The European Medicines Agency supports World Cancer Day, which is taking place on Monday 4 February 2013. World Cancer Day is held each year on 4 February to raise awareness about cancer and to encourage its prevention, detection and treatment. The day is led by the Union for International Cancer Control (UICC).
The Agency plays a key role in the authorisation of medicines to treat cancer. In the European Union (EU), all new anticancer medicines must be authorised centrally at a European level on the recommendation of the Agency, rather than in each Member State separately. To date, the European Commission has authorised over 100 medicines for the treatment or prevention of cancer or its symptoms on the recommendation of the Agency’s Committee for Medicinal Products for Human Use (CHMP). In the area of paediatric oncology, since 2007, the Agency’s Paediatric Committee (PDCO) has agreed on paediatric investigation plans as part of the development of 43 anticancer medicines. Some of these medicines display an innovative mechanism of action.
The Agency publishes scientific guidelines recommending how companies should study the safety and efficacy of anticancer medicines. In January 2013, the Agency published a revision of its guideline on the evaluation of anticancer medicinal products. The guideline provides guidance on all stages of clinical medicine development for the treatment of cancer. This revision includes, amongst other topics, the use of targets related to the mechanism of action of the drug (biomarkers) as an integrated part of the development of medicines, combination-therapy studies and the choice of endpoints in confirmatory trials. In May 2012, the Agency also organised a workshop on health-related quality of life in oncology (HRQoL) which aimed to bring together relevant experts and discuss HRQoL issues with a focus on available instruments and their utilisation in oncology clinical trials.
Bringing together oncology experts
The CHMP has two groups comprised of European cancer experts:
- a scientific advisory group (SAG) on oncology. SAGs are composed of independent experts, mainly from academia, selected by the CHMP according to their specific expertise. Patient representatives have also been appointed for specific meetings. This SAG has frequently provided advice during the scientific assessment of oncology drugs;
- an Oncology Working Party composed of European experts selected from or associated with the national agencies with specific expertise in oncology. The Working Party’s work includes a number of tasks that follow specific CHMP requests and are conducted under the CHMP’s supervision. The main activity of the Oncology Working Party has been the revision of the guideline on the evaluation of anticancer medicinal products.
Working closely with stakeholders
The Agency works closely with organisations representing patients with cancer, including the European Cancer Patient Coalition (ECPC), a group committed to improving the prevention, screening, early diagnosis and best treatment of cancer, reducing disparity and inequality across the EU, as well as the European Prostate Cancer Coalition (EUomo), Myeloma Patients Europe (MPE) and the International Confederation of Childhood Cancer Parent Organizations (ICCCPO).
The Agency also works closely with organisations representing healthcare professionals in the cancer field, including the European Society for Medical Oncology (ESMO), the leading European professional organisation committed to advancing the specialty of medical oncology and promoting a multidisciplinary approach to cancer treatment and care.
Within the field of paediatric oncology, the Agency also works together with international academic networks and the European Network for Cancer Research in Children and Adolescents (ENCCA), funded by the European Commission.