The European Medicines Agency has revised its guideline for the evaluation of anticancer medicinal products.
The European Medicines Agency has revised its guideline for the evaluation of anticancer medicinal products. The guideline offers guidance on all stages of clinical drug development for anticancer medicines and covers the use of biomarkers, combination therapy studies and the choice of endpoints in confirmatory trials.
According to EMA, a large number of anticancer compounds have been developed but very few have successfully obtained a marketing authorisation because of poor activity or inappropriate safety profiles. “Until non-clinical models with good predictive properties have been defined, this situation is likely to remain essentially unchanged,” explained the guideline, “and the absence of such models is considered the greatest hurdle for efficient drug development within the forseeable future.
Among other topics, the guideline highlights how biomarkers can help identify the target population that is most likely to benefit from the proposed compound. In addition, the guideline focuses on the importance of confirmatory trials that demonstrate a product’s clinical benefits.
Guidance is also provided for combination studies, such as combinations of drugs with minimal activity as a monotherapy, but synergistic effects when combined, as well as combinations of conventional cytotoxics.
The guideline will come into effect on 1 July 2013.
EMA’s guideline on anticancer medicinal products was first adopted in 1996, and was revised in 2001, 2003 and 2005.
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
INTERPHEX 2025: Use of Walk-In Chambers for Bio/Pharma Development and Manufacturing
April 2nd 2025Sitting down with the PharmTech Group at INTERPHEX 2025, Christopher Murphy, director of Global Business Development and Service Customer Support at Environmental Specialties, discusses the design and critical role of walk-in chambers in the bio/pharmaceutical industry.
Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain
November 14th 2023In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.