Francesco Pignatti

Summary

Affiliation: European Commission
Country: Belgium

Publications

  1. ncbi Prognostic factors for survival in adult patients with cerebral low-grade glioma
    Francesco Pignatti
    European Organization for Research and Treatment of Cancer Data Center, Brussels, Belgium
    J Clin Oncol 20:2076-84. 2002
  2. ncbi Clinical trials for registration in the European Union: the EMEA 5-year experience in oncology
    Francesco Pignatti
    The European Agency for the Evaluation of Medicinal Products, 7 Westferry Circus, Canary Wharf, London E14 4HB, UK
    Crit Rev Oncol Hematol 42:123-35. 2002
  3. ncbi Overview of the European regulatory approval system
    Francesco Pignatti
    European Agency for the Evaluation of Medicinal Products EMEA, Canary Wharf, London, United Kingdom
    J Ambul Care Manage 27:89-97. 2004
  4. doi The European Medicines Agency review of vemurafenib (Zelboraf®) for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma: summary of the scientific assessment of the Committee for Medicinal Products for Huma
    Silvy da Rocha Dias
    European Medicines Agency, London, United Kingdom
    Eur J Cancer 49:1654-61. 2013
  5. ncbi The review of drug applications submitted to the European Medicines Evaluation Agency: frequently raised objections, and outcome
    Francesco Pignatti
    Safety and Efficacy, Oncology, European Agency for the Evaluation of Medicinal Products, 7 Westferry Circus, Canary Wharf, London E14 4HB, UK
    Eur J Clin Pharmacol 58:573-80. 2002
  6. doi The European medicines agency review of eribulin for the treatment of patients with locally advanced or metastatic breast cancer: summary of the scientific assessment of the committee for medicinal products for human use
    Elias Pean
    European Medicines Agency, London, United Kingdom
    Clin Cancer Res 18:4491-7. 2012
  7. pmc The European medicines agency review of pomalidomide in combination with low-dose dexamethasone for the treatment of adult patients with multiple myeloma: summary of the scientific assessment of the committee for medicinal products for human use
    Zahra Hanaizi
    European Medicines Agency, London, United Kingdom Medicines and Healthcare Products Regulatory Agency, London, United Kingdom Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain Läkemedelsverket, Medical Products Agency, Uppsala, Sweden Hôpital Saint Louis, Paris, France North Estonia Regional Hospital, Tallinn, Estonia
    Oncologist 20:329-34. 2015
  8. pmc The European Medicines Agency review of pixantrone for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin's B-cell lymphomas: summary of the scientific assessment of the committee for medicinal products for human u
    Elias Pean
    European Medicines Agency, London, United Kingdom
    Oncologist 18:625-33. 2013
  9. pmc The European medicines agency review of abiraterone for the treatment of metastatic castration-resistant prostate cancer in adult men after docetaxel chemotherapy and in chemotherapy-naive disease: summary of the scientific assessment of the committee for
    Iordanis Gravanis
    European Medicines Agency, London, United Kingdom
    Oncologist 18:1032-42. 2013
  10. pmc The European Medicines Agency review of cabazitaxel (Jevtana®) for the treatment of hormone-refractory metastatic prostate cancer: summary of the scientific assessment of the committee for medicinal products for human use
    Elias Pean
    European Medicines Agency, 7 Westferry Circus, London E14 4HB, UK
    Oncologist 17:543-9. 2012

Collaborators

Detail Information

Publications20

  1. ncbi Prognostic factors for survival in adult patients with cerebral low-grade glioma
    Francesco Pignatti
    European Organization for Research and Treatment of Cancer Data Center, Brussels, Belgium
    J Clin Oncol 20:2076-84. 2002
    ..To identify prognostic factors for survival in adult patients with cerebral low-grade glioma (LGG), to derive a prognostic scoring system, and to validate results using an independent data set...
  2. ncbi Clinical trials for registration in the European Union: the EMEA 5-year experience in oncology
    Francesco Pignatti
    The European Agency for the Evaluation of Medicinal Products, 7 Westferry Circus, Canary Wharf, London E14 4HB, UK
    Crit Rev Oncol Hematol 42:123-35. 2002
    ....
  3. ncbi Overview of the European regulatory approval system
    Francesco Pignatti
    European Agency for the Evaluation of Medicinal Products EMEA, Canary Wharf, London, United Kingdom
    J Ambul Care Manage 27:89-97. 2004
    ..This article presents the available systems for drug approval in the EU together with the changes proposed for the future...
  4. doi The European Medicines Agency review of vemurafenib (Zelboraf®) for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma: summary of the scientific assessment of the Committee for Medicinal Products for Huma
    Silvy da Rocha Dias
    European Medicines Agency, London, United Kingdom
    Eur J Cancer 49:1654-61. 2013
    ..The full scientific assessment report and product information, including the Summary of Product Characteristics (SmPC), are available on the EMA website (www.ema.europa.eu)...
  5. ncbi The review of drug applications submitted to the European Medicines Evaluation Agency: frequently raised objections, and outcome
    Francesco Pignatti
    Safety and Efficacy, Oncology, European Agency for the Evaluation of Medicinal Products, 7 Westferry Circus, Canary Wharf, London E14 4HB, UK
    Eur J Clin Pharmacol 58:573-80. 2002
    ..To study the issues raised during the review of drug applications submitted to the European Medicines Evaluation Agency for approval in the European Union and to identify important predictors of outcome...
  6. doi The European medicines agency review of eribulin for the treatment of patients with locally advanced or metastatic breast cancer: summary of the scientific assessment of the committee for medicinal products for human use
    Elias Pean
    European Medicines Agency, London, United Kingdom
    Clin Cancer Res 18:4491-7. 2012
    ..The detailed scientific assessment report and product information, including the summary report and product information, including product characteristics, are available on the European Medicines Agency website...
  7. pmc The European medicines agency review of pomalidomide in combination with low-dose dexamethasone for the treatment of adult patients with multiple myeloma: summary of the scientific assessment of the committee for medicinal products for human use
    Zahra Hanaizi
    European Medicines Agency, London, United Kingdom Medicines and Healthcare Products Regulatory Agency, London, United Kingdom Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain Läkemedelsverket, Medical Products Agency, Uppsala, Sweden Hôpital Saint Louis, Paris, France North Estonia Regional Hospital, Tallinn, Estonia
    Oncologist 20:329-34. 2015
    ..The detailed scientific assessment report and product information, including the summary of product characteristics, are available on the EMA website (http://www.ema.europa.eu). ..
  8. pmc The European Medicines Agency review of pixantrone for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin's B-cell lymphomas: summary of the scientific assessment of the committee for medicinal products for human u
    Elias Pean
    European Medicines Agency, London, United Kingdom
    Oncologist 18:625-33. 2013
    ..The detailed scientific assessment report and product information, including the summary of product characteristics, are available on the European Medicines Agency website (http://www.ema.europa.eu)...
  9. pmc The European medicines agency review of abiraterone for the treatment of metastatic castration-resistant prostate cancer in adult men after docetaxel chemotherapy and in chemotherapy-naive disease: summary of the scientific assessment of the committee for
    Iordanis Gravanis
    European Medicines Agency, London, United Kingdom
    Oncologist 18:1032-42. 2013
    ..These were generally manageable with basic medical interventions. The most common side effects (affecting more than 10% of patients) were urinary tract infection, hypokalemia, hypertension, and peripheral edema. ..
  10. pmc The European Medicines Agency review of cabazitaxel (Jevtana®) for the treatment of hormone-refractory metastatic prostate cancer: summary of the scientific assessment of the committee for medicinal products for human use
    Elias Pean
    European Medicines Agency, 7 Westferry Circus, London E14 4HB, UK
    Oncologist 17:543-9. 2012
    ..The detailed scientific assessment report and product information, including the summary of product characteristics, are available on the European Medicines Agency Web site (http://www.ema.europa.eu)...
  11. doi The European Medicines Agency: an overview of its mission, responsibilities, and recent initiatives in cancer drug regulation
    Francesco Pignatti
    European Medicines Agency, London, United Kingdom
    Clin Cancer Res 17:5220-5. 2011
    ..The current revision will address a number of topics, including the use of biomarkers as an integrated part of drug development and the use of progression-free survival as a primary endpoint in registration trials...
  12. doi The European Medicines Agency review of ipilimumab (Yervoy) for the treatment of advanced (unresectable or metastatic) melanoma in adults who have received prior therapy: summary of the scientific assessment of the Committee for Medicinal Products for Hum
    Zahra Hanaizi
    European Medicines Agency, London, United Kingdom
    Eur J Cancer 48:237-42. 2012
    ..The detailed scientific assessment report and product information, including the summary of product characteristics (SmPC), are available on the European Medicines Agency (EMA) website (www.ema.europa.eu)...
  13. doi The European Medicines Agency review of pazopanib for the treatment of advanced renal cell carcinoma: summary of the scientific assessment of the Committee for Medicinal Products for Human Use
    Maria Nieto
    European Medicines Agency, London, United Kingdom
    Clin Cancer Res 17:6608-14. 2011
    ..The objective of this article is to summarize the scientific review of the application that led to approval in the European Union...
  14. pmc The European Medicines Agency review of Tegafur/Gimeracil/Oteracil (Teysuno™) for the treatment of advanced gastric cancer when given in combination with cisplatin: summary of the Scientific Assessment of the Committee for medicinal products for human use
    Petra Matt
    European Medicines Agency, London, UK
    Oncologist 16:1451-7. 2011
    ..The full scientific assessment report and the summary of product characteristics are available on the European Medicines Agency website (http://www.ema.europa.eu)...
  15. doi The European Medicines Agency approval of ingenol mebutate (Picato) for the cutaneous treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis in adults: Summary of the scientific assessment of the Committee for Medicinal Products for Human Use
    Kyriaki Tzogani
    European Medicines Agency, 7 Westferry Circus, London, E14 4HB, UK
    Eur J Dermatol 24:457-63. 2014
    ..The European Commission has recently issued a marketing authorisation valid throughout the European Union for ingenol mebutate (Picato) in the cutaneous treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis in adults...
  16. pmc The European Medicines Agency approval of axitinib (Inlyta) for the treatment of advanced renal cell carcinoma after failure of prior treatment with sunitinib or a cytokine: summary of the scientific assessment of the committee for medicinal products for
    Kyriaki Tzogani
    European Medicines Agency, London, United Kingdom Statens Legemiddelverk, Norwegian Medicines Agency, Oslo, Norway Lægemiddelstyrelsen, Danish Health and Medicines Authority, København, Denmark Läkemedelsverket, Medicinal Products Agency, Uppsala, Sweden Universitair Ziekenhuis, Ghent, Belgium European Organization for Research and Treatment of Cancer EORTC, Brussels, Belgium Centrum für Operative Urologie Bremen, Bremen, Germany Karolinska Institute and Hospital, Stockholm, Sweden
    Oncologist 20:196-201. 2015
    ..The detailed scientific assessment report and product information, including the summary of product characteristics, are available on the EMA website (http://www.ema.europa.eu). ..
  17. doi The changing world of cancer drug development: the regulatory bodies' perspective
    Iordanis Gravanis
    European Medicines Agency, London, UK
    Chin Clin Oncol 3:22. 2014
    ..Discovery of novel therapeutic modalities, including new drugs targeting cancer, is undoubtedly of major public health interest...
  18. pmc The European Medicines Agency review of eltrombopag (Revolade) for the treatment of adult chronic immune (idiopathic) thrombocytopenic purpura: summary of the scientific assessment of the Committee for Medicinal Products for Human Use
    Maria Nieto
    European Medicines Agency, London, UK
    Haematologica 96:e33-40. 2011
    ..The detailed scientific assessment report and product information, including the summary of product characteristics, are available on the European Medicines Agency website (www.ema.europa.eu)...
  19. pmc The European Medicines Agency review of ofatumumab (Arzerra®) for the treatment of chronic lymphocytic leukemia in patients refractory to fludarabine and alemtuzumab: summary of the scientific assessment of the European medicines agency committee for medi
    Iordanis Gravanis
    European Medicines Agency, London, UK
    Oncologist 15:1335-43. 2010
    ..The detailed scientific assessment report and product information, including the summary of product characteristics, are available on the EMA website (http://www.ema.europa.eu)...
  20. doi Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma
    Hans Georg Eichler
    European Medicines Agency, Canary Wharf, London, UK
    Nat Rev Drug Discov 7:818-26. 2008
    ....