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Darolutamide (Nubeqa) - non-metastatic castration-resistant prostate cancer (nmCRPC) Search Page - Drug and Health Product Register Language selection Search and menus Search Search website Search Topics menu You are here: Summary Basis of Decision - - Health Canada Expand all Summary Basis of Decision (SBD) for Contact: Summary Basis of Decision (SBD) documents provide information related to the original authorization of a product. The for is located below. Recent Activity for SBDs written
TULSA-PRO system - prostate cancer Search Page - Drug and Health Product Register Language selection Search and menus Search Search website Search Topics menu You are here: Summary Basis of Decision - - Health Canada Expand all Summary Basis of Decision (SBD) for Contact: Summary Basis of Decision (SBD) Summary basis of decision (SBD) documents provide information related to the original authorization of a product. The for the is located below. Updated: The following table describes post
Trastuzumab (Kanjinti) - breast cancer Search Page - Drug and Health Product Register Language selection Search and menus Search Search website Search Topics menu You are here: Summary Basis of Decision - - Health Canada Expand all Summary Basis of Decision (SBD) for Contact: Summary Basis of Decision (SBD) documents provide information related to the original authorization of a product. The for is located below. Recent Activity for SBDs written for approved after September 1, 2012
Lurbinectedin (Zepzelca) - To treat metastatic small cell lung cancer Drug Approval Package: ZEPZELCA U.S. Department of Health and Human Services Search FDA Submit search Drug Approval Package: ZEPZELCA Company: Pharma Mar USA, Inc. Application Number: 213702 Approval Date: 06/15/2020 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. FDA Approval Letter and Labeling (PDF) (PDF) FDA Application Review Files (PDF) (PDF) (PDF) (PDF
Fluoroestrdiol F18 (Cerianna) - Diagnostic imaging agent for certain patients with breast cancer Drug Approval Package: CERIANNA U.S. Department of Health and Human Services Search FDA Submit search Drug Approval Package: CERIANNA Company: Zionexa-US Corporation Application Number: 212155 Approval Date: 05/20/2020 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. FDA Approval Letter and Labeling (PDF) (PDF) FDA Application Review
Ripretinib (Qinlock) - To treat advanced gastrointestinal-stromal tumors Drug Approval Package: QINLOCK U.S. Department of Health and Human Services Search FDA Submit search Drug Approval Package: QINLOCK Company: Deciphera Pharmaceuticals, LLC Application Number: 213973 Approval Date: 05/15/2020 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. FDA Approval Letter and Labeling (PDF) (PDF) FDA Application Review Files (PDF) (PDF
to be in Barcelona Clinic Liver Cancer (BCLC) stage C. Patients in BCLC stage B could also be eligible if their disease was not amenable or refractory to locoregional therapy. Patients Extract of dossier assessment A19-73 Version 1.0 Ramucirumab (hepatocellular carcinoma) 28 November 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - 2 - with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 and with only mild liver impairment (Child Pugh class A) were enrolled (...) in BCLC stage C at randomization; patients in BCLC stage B could be eligible if their disease was not amenable or refractory to locoregional therapy. c: Patients with fibrolamellar carcinoma were excluded from the study. d: In the absence of a histologically confirmed diagnosis, patients had to have clinical, biochemical or radiological findings consistent with the diagnosis of liver cirrhosis on study entry, and a liver mass measuring at least 2 cm with characteristic vascularization seen on either
Olaparib (breast cancer) - Addendum to Commission A19-57 1 Translation of addendum A19-97 Olaparib (Mammakarzinom) – Addendum zum Auftrag A19-97 (Version 1.0; Status: 12 December 2019). Please note: This translation is provided as a service by IQWiG to English- language readers. However, solely the German original text is absolutely authoritative and legally binding. Addendum 12 December 2019 1.0 Commission: A19-97 Version: Status: IQWiG Reports – Commission No. A19-97 Olaparib (breast cancer (...) ) – Addendum to Commission A19-57 1 Addendum A19-97 Version 1.0 Olaparib – Addendum to Commission A19-57 12 December 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher Institute for Quality and Efficiency in Health Care Topic Olaparib (breast cancer) – Addendum to Commission A19-57 Commissioning agency Federal Joint Committee Commission awarded on 26 November 2019 Internal Commission No. A19-97 Address of publisher Institut für Qualität und
treatment ? any tumour treatment until disease progression and discontinuation of the study medication ? denosumab c Extract of dossier assessment A19-86 Version 1.0 Atezolizumab (small cell lung cancer) 13 January 2020 Institute for Quality and Efficiency in Health Care (IQWiG) - 11 - Table 7: Characteristics of the intervention – RCT, direct comparison: atezolizumab + carboplatin + etoposide versus placebo + carboplatin + etoposide(multipage table) Study Intervention Comparison a. Treatment could (...) of the best supportive care (BSC) during the maintenance phase. Extract of dossier assessment A19-86 Version 1.0 Atezolizumab (small cell lung cancer) 13 January 2020 Institute for Quality and Efficiency in Health Care (IQWiG) - 12 - Treatment was performed until disease progression, unacceptable toxicity, start of another tumour therapy, withdrawal of consent or death; administration of atezolizumab could be continued beyond progression at the investigator’s discretion if clinical benefit continued
und REACH-2 6 Addendum A20-03 Version 1.0 Ramucirumab – Addendum to Commission A19-73 30 January 2020 Institute for Quality and Efficiency in Health Care (IQWiG) - vi - List of abbreviations Abbreviation Meaning AFP alpha fetoprotein BSC best supportive care FACT Functional Assessment of Cancer Therapy FHSI-8 FACT Hepatobiliary Symptom Index-8 G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee) HCC hepatocellular carcinoma IQWiG Institut für Qualität und Wirtschaftlichkeit im (...) Ramucirumab (hepatocellular carcinoma) - Addendum to Commission A19-73 1 Translation of addendum A20-03 Ramucirumab (hepatozelluläres Karzinom) – Addendum zum Auftrag A19-73 (Version 1.0; Status: 30 January 2020). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Addendum 30 January 2020 1.0 Commission: A20-03 Version: Status: IQWiG Reports – Commission No. A20-03
: appropriate comparator therapy; G-BA: Federal Joint Committee; SPC: Summary of Product Characteristics According to the S3 guideline “Diagnostics, Therapy and Follow-up of Malignant Ovarian Tumours”, cancers of the ovaries, fallopian tubes, and peritoneum are jointly classified in case of the same pathogenesis and histomorphology . In the present dossier assessment, the term “ovarian cancer” therefore includes ovarian, fallopian tube and peritoneal cancer. From the options presented, the company chose (...) assessment. IQWiG employees involved in the dossier assessment ? Bent Müller ? Christiane Balg ? Tatjana Herrmanns ? Corinna Kiefer ? Katrin Nink ? Sabine Ostlender ? Volker Vervölgyi ? Carolin Weigel Keywords: Niraparib, Ovarian Neoplasms, Benefit Assessment, NCT01847274, NCT00753545, NCT01874353 Extract of dossier assessment A19-88 Version 1.0 Niraparib (ovarian cancer) 13 January 2020 Institute for Quality and Efficiency in Health Care (IQWiG) - iii - Table of contents Page List of tables iv List
of rapid report D19-01 Version 1.1 Biomarkers in breast cancer 26 February 2020 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - This report was prepared without the involvement of external experts. IQWiG employees ? Martina Markes ? Katrin Dreck ? Daniel Fleer ? Elke Hausner ? Fabian Lotz Keywords: Tumour Markers – Biological, Breast Neoplasms, Systematic Review Extract of rapid report D19-01 Version 1.1 Biomarkers in breast cancer 26 February 2020 Institute for Quality (...) for or against adjuvant systemic chemotherapy compared with a biomarker-independent decision strategy ? in patients with primary hormone receptor-positive, HER2-negative breast cancer and 0 to 3 affected lymph nodes taking into account the following aspects: ? the biomarker-based tests uPa/PAI-1 (Femtelle), Oncotype DX, EndoPredict / EPclin, MammaPrint, Breast Cancer Index, Prosigna, and the IHC4 test, ? the outcomes of overall survival, disease-free survival and recurrence-free survival, each over a period
Niraparib (ovarian cancer) - Addendum to Commission A19-88 www.iqwig.de - 404 - Seite nicht gefunden accessibility.navigation.meta IQWiG accessibility.navigation.main Brotkrumenpfad 404 - Seite nicht gefunden Seite nicht gefunden Die von Ihnen aufgerufene Seite existiert leider nicht. Bitte verwenden Sie die Navigation oder unsere , um den gewünschten Inhalt zu finden. Falls Sie Fragen haben, können Sie sich auch direkt über unser an uns wenden. Suche Suche Weitere Informationen Der IQWiG
with the appropriate comparator therapy (ACT) for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in adult patients whose tumours have Programmed Cell Death-Ligand 1 (PD-L1) expression = 1% and who have not received prior chemotherapy for the treatment of their metastatic disease. The research question for the benefit assessment presented in Table 2 resulted from the ACT specified by the G-BA. Table 2: Research question of the benefit assessment of atezolizumab (...) Neoplasms, Benefit Assessment, NCT02425891 Extract of dossier assessment A19-81 Version 1.0 Atezolizumab (breast cancer) 20 December 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - iii - Table of contents Page List of tables iv List of abbreviations v 2 Benefit assessment 1 2.1 Executive summary of the benefit assessment 1 2.2 Research question 4 2.3 Information retrieval and study pool 3 2.4 Results on added benefit 4 2.5 Probability and extent of added benefit 4 2.6 List of included
(0) Liver carcinoma 1 1.12 [1.12; 1.12] 1 (100) Prostate cancer 1 NA [6.44 b ; 6.44 b ] 0 (0) Cancer of unknown primary 1 11.96 [11.96; 11.96] 1 (100) Primary CNS tumour d 24 NA [1.9 b ; 21.4 b ] 1 (4) a. Data are based on the ePAS4 population: patients with NTRK gene fusion (except patients with primary CNS tumours) who meet the following criteria: administration of = 1 dose of larotrectinib, = 1 measurable lesion at baseline as evaluated by the investigator, IRC assessment available. b (...) cancer b 15 15 (100) Colorectal cancer 8 8 (100) Thyroid cancer Melanoma 89 c 87 (98) c Breast cancer Gastrointestinal stromal tumour Bone sarcoma Cholangiocarcinoma Pancreatic cancer Appendix cancer Congenital mesoblastic nephroma Liver carcinoma Prostate cancerCancer of unknown primary Primary CNS tumour a. Information is based on the safety population with NTRK gene fusion (Overall NTRK Fusion Cancers Safety Set). This comprises all patients with NTRK gene fusion who had received = 1 dose
Is 45 really the new 50 in colorectal cancer screening? Tools for Practice is proudly sponsored by the Alberta College of Family Physicians (ACFP). ACFP is a provincial, professional voluntary organization, representing more than 4,800 family physicians, family medicine residents, and medical students in Alberta. Established over sixty years ago, the ACFP strives for excellence in family practice through advocacy, continuing medical education and primary care research. www.acfp.ca June 29, 2020 (...) Is 45 really the new 50 in colorectal cancer screening? Clinical Question: Should we lower the age that average risk patients commence colorectal cancer screening from 50 to 45? Bottom Line: In developed countries, the incidence of colorectal cancer in persons under 50 years old has increased by 20-30% in the last 20 years. However, the absolute risk increase is only 1-4 per 100,000 persons. Screening average risk patients under age 50 should not be encouraged at this time. Evidence: • Population
smokers, no significant risk of developing prostate or cervical cancer. Cohort study 133, 881 aged 25 and older Controlled for demographic and socioeconomic factors and alcohol and tobacco use Non users of cannabis vs. at least once per month use was associated with significant risk of malignant adult-onset glioma (RR 2.8 95%CI 1.3 to 6.2) Compared to non-users, users had significant risk of developing brain tumour with weekly cannabis use (RR 3.2 95%CI 1.1 to 9.2) or monthly cannabis use (RR, 3.6, 95 (...) ]. This consensus guideline covered 11 health topics: therapeutic effects, cancer, cardiometabolic risk, respiratory disease, immunity, injury and death, prenatal, perinatal, and postnatal exposure to cannabis, psychosocial, mental health, problem cannabis use, and cannabis use and abuse of other substances. For each health endpoint, the NASEM group identified systematic reviews and primary research literature up to August 1, 2016 and based their conclusions on all relevant fair- and good-quality systematic
. The 5-year net survival rate, estimated at 15%, is among the poorest of all cancer prognoses. Men have a higher incidence than women, with an estimated 9 cases versus 2 cases per 100 000, respectively. Adenocarcinoma is the most common type of esophageal cancer in Canada, followed by squamous cell carcinoma. Incidence has shifted over the past 40 years, with rates of adenocarcinoma increasing and squamous cell carcinoma falling ( ). This change may have resulted from increases in adenocarcinoma (...) -related risk factors (e.g., gastroesophageal reflux, obesity) and decreases in risk factors linked to squamous cell carcinoma (e.g., smoking). Thus, this guideline focuses on screening for esophageal adenocarcinoma. Figure 1: Age-standardized incidence rates* for esophageal adenocarcinoma (EAC) and esophageal squamous cell carcinoma (ESCC), all ages, Canada (excluding Quebec),† 1986 to 2015. Data source: Canadian Cancer Registry and National Cancer Incidence Reporting System databases at Statistics
Clinical Practice Guidelines – Prostate Cancer Prostate Cancer | ESMO Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly. MINIMAL Requirements: , , , , , Search Clinical Practice Guidelines – Prostate Cancer Published in 2020 – Ann Oncol (2020) Authors: C. Parker, E. Castro, K. Fizazi, A. Heidenreich, P. Ost, G. Procopio, B. Tombal & S. Gillessen Prostate cancer is reported as the second most common cancer in men. The updated (...) ESMO Clinical Practice Guidelines on prostate cancer provide information on the current management of prostate cancer including recommendations for screening and diagnosis, along with stage-matched therapeutic strategies. Related items Read full article Legal Useful links Subscribe to ESMO newsletters Receive information and updates on ESMO’s scientific and educational resources, events, members activities. To sign up for ESMO newsletters, and select the newsletters you’d like to receive. ESMO
Oncol 2014; 25 (Suppl 3): iii40–iii48. Section Management of advanced and metastatic disease Text update Chemotherapy (ChT) regimens recommendations for first-line advanced disease have not changed from the previous . Platinum-containing combination ChT is the standard of care for advanced or metastatic urothelial cancer (UC) [I, A] [1,2]. Gemcitabine with cisplatin or gemcitabine with carboplatin are the most widely used regimens. Six cycles of ChT is considered standard therapy. Maintenance (...) unknown or negative Gemcitabine/carboplatin [II, B] followed by maintenance avelumab for tumours which have not progressed on ChT [I, A] a Cisplatin ineligible and PD-L1-positive Gemcitabine/carboplatin [II, B] followed by maintenance avelumab for tumours which have not progressed on ChT [I, A] a or Atezolizumab or pembrolizumab [III, B] ChT, chemotherapy; PD-L1, programmed death-ligand 1; PS, performance status, UC, urothelial cancer. a Not approved by EMA b Creatinine clearance <60 ml/min or PS2