EMA Updates Guideline for Anticancer Medicines - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

EMA Updates Guideline for Anticancer Medicines


ePT--the Electronic Newsletter of Pharmaceutical Technology

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.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here