EMA-raadpleging: ontwerprichtlijn over het gebruik van minimale resterende ziekte als klinisch eindpunt in onderzoeken naar multipel myeloom
The European Medicines Agency has released for public consultation a draft guideline on the use of minimal residual disease as a clinical endpoint in multiple myeloma studies.
The guideline aims to address the use of undetectable minimal residual disease (MRD) as an intermediate efficacy endpoint in controlled randomised clinical studies in patients with multiple myeloma (MM), adequately designed to demonstrate efficacy by relevant hard endpoints. MRD as an endpoint in this context would allow earlier approval of new drugs pending final confirmatory data.
The draft guideline is available by clicking here.
Comments should be provided using this template and sent to ONCWP@ema.europa.eu by 31st October 2018.
Please note that EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see Specific privacy statement for public consultations.
For more information on the European regulatory system for medicines, please click here (brochure available in all languages).