In March 2014 the European Medicines Agency (EMA) published a draft guidance considering the role of pathological Complete Response (pCR) as an endpoint in neoadjuvant breast cancer studies.
On May 13 and 14, 2014, the Cancer Drug Development Forum (CDDF), then named Biotherapy Development Association (BDA), met in London to debate the draft guidance. In addition to endpoints in neoadjuvant breast cancer, the meeting, attended by delegates from academia, industry and the regulatory authorities, also considered minimal residual disease (MRD) in chronic lymphocytic leukaemia (CLL) and other haematological malignancies. A draft EMA document on MRD as an endpoint in CLL is expected in July. Please find the meeting report here.
Download the programme of the “Minimal Residual Residual Disease” Workshop here.
To have access to the workshop presentations, please contact CDDF Headquarters at firstname.lastname@example.org