. doi: 10.2147/OTT.S259308. 2020 Jun;19(6):653-659. doi: 10.1080/14740338.2020.1764936. Under the approval, durvalumab can be used as an initial treatment for people with extensive-stage SCLC. Durvalumab plus platinum–etoposide versus platinum–etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, … It will be exciting to follow ongoing phase III studies assessing how durvalumab fits into the rapidly evolving therapeutic landscape for advanced NSCLC. 2016 Mar;17(3):299-308. doi: 10.1016/S1470-2045(15)00544-6. The site is secure. Epub 2016 Feb 6. Unable to load your collection due to an error, Unable to load your delegates due to an error. Update on Targeted Therapies for Advanced Non-Small Cell Lung Cancer: Durvalumab in Context. Small cell lung cancer in adults. This may affect decisions on using durvalumab. Durvalumab in non-small-cell lung cancer patients: current developments. Three checkpoint inhibitors (nivolumab, pembrolizumab, and atezolizumab) are currently approved by the US Food and Drug Administration (FDA) for advanced NSCLC. Areas covered: In advanced NSCLC patients, durvalumab has demonstrated activity and acceptable tolerability, particularly with ≥25% PD-L1 tumor expression in the EGFR and ALK wild-type population. Expert Opin Biol Ther. A phase I clinical trial is currently underway using durvalumab with a TLR 7/8 agonist (MEDI 9197) for solid tumors. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Infusions of durvalumab were given to 473 patients and 236 were given a placebo. UPDATE: On March 27, 2020, the Food and Drug Administration (FDA) approved durvalumab (Imfinzi) to treat small cell lung cancer (SCLC). An official website of the United States government, : doi: 10.1016/j.cllc.2016.03.003. Epub 2016 Mar 17. Additional efficacy outcome measures were investigator-assessed progression-free survival (PFS) and objective response rate (ORR), per RECIST v1.1. Imaging-Based Prediction of Molecular Therapy Targets in NSCLC by Radiogenomics and AI Approaches: A Systematic Review. On Friday, February 16, 2018, the FDA approved durvalumab (IMFINZI ®, AstraZeneca), an anti-PD-L1 checkpoint immunotherapy, for patients with unresectable, stage III non-small cell lung cancer (NSCLC) that hasn’t progressed after prior chemo-radiation treatment. Median OS was 13.0 months (95% CI: 11.5, 14.8) in the durvalumab plus chemotherapy arm compared with 10.3 months (95% CI: 9.3, 11.2) in the chemotherapy alone arm (hazard ratio 0.73; 95% CI: 0.59, 0.91; p=0.0047). 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 treat cancer). Clipboard, Search History, and several other advanced features are temporarily unavailable. Future Oncol. Durvalumab Followed by Chemoradiation and Consolidation Durvalumab for Stage III Non-small Cell Lung Cancer. The investigator-assessed confirmed ORR was 68% (95% CI: 62%, 73%) in the durvalumab plus chemotherapy arm and 58% (95% CI: 52%, 63%) in the chemotherapy alone arm. MEDI 4736 (durvalumab) in non-small cell lung cancer. Clin Lung Cancer. Durvalumab, an anti-PD-L1 antibody, is under investigation in several trials.Areas covered: This article reviews the pharmacological properties, clinical efficacy, and safety of durvalumab as monotherapy and in combination with other drugs for the treatment of locally advanced and advanced NSCLC.Expert opinion: Durvalumab as monotherapy or in combination with tremelimumab was effective with well-tolerated safety profiles for advanced NSCLC in several phase I or II studies. 2020 Dec;8(24):1691. doi: 10.21037/atm-20-7582. 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. The patients had unresectable, locally advanced cancer (Stage III) and had been treated with chemotherapy and radiation. It is also known by its brand name, Imfinzi. COVID-19 is an emerging, rapidly evolving situation. Bethesda, MD 20894, Copyright Investigator-assessed PFS (96% of total planned events) showed a HR of 0.78 (95% CI: 0.65, 0.94), with median PFS of 5.1 months (95% CI: 4.7, 6.2) in the durvalumab plus chemotherapy arm and 5.4 months (95% CI: 4.8, 6.2) in the chemotherapy alone arm. Position of a panel of international lung cancer experts on the approval decision for use of durvalumab in stage III non-small-cell lung cancer (NSCLC) by the Committee for Medicinal Products for Human Use (CHMP) Ann Oncol, 30 (2) (2019), pp. Safety and antitumour activity of durvalumab plus tremelimumab in non-small cell lung cancer: a multicentre, phase 1b study. Durvalumab 10 mg/kg IV every 2 weeks until disease progression or unacceptable toxicity. Durvalumab also had a manageable safety profile, which was consistent with that of other immunotherapies. Safety evaluation of durvalumab for the treatment of non-small-cell lung cancer. Durvalumab (MEDI4736) is a high-affinity human IgG1 monoclonal antibody that binds to PD-1 and CD80, blocking PD-L1, but not PD-L2. This site needs JavaScript to work properly. Durvalumab for the treatment of non-small cell lung cancer. Efficacy of this combination in patients with previously untreated ES-SCLC was investigated in CASPIAN, a randomized, multicenter, active-controlled, open-label, trial (NCT03043872). Imfinzi contains the active substance durvalumab. FDA granted this application priority review and granted durvalumab orphan drug designation for this indication. Imfinzi is used specifically when the tumour produces a protein known as PD-L1. Importantly, this approval covers patients regardless of their PD-L1 expression status. Planchard D, Yokoi T, McCleod MJ, Fischer JR, Kim YC, Ballas M, Shi K, Soria JC. 8600 Rockville Pike Resources for Information | Approved Drugs, Recalls, Market Withdrawals and Safety Alerts, Resources for Information | Approved Drugs, Drug Information Soundcast in Clinical Oncology (D.I.S.C.O. Would you like email updates of new search results? 2017 Oct;17(10):1317-1323. doi: 10.1080/14712598.2017.1351939. ), Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description, FDA approves durvalumab for extensive-stage small cell lung cancer, View full prescribing information for IMFINZI, Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics, NCI: Coronavirus: What People With Cancer Should Know. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics. The CISPIAN trial was a randomized, open-label, multi-center, global, Phase III trial in the 1st-line treatment of patients with extensive-stage small-cell lung cancer (SCLC) and compared durvalumab in combination with etoposide and either cisplatin or carboplatin chemotherapy, or durvalumab,tremelimumab, and chemotherapy versus chemotherapy alone. Evidence-based recommendations on durvalumab (Imfinzi) for treating locally advanced unresectable non-small-cell lung cancer after platinum-based chemoradiation in adults. View full prescribing information for IMFINZI. 161-165. The most common adverse reactions (≥20%) in patients with ES-SCLC were nausea, fatigue/asthenia, and alopecia. Privacy, Help World J Clin Cases. A Phase 1b/2a trial is underway combining durval… Accessibility 1.1 Durvalumab monotherapy is recommended for use within the Cancer Drugs Fund as an option for treating locally advanced unresectable non-small-cell lung cancer (NSCLC) in adults whose tumours express PD‑L1 on at least 1% of tumour cells and whose disease has not progressed after platinum-based chemoradiation only if: The most common side effects in people with non-small cell lung cancer (NSCLC) include cough, feeling tired, inflammation in the lungs, upper respiratory tract infections, shortness of breath, and rash. Antonia S, Goldberg SB, Balmanoukian A, Chaft JE, Sanborn RE, Gupta A, Narwal R, Steele K, Gu Y, Karakunnel JJ, Rizvi NA. eCollection 2020. Efficacy and safety of S-1 maintenance therapy in advanced non-small-cell lung cancer patients. Durvalumab is used to treat cancer of the lungs, bladder, or urinary tract.