Imfinzi as monotherapy or in combination with tremelimumab was evaluated for survival outcomes in the DANUBE phase 3 trial in patients with locally advanced or metastatic urothelial carcinoma across 23 countries. Approximately 6.3% of men and women will be diagnosed with lung and bronchus cancer at … Lung cancer is the leading cause of cancer-related mortality in the U.S. AstraZeneca (AZ) has announced the voluntary withdrawal of its immunotherapy Imfinzi in its advanced bladder cancer indication in the US. The statement from Dave Fredrickson, executive vice president, oncology business unit of AstraZeneca, in a press release was not dissimilar from what Roche’s Garrraway had said. How to Work With Your Health Insurance Plan, Questions to Ask about Treatment Clinical Trials, Drugs Approved for Different Types of Cancer, Drugs Approved for Conditions Related to Cancer, U.S. Department of Health and Human Services. 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). and a collection of links to more information about the use of People given this combo treatment in the MERECA trial (NCT02432846) lived 10 months longer than those on Sutent alone. It is not a substitute for medical advice. Durvalumab is approved to treat: Non-small cell lung cancer (NSCLC). “While the withdrawal in previously treated metastatic bladder cancer is disappointing, we respect the principles FDA set out when the accelerated approval pathway was founded and remain committed to bringing new and innovative options to patients,” said Fredrickson via a press release. “In the last three years, Imfinzi has become an important standard of care in multiple lung cancer settings, an area of considerable focus for AstraZeneca.” Related Johnson & Johnson’s Covid-19 vaccine receives interim order authorisation in Canada Patients with metastatic bladder cancer currently being treated with Imfinzi should consult with their healthcare provider regarding their ongoing care. Radiation therapy may be necessary to kill remaining cancer cells, but it is usually delayed for at least a month while the surgical wound heals. MedlinePlus Information on Durvalumab - A lay language summary of important information about this drug that may include the following: Drugs are often studied to find out if they can help treat or prevent conditions other than the ones they are approved for. Definition from the NCI Drug Dictionary - Detailed scientific definition and other names for this drug. AstraZeneca PLC said its cancer treatment Imfinzi missed its endpoint in a phase III trial on people suffering recurrent or metastatic head and neck cancer. In the intention-to-treat population, which reflects the most generalizable results, the median overall survival was 15.1 months in the Imfinzi plus tremelimumab group versus 12.1 months in the chemotherapy group.The results were not statistically significant and so show that Imfinzi did not improve survival outcomes. The withdrawal does not affect the indication for non-small cell lung cancer. The information may not cover all possible uses, actions, interactions, or side effects of this drug, or precautions to be taken while using it. Imfinzi is approved in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy in the EU, US, Japan, China and many other countries, based on the PACIFIC Phase III trial. 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). But continued approval of the indication was contingent upon the results of the phase 3 IMvigor211 trial, which failed to meet its primary end point of overall survival improvement in patients with tumors that express PD-L. AstraZeneca announced in February the voluntary withdrawal of Imfinzi indication in the U.S. for previously treated adult patients with locally advanced or metastatic bladder cancer. “While the withdrawal of Tecentriq for prior-platinum treated bladder cancer is disappointing, Tecentriq continues to demonstrate benefits across multiple cancer types and therefore remains a meaningful treatment option for many patients.”, The FDA initially granted accelerated approval for the indication for Tecentriq in 2016 for patients who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based neoadjuvant or adjuvant chemotherapy.2. Patients were randomized to receive Imfinzi monotherapy (1500 mg) administered intravenously (IV) every 4 weeks; durvalumab (1500 mg) plus tremelimumab (75 mg) administered by IV every 4 weeks for up to 4 doses, followed by Imfinzi maintenance (1500 mg) every 4 weeks; or standard of care chemotherapy. what you should tell your doctor before using this drug. The Lung Cancer Master Protocol, or Lung-MAP, is a precision medicine research study for people with advanced non-small cell lung cancer that has continued to grow after treatment. Imfinzi FDA Approval History. ; Small cell lung cancer in adults. this drug, research results, and ongoing clinical trials. Radiation for lung cancer. Revenues from Imfinzi, mainly used against certain types of lung cancer, gained 42% to $1.48 billion in the first nine months of 2020, its fastest growing product. Durvalumab Why Commemorate 50 Years of the National Cancer Act? All rights reserved. Durvalumab Plus Chemotherapy Improves Survival in Small Cell Lung Cancer, Trial Results Highlight Changing Lung Cancer Treatment Landscape. However, much of the information may also apply to unapproved uses that are being studied. Atezolizumab (Tecentriq) and durvalumab (Imfinzi) target PD-L1, a protein related to PD-1 that is found on some tumor cells and immune cells. Lung cancer staging is based on a series of tests that determine which type of the disease is involved, how big the primary (original) tumor is, and how far the cancer may or may not have spread (metastasized). what this drug is used for and how it is used. © 2021 MJH Life Sciences™ and Managed Healthcare Executive. This is called pleural effusion and may also cause shortness of breath, cough, and chest pain. Lung cancer is staged to describe the severity of the disease and, in turn, direct appropriate treatment. Imfinzi, an immunotherapy, was granted accelerated approval in May 2017 based on positive results from Study 1108, a phase I/II trial.However, continued approval was dependent on results from the DANUBE phase 3 trial, which did not meet its primary endpoints as seen in The Lancet Oncology. The withdrawal does not affect the indication for non-small cell lung cancer. Patients are assigned to different study drug combinations based on the results of genomic profiling of their tumors. Revenues from Imfinzi, mainly used against certain types of lung cancer, gained 42% to $1.48 billion in the first nine months of 2020, its fastest growing product. Blocking this protein can also help boost the immune response against cancer cells. is also being studied in the treatment of other types of 4.2 Posology and method of administration Treatment must be initiated and supervised by a physician experienced in the treatment of cancer. FDA label information for this drug is available at DailyMed. They will stay on the market for other indications. Complementary & Alternative Medicine (CAM), Coping with Your Feelings During Advanced Cancer, Emotional Support for Young People with Cancer, Young People Facing End-of-Life Care Decisions, Late Effects of Childhood Cancer Treatment, Tech Transfer & Small Business Partnerships, Frederick National Laboratory for Cancer Research, Milestones in Cancer Research and Discovery, Step 1: Application Development & Submission, National Cancer Act 50th Anniversary Commemoration. AstraZeneca announced in February the voluntary withdrawal of Imfinzi indication in the U.S. for previously treated adult patients with locally advanced or metastatic bladder cancer. Two weeks earlier, AstraZeneca announced that it was withdrawing the use of its checkpoint inhibitor Imfinzi (durvalumab) as a treatment for bladder cancer in the United States following a failure to meet endpoints in a post-approval clinical study. Despite the withdrawal, AZ still has several phase 3 trials testing Imfinzi in various treatment combinations for early- and late-stage bladder cancer. Imfinzi is a medicine used to treat a type of lung cancer called non-small cell lung cancer (NSCLC). The FDA’s Accelerated Approval Program enables earlier approval for medications treating serious conditions that fill an unmet medical need, and companies are required to continue studying whether the treatment offers clinical benefit in phase 4 confirmatory trials. “In the last three years, Imfinzi has become an important standard of care in multiple lung cancer settings, an area of considerable focus for AstraZeneca,” he added. FDA label information for this drug is available at DailyMed. Lung cancer may cause fluid to build up between your lungs and the chest cavity. FDA Approved: Yes (First approved May 1, 2017) Brand name: Imfinzi Generic name: durvalumab Dosage form: Injection Company: AstraZeneca Treatment for: Non-Small Cell Lung Cancer, Small Cell Lung Cancer Imfinzi (durvalumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated:. Patients with metastatic bladder cancer currently being treated with Imfinzi should consult with their healthcare provider regarding their ongoing care. cancer. All rights reserved. Drugmarkers have recently withdraw urothelial cancer indications from two important cancer medications. The median overall survival was 14.4 months in the Imfinzi monotherapy group versus 12.1 months in the chemotherapy group. Imfinzi is approved in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy in the EU, US, Japan, China and many other countries. © 2021 MJH Life Sciences and Managed Healthcare Executive. This patient information sheet applies only to approved uses of the drug. Additionally, it is approved in the EU, US, Japan and many other countries for the treatment of extensive-stage small cell lung cancer (SCLC). Roche announced in early March that it had voluntarily withdrawn the Tecentriq’s (atezolizumab) indication as a treatment for patients with locally advanced or metastatic urothelial carcinoma (mUC) previously treated with platinum-based chemotherapy. what you should know about this drug before using it, other drugs that may interact with this drug, and. Immunotherapy for lung cancer, alone or in combination with conventional treatments, can significantly improve outcomes for patients fighting lung cancer. After accelerated approval, both drugs fall short of overall survival endpoint. The US Food and Drug Administration (FDA) granted Imfinzi (durvalumab) an accelerated approval in May 2017 in advanced bladder cancer, after the Phase I/II Study 1108 of the immunotherapy demonstrated promising tumour response rates and duration of … Continued Thoracentesis. IMFINZI is a prescription medicine used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC).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. This page contains brief information about durvalumab About Small cell lung cancer SCLC is a highly aggressive, ... which represent up to three-quarters of all patients with lung cancer. Just over a thousand patients were randomly assigned to receive Imfinzi (346), Imfinzi plus tremelimumab (342), or chemotherapy (344). A combination of ilixadencel plus first-line treatment with Sutent (sunitinib) prolonged overall survival to a clinically meaningful extent in newly diagnosed patients with metastatic renal cell carcinoma (mRCC), a form of kidney cancer, a Phase 2 trial found. Find Clinical Trials for Durvalumab - Check for trials from NCI's list of cancer clinical trials now accepting patients. Accelerated approval was based on results of the phase 2 IMvigor210 trial, which showed promising responses in patients receiving second-line Tecentriq versus historical controls. Please see your health care professional for more information about your specific medical condition and the use of this drug. A 2016 study looking at people with different advanced cancers including melanoma, non-small cell lung cancer, small cell lung cancer, and breast cancer treated with checkpoint inhibitors found that pseudoprogression was relatively uncommon, but indicated a high likelihood that people would survive more than one year. “The Accelerated Approval Program allows people with difficult-to-treat cancers to receive certain new therapies earlier,” Levi Garraway, M.D., Ph.D., Roche’s chief medical officer and head of global product development, said in a press release. Important: The drug information on this page is meant to be educational. Use in Cancer. How to Reduce Maternal, Infant Health Risks During COVID-19. is approved to treat: Durvalumab We will continue to build on the established benefits of Imfinzi in early lung cancer and small cell lung cancer, to bring immunotherapy treatment options to all patients who may benefit.” About 750,000 patients were diagnosed with head and neck cancer globally last year. 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.