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This page brings together the Agency's latest information on cancer. It lists:

the ten newest and recently updated medicines authorised for the treatment of cancer in the European Union (EU);

the most recent opinions on anti-cancer medicines that are pending authorisation by the European Commission (EC);

the latest cancer-related news and press releases;

the Agency's events on cancer-related topics.

New and recently updated medicines

Opinions pending EC decision



  • 15/11/2016 - 16/11/2016


    Committee for Advanced Therapies (CAT) workshop: scientific and regulatory challenges of genetically modified cell-based cancer immunotherapy products

    The CAT is organising a two day workshop to discuss the scientific developments and regulatory requirements for products manufacture and testing, non-clinical studies and clinical development of genetically modified cell-based cancer immunotherapy products. These novel cancer immunotherapy treatments based on genetically modified T-cells are being developed and tested in clinical trials in a variety of cancers, but there are still scientific and regulatory challenges to overcome to bring these innovative products to the market. The workshop is available for participants from regulatory authorities, academia, hospitals, industry, journalists and interested members of the public. ... Read more

  • 30/06/2016


    Workshop on single-arm trials in oncology

    Situations in which a medicine shows significant anti-cancer activity in an area where patients have no treatment option or where the conduct of standard trials with a comparative arm is difficult, such as in rare cancers or selected populations for example, will be considered. Workshop participants will discuss experience gained so far with marketing authorisations based on single-arm trials data, the strengths and weaknesses of different approaches, and opportunities from data sharing initiatives. They will also explore the views of various stakeholders groups and discuss the need for further regulatory guidance with the ultimate aim of optimising the development of new cancer treatments in these situations. ... Read more

  • 04/02/2016 - 05/02/2016


    Workshop on the challenges for the approval of anti-cancer immunotherapeutic drugs

    Immunotherapy is becoming a fast growing area of new medicinal products in oncology. These new agents have brought important advances in patient care and have considerably changed the landscape of treatment options in melanoma and lung cancer patients. However, there are still many challenges on how to bring these agents through regulatory approval and into clinical practice. Appropriate patient population selection, new clinical trials designs, rational for the mechanism of action in different tumour types, innovative immunological-based products used in combination and assessing relative efficacy of these novel immunomodulating therapies are some of the key issues that we propose to address in a workshop organised with the Cancer Drug Development Forum (CDDF). The aim is to address these highly relevant issues and their impact on the regulatory environment. ... Read more

  • 30/04/2015


    European Medicines Agency (EMA)/European Society for Medical Oncology (ESMO) Rare Cancers Europe initiative: Joint workshop on chordoma as a model for very rare cancers

    Following the workshop on the methodology of clinical trials in rare cancers held in October 2014, the European Medicines Agency (EMA) and the European Society for Medical Oncology (ESMO) Rare Cancers Europe initiative will review a real case scenario on one single rare cancer and discuss together how to facilitate the development of promising therapies in spite of rarity. The aim of this workshop, which focuses on chordoma, is to discuss scientific and regulatory evidence requirements for rare diseases, main challenges and identify possible methodological solutions that could work for this and other very rare cancers. The meeting foresees the participation of oncologists, statisticians, methodologists, patient advocates and industry. A meeting report will be published on the EMA and ESMO websites. Registration by invitation only. Places limited. ... Read more

  • 03/12/2015 - 04/12/2015


    Innovation and Biomarkers in Cancer Drug Development (IBCD) 2015

    Innovation and Biomarkers in Cancer Drug Development (IBCD) 2015 will shine a spotlight on multi-stakeholder approaches to cancer drug development with new cancer biomarkers in a scientific programme which will include input from regulators, industry, academia, patients and payers. Without a doubt, the combined efforts of the European Organisation for Research and Treatment of Cancer (EORTC), an academic research organisation, the US National Cancer Institute (NCI), a governmental institution, the European Medicines Agency (EMA), a regulatory agency, and the American Association for Cancer Research (AACR), a professional scientific association, ensure that a unique programme focusing on multi-stakeholder approaches to cancer drug development will emerge. A rich scientific programme for IBCD 2015 has been developed covering topics of interest to all cancer drug development stakeholders. Registration open until 12/11/2015. ... Read more