Emma Morriss. Immuno-oncology (IO) is a therapeutic approach designed to stimulate the body’s immune system to attack tumours. The kinase inhibitor is seeking approval in a tiny population: as a whole the cancer amounts to only 3,000 or so new cases a year worldwide, and FGFR2 drives 10-15% of these. All work related to the COVID-19 pandemic will continue during this... EMA’s human medicines committee (CHMP) has adopted several important recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the EU. CASPIAN was a randomised, open-label, multi-centre, global, Phase III trial in the 1st-line treatment of 805 patients with ES-SCLC. The Company is pursuing a comprehensive clinical-trial programme that includes Imfinzi as a monotherapy and in combination with tremelimumab in multiple tumour types, stages of disease, and lines of therapy, and where relevant using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient. Conditional marketing authorisation - Report on ten years of experience at EMA 2. We encourage you to read the privacy policy of every website you visit. In addition to AstraZeneca's main capabilities, the Company is actively pursuing innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by the investment in Acerta Pharma in haematology. PIII trial CASPIAN found risk of death was reduced by 27% (equal to a hazard ratio of 0.73; p=0.0047), with median overall (OS) of 13.0 months for Imfinzi plus chemotherapy vs. 10.3 months for standard of care 7. Lung cancer is the leading cause of cancer death among both men and women and accounts for about one fifth of all cancer deaths.4 Lung cancer is broadly split into non-small cell lung cancer (NSCLC) and SCLC, with about 15% classified as SCLC.5 About two thirds of SCLC patients are diagnosed with ES-SCLC, in which the cancer has spread widely through the lung or to other parts of the body.6 Prognosis is particularly poor, as only 6% of all SCLC patients will be alive five years after diagnosis.6. Design Retrospective cohort study. National Cancer Institute. The primary endpoint was OS in each of the two experimental arms. Conditional approval This medicine received a conditional marketing authorisation. International Agency for Research on Cancer. AstraZeneca PLC. Shots: The P-III CASPIAN study involves assessing of Imfinzi + etoposide with cisplatin/carboplatin CT or Imfinzi + tremelimumab +CT vs CT as monothx. For the United Kingdom, as of 1 January 2021, European Union law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland / NI. The safety and tolerability for Imfinzi plus SoC was consistent with the known safety profiles of these medicines. AstraZeneca has a comprehensive portfolio of approved and potential new medicines in late-stage development for the treatment of different forms of lung cancer spanning different histologies, several stages of disease, lines of therapy and modes of action. EMA/511841/2020 Page 2/5 a consequence, sections 4.1, 4.2, 4.4, 4.5, 4.8, 5.1 and 5.2 of the SmPC were updated. Imfinzi’s marketing application is centred on the results of the CASPIAN trial, which showed that adding the PD-L1 inhibitor to standard chemotherapy with etoposide and either cisplatin or carboplatin reduced the risk of death by 27 Imfinzi approved in the US for extensive-stage small cell lung cancer, https://www.cancer.gov/publications/dictionaries/cancer-terms/def/small-cell-lung-cancer, http://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf, https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer, https://www.cancer.net/cancer-types/33776/view-all. The FDA has granted a priority review designation to a supplemental Biologics License Application (sBLA) for durvalumab (Imfinzi) for the frontline treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).1. Find answers to the most frequently asked questions we receive. 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. AstraZeneca’s Imfinzi (durvalumab) has been approved in the US as a 1st-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC) in combination with standard-of-care (SoC) chemotherapies, etoposide plus either carboplatin or cisplatin (platinum-etoposide). Imfinzi received its first approval based on the Phase III CASPIAN trial in Singapore for patients with ES-SCLC in February 2020. Keytruda already has approval for third-line SCLC treatment after the failure of chemotherapy and has a phase 3 trial as a first-line treatment nearing completion. First published: 04/11/2020 EMA/423776 List item CHMP post-authorisation summary of positive opinion for Crysvita (II-10-G) (PDF/131.81 KB) 8. 4. The CASPIAN trial met the primary endpoint of OS for Imfinzi plus chemotherapy in June 2019, reducing the risk of death by 27% versus chemotherapy alone. Intravenous durvalumab received US FDA accelerated approval in May 2017 for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing You have selected a link that will take you to a site maintained by a third party who is solely responsible for its contents. Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved and granted marketing authorisation for Tecentriq ® (atezolizumab) in combination with chemotherapy (carboplatin and etoposide) for the initial (first-line) treatment of adults with extensive-stage small cell lung cancer (ES-SCLC). In the EU, ivermectin tablets... CVMP opinions on veterinary medicinal products The Committee adopted by consensus a positive opinion for a type II variation application for Cortavance ( hydrocortisone aceponate ) to add “for alleviation of clinical signs associated with atopic... European Medicines AgencyDomenico Scarlattilaan 61083 HS AmsterdamThe Netherlands, Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines. consisting of up to six cycles of CT and optional prophylactic cranial irradiation (PCI) in patients with extensive-stage SCLC in 22+ countries The P-III CASPIAN study results: median OS (13.0 vs 10.3 […] With six new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca. AstraZeneca has announced that the EU has approved Imfinzi (durvalumab) for the 1st-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) in combination with a choice of chemotherapies, etoposide plus … The approval was based on positive results from the Phase III CASPIAN trial of Imfinzi plus chemotherapy in ES-SCLC. I have read this warning and will not be using any of the contained product information for clinical purposes. Veeva ID: Z4-25396Date of next review: August 2022. Lurbinectedin was active as second-line therapy for SCLC in terms of overall response and had an acceptable and manageable safety profile. In addition, the ability to combine the IO portfolio with radiation, chemotherapy, small targeted molecules from across AstraZeneca’s Oncology pipeline, and from research partners, may provide new treatment options across a broad range of tumours. An independent data and safety monitoring committee reviewed safety data regularly. EMA has published a 10-year report on its experience with conditional marketing authorisations, with data collected between July 2006 and June 2016: 1. 10-year report highlights During this period, 30 medicines received a conditional marketing authorisation. Tremelimumab blocks the activity of CTLA-4, contributing to T-cell activation, priming the immune response to cancer and fostering cancer cell death. The Russian jab is currently being assessed by Europe’s drug regulator, European Medicines Agency (EMA), which will decide whether the vaccine complies with efficacy, safety, and quality standards. Search for information on human, veterinary or herbal medicines. Protocol approval was obtained from an independent ethics committee at each site. Available at https://www.cancer.gov/publications/dictionaries/cancer-terms/def/small-cell-lung-cancer. Objective To characterize the therapeutic value of new drugs approved by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) and the association between these ratings and regulatory approval through expedited programs. Upcoming first-time US approval decisions with priority review (to June) NCI Dictionary - Small Cell Lung Cancer. Please refer to your approved national product label (SmPC) for current product information. Annex 2 - Detailed information on unsuccessful conditional marketing authorisations 4. New manufacturing site for AstraZeneca’s COVID-19 vaccine A new manufacturing... Five new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended five medicines for approval at its March 2021 meeting. Dave Fredrickson, Executive Vice President, Head of the Oncology Business, said: “Patients in Europe diagnosed with locally-advanced, unresectable non-small cell lung cancer now have a new treatment option. Setting New drugs approved by the FDA and EMA between 2007 and 2017, with follow-up through 1 April … None had to be revoke… 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. AstraZeneca’s approach to Immuno-Oncology (IO). 2. On March 18, 2019, the Food and Drug Administration approved atezolizumab (TECENTRIQ, Genentech Inc.) in combination with carboplatin and etoposide, for the first-line treatment of … For Media contacts, click here. 1. 2013:66;79-89. The trial compared Imfinzi in combination with etoposide and either carboplatin or cisplatin chemotherapy, or Imfinzi and chemotherapy with the addition of a second immunotherapy, tremelimumab, versus chemotherapy alone. Important notice for users Imfinzi is approved for the 1st-line treatment of ES-SCLC in combination with SoC chemotherapy in the US and Singapore. The approval is based on results from the Phase III PACIFIC trial. This website is intended for people seeking information on AstraZeneca's worldwide business. You are about to access AstraZeneca historic archive material. The most common Grade 3 or 4 adverse reaction (≥3%) was fatigue/asthenia (3.4%) In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), IMFINZI was discontinued due to adverse reactions in 7% of the patients receiving IMFINZI plus chemotherapy. 3. Journal of Oncology Practice, volume 14, issue no. Ellison G, et al. AstraZeneca is not responsible for the privacy policy of any third party websites. This was granted in the interest of public health because the medicine addresses an . Imfinzi is the only immunotherapy to show both a significant survival benefit and improved response rate in combination with chemotherapy for these patients, an important step forward in treating this devastating disease.”, Jonathan Goldman, MD, Associate Professor of Hematology & Oncology, UCLA Medical Center, Santa Monica, California and a lead investigator in the Phase III CASPIAN trial, said: “Patients with extensive-stage small cell lung cancer continue to face a poor prognosis, and finding new medicines to improve outcomes in this setting has been a formidable challenge. Keedy VL, et al. 10. Imfinzi is also approved for previously treated patients with advanced bladder cancer in the US and a small number of other countries. Great news for our patients….and their doctors as a new therapeutic option available! Ustekinumab yesterday approved by EMA for patients with moderate to severe ptients with Ulcerative colitis! Szumera-Ciećkiewicz A, et al. Tremelimumab is a human monoclonal antibody and potential new medicine that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). SCLC is a highly aggressive, fast-growing form of lung cancer that typically recurs and progresses rapidly despite initial response to chemotherapy.1,2, Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: “The US approval of Imfinzi brings a new medicine to extensive-stage small cell lung cancer patients in urgent need of new options. AstraZeneca provides this link as a service to website visitors. It follows the recommendation for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency in July 2020. Details will be presented at a forthcoming medical meeting. September 1, 2020. Available at https://www.cancer.net/cancer-types/33776/view-all. The CASPIAN trial enables clinicians to choose durvalumab in combination with etoposide and either carboplatin or cisplatin, making this an important new 1st-line treatment option for patients that is both effective and well-tolerated.”, The Phase III CASPIAN trial had two primary endpoints comparing experimental arms to SoC. As part of a broad development programme, Imfinzi is also being tested following concurrent chemoradiation therapy in patients with limited-stage SCLC in the Phase III ADRIATIC trial with data anticipated in 2021. 5. Lung Cancer – Small Cell. Int J Clin Exp Pathol. CASPIAN wasn’t all positive for AZ however, as a combination arm looking at Imfinzi with experimental CTLA4 inhibitor tremelimumab and chemo – reported earlier this month – failed to show any benefit over chemo alone. Accessed March 2020. Find out the latest on the safety profiles of COVID-19 vaccines from BioNTech, Moderna and AstraZeneca in our vaccine safety update reports, EMA’s human medicines committee (CHMP) has adopted several important recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the EU, EMA’s human medicines committee (CHMP) recommended five medicines for approval at its 22-25 March 2021 meeting. World Health Organization. An extensive late-stage Immuno-Oncology programme focuses on lung cancer patients without a targetable genetic mutation which represents up to three-quarters of all patients with lung cancer.10 Imfinzi, an anti-PDL1 antibody, is in development for patients with advanced disease (Phase III trials POSEIDON and PEARL) and for patients in earlier stages of disease including potentially-curative settings (Phase III trials AEGEAN, ADJUVANT BR.31, PACIFIC-2, PACIFIC-4, PACIFIC-5, and ADRIATIC) both as monotherapy and in combination with tremelimumab and/or chemotherapy. The Committee recommended granting a marketing authorisation for Copiktra (duvelisib) for the... Last week, EMA’s safety committee, PRAC, concluded its preliminary review of cases of blood clots, including very rare cases of blood clots with unusual features such as low numbers of platelets, in people vaccinated with Vaxzevria (previously COVID... EMA has reviewed the latest evidence on the use of ivermectin for the prevention and treatment of COVID-19 and concluded that the available data do not support its use for COVID-19 outside well-designed clinical trials. ERC Belgium has asked the European Medicines Agency (EMA) to give conditional approval to its investigational anti-cancer vaccine Gliovac (ERC1671) for the treatment of recurrent glioblastoma, an aggressive form of brain cancer. JCI Insight. Lurbinectedin could represent a potential new treatment for patients with SCLC, who have few options especially in the event of a relapse, and is being investigated in combination with doxorubicin as second-line therapy in a randomised phase 3 trial. Czech PM says Sputnik V can be used not waiting for EMA approval In a couple of months other EU member states will want to have Sputnik V, said Andrej Babis Read more Defense firm … Enhertu (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate is in development for metastatic non-squamous HER2-overexpressing or HER2-mutated NSCLC including trials in combination with other anticancer treatments. 2013:6;2800-12. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Imfinzi in combination with etoposide and either carboplatin or cisplatin is currently under regulatory review for the treatment of ES-SCLC in the 1st-line setting based on the Phase III CASPIAN trial in the EU and Japan. Results also showed an increased confirmed objective response rate in the Imfinzi plus SoC arm (68% versus 58% for SoC alone). Paz-Ares, L. et al. EGFR Mutation Testing on Cytological and Histological Samples in Non-Small Cell Lung Cancer: a Polish, Single Institution Study and Systematic Review of European Incidence. Regarding safety, the immune-related adverse events (irAEs) from the chemo-immunotherapy in ES-SCLC had a mild impact on the overall toxicity, without any significant difference in grade 3–4 AEs as … Imfinzi is also approved for previously treated patients with advanced bladder cancer in the US and several other countries. The approval by the Food and Drug Administration was based on positive results from the Phase III CASPIAN trial showing Imfinzi in combination with SoC platinum-etoposide demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus SoC alone. The second experimental arm testing tremelimumab added to Imfinzi and SoC recently completed, but did not meet its primary endpoint. We aim to address the unmet needs of patients with EGFR-mutated tumours as a genetic driver of disease, which occur in 10-15% of NSCLC patients in the US and EU and 30-40% of NSCLC patients in Asia, with the approved medicines Iressa (gefitinib) and Tagrisso (osimertinib), and its ongoing Phase III trials ADAURA, LAURA, and FLAURA2.7-9 We are also committed to addressing tumour mechanisms of resistance through the ongoing Phase II trials SAVANNAH and ORCHARD which test Tagrisso in combination with savolitinib, a selective inhibitor of c-MET receptor tyrosine kinase, along with other potential new medicines. Available at https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer. EGFR Mutation Testing in Lung Cancer: A Review of Available Methods and Their Use for Analysis of Tumour Tissue and Cytology Samples. The trial was conducted in more than 200 centres across 23 countries, including the US, in Europe, South America, Asia and the Middle East. The Company’s IO portfolio is anchored by immunotherapies that have been designed to overcome anti-tumour immune suppression. Although the European Medicines Agency's (EMA) offices will be closed from 18:30 on Wednesday 31 March until 07:30 on Tuesday 6 April 2021, remote working is still being enabled. The CASPIAN trial results were presented in September at the World Conference on Lung Cancer (WCLC) in Barcelona, Spain, and published October 4 in The Lancet. Atezolizumab received FDA approval in March 2019 and EMA approval in July 2019, whereas durvalumab was approved by FDA in March 2020, both as first-line therapy for ED-SCLC []. 6. Tremelimumab is being tested in a clinical trial programme in combination with Imfinzi in NSCLC, SCLC, bladder cancer, head and neck cancer and liver cancer. Accessed March 2020. Kalemkerian GP, et al. Personalized Therapy for Lung Cancer: Striking a Moving Target. As part of a broad development programme, Imfinzi is also being tested as a monotherapy and in combination with tremelimumab, an anti-CTLA4 monoclonal antibody and potential new medicine, as a treatment for patients with NSCLC, SCLC, bladder cancer, head and neck cancer, liver cancer, biliary tract cancer, cervical cancer and other solid tumours. Additionally, it is approved in the US, the EU, Japan and several other countries around the world for the treatment of ES-SCLC based on the CASPIAN Phase III trial. Pakkala, S, et al. For details on how to contact the Investor Relations Team, please click here. — Silvio Danese (@silvio_silvio75) Imfinzi is approved in the curative-intent setting of unresectable, Stage III NSCLC after chemoradiation therapy in the US, Japan, China, across the EU and in many other countries, based on the Phase III PACIFIC trial. By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death. In CASPIAN, the addition of durvalumab to platinum–etoposide as first-line treatment for patients with ES-SCLC resulted in consistent and durable clinical benefit across overall survival, progression-free survival, and objective At the same time, it has not yet received approval from the EU regulator. “CASPIAN underlines the therapeutic value of chemoimmunotherapy in patients with [advanced] SCLC as a new standard of care,” wrote Thorsten Oliver Goetze, M.D., of the Institute of Clinical Cancer Research in Frankfurt, Germany, … 2018;3(15):e120858. Find all the latest news and updates published on this website in one place. The proposed indication is supported by study D419QC00001 (CASPIAN), an … J Clin Pathol. 6 (June 1, 2018) 369-370. 2011:29;2121-27. The approval by the Food and Drug Administration was based on positive results from the Phase III CASPIAN trial showing Imfinzi in combination with SoC platinum-etoposide demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus SoC alone. Monday, December 02, 2019. AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal and Metabolism, and Respiratory. AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients' lives and the Company's future. In the experimental arms, patients were treated with four cycles of chemotherapy. AstraZeneca believes that IO-based therapies offer the potential for life-changing cancer treatments for the clear majority of patients. Imfinzi is also in development in the Phase II combination trials NeoCOAST, COAST and HUDSON in combination with potential new medicines from the early-stage pipeline. A video recording and presentation slides are now available from EMA’s public meeting on COVID-19 vaccines on 26 March. Enhertu can only be obtained with a prescription. American Society of Clinical Oncology Provisional Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for Patients with Advanced Non-Small-Cell Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor Therapy. Annex 1 - Detailed information on conditional marketing authorisations 3. 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 … J Clin Oncol. LUNGevity Foundation. Cancer.Net. The CASPIAN trial used a fixed dose of Imfinzi (1500mg) administered every three weeks for four cycles while in combination with chemotherapy and then every four weeks until disease progression. Treatment Options for Relapsed Small-Cell Lung Cancer: What Progress Have We Made? Adrian Kemp Any reference in these archives to AstraZeneca products or their uses may not reflect current medical knowledge and should not be used as a source of information on the present product label, efficacy data or safety data. Our country sites can be located in the AZ Network. Click ‘cancel’ to return to AstraZeneca’s site or ‘continue’ to proceed. The Lancet, 2019;394(10212):1929-1939. Featured news and updates for patients and carers, Featured news and updates for healthcare professionals, including doctors, nurses and pharmacists, Featured news and updates for animal health professionals and users of veterinary medicines such as pet owners, Featured news and updates for pharmaceutical industry stakeholders active in the human and veterinary medicines fields, Featured news and updates for journalists with a professional interest in the development and availability of medicines in the European Union, Featured news and updates for European academics and researchers in the field of medicine development. In comparison, the control arm allowed up to six cycles of chemotherapy and optional prophylactic cranial irradiation. It should be prescribed by a doctor and given under the supervision of a healthcare professional who has experience in the use of cancer medicines. EMA’s human medicines committee (CHMP) recommended five medicines for approval at its 22-25 March 2021 meeting Advice on use of ivermectin against COVID-19 COVID-19 | Treatments Available at http://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf. Accessed March 2020. 9. Types of Lung Cancer. The Imfinzi plus SoC data from the CASPIAN trial were published in The Lancet.3. Accessed March 2020. In the Imfinzi plus SoC arm, the risk of death was reduced by 27% (equal to a hazard ratio of 0.73; 95% CI 0.59-0.91; p=0.0047), with median OS of 13.0 months versus 10.3 months for SoC alone. -. AstraZeneca has announced that Imfinzi (durvalumab) has been approved in the EU as a first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin. Company Secretary