Featured Research

from universities, journals, and other organizations

Vemurafenib: Result unchanged despite new data

Date:
December 18, 2013
Source:
Institute for Quality and Efficiency in Health Care
Summary:
The manufacturer's second dossier on the drug Vemurafenib contained additional and more recent data, but did not provide any new findings. Hence the result "indication of considerable added benefit" remains unchanged.

Pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) reassessed vemurafenib (trade name: Zelboraf), a drug for the treatment of adults with a certain type of advanced melanoma. The reason for this was that the Federal Joint Committee (G-BA) had limited its decision on the first assessment to one year. This obliged the drug manufacturer to submit a second dossier.

This dossier contained additional and more recent data, but did not provide any new findings. IQWiG therefore still considers there to be an indication of a considerable added benefit of vemurafenib.

Longer survival, but also major side effects

The drug approved since February 2012 can be an option for adults whose melanoma cannot be removed by surgery or has formed secondaries (metastases) and in whose cancer a change (mutation) has occurred in a certain gene (BRAF-V600). G-BA had specified the drug dacarbazine as the appropriate comparator therapy.

In its first AMNOG assessment in June 2012, the Institute concluded that vemurafenib had major advantages in overall survival, but also major disadvantages in the form of side effects. Overall, this resulted in an indication of a considerable added benefit.

Treatments mixed during the course of the study

The manufacturer used the approval study again in its second dossier, and presented additional results from later analysis dates (data cut-offs). However, because of the special design of this study, the risk of bias of the results increased with each data cut-off.

In the first year of the study, patients in whom the disease progressed could be treated with further anti-cancer treatments. They could not switch from dacarbazine to vemurafenib, however. The analysis after this first year was therefore informative for the comparison of vemurafenib and dacarbazine. After this analysis, it was possible to switch from dacarbazine to vemurafenib, which made the results for the comparison of the two treatment options increasingly uncertain. This is the reason why IQWiG did not draw any new conclusions from the later analyses now provided.

Historical comparison is unsuitable

In the second dossier, the manufacturer also added a so-called "historical comparison": Firstly, it compared the survival rates under dacarbazine from other studies with the survival rates under dacarbazine from the approval study. It then related the results of this comparison to the survival rates of vemurafenib (approval study). With regards to the added benefit of vemurafenib, this did not result in any new findings beyond the ones from the approval study. At the most, the historical comparison allows the conclusion that patients in the approval study possibly had a better prognosis than patients in older studies.

Hence the new manufacturer dossier did not contain any new data that would be suitable for describing the added benefit of vemurafenib. Hence the result of the first assessment remains valid.


Story Source:

The above story is based on materials provided by Institute for Quality and Efficiency in Health Care. Note: Materials may be edited for content and length.


Cite This Page:

Institute for Quality and Efficiency in Health Care. "Vemurafenib: Result unchanged despite new data." ScienceDaily. ScienceDaily, 18 December 2013. <www.sciencedaily.com/releases/2013/12/131218112954.htm>.
Institute for Quality and Efficiency in Health Care. (2013, December 18). Vemurafenib: Result unchanged despite new data. ScienceDaily. Retrieved September 2, 2014 from www.sciencedaily.com/releases/2013/12/131218112954.htm
Institute for Quality and Efficiency in Health Care. "Vemurafenib: Result unchanged despite new data." ScienceDaily. www.sciencedaily.com/releases/2013/12/131218112954.htm (accessed September 2, 2014).

Share This




More Health & Medicine News

Tuesday, September 2, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Get on Your Bike! London Cycling Popularity Soars Despite Danger

Get on Your Bike! London Cycling Popularity Soars Despite Danger

AFP (Sep. 1, 2014) Wedged between buses, lorries and cars, cycling in London isn't for the faint hearted. Nevertheless the number of people choosing to bike in the British capital has doubled over the past 15 years. Duration: 02:27 Video provided by AFP
Powered by NewsLook.com
Can You Train Your Brain To Eat Healthy?

Can You Train Your Brain To Eat Healthy?

Newsy (Sep. 1, 2014) New research says if you condition yourself to eat healthy foods, eventually you'll crave them instead of junk food. Video provided by Newsy
Powered by NewsLook.com
We've Got Mites Living In Our Faces And So Do You

We've Got Mites Living In Our Faces And So Do You

Newsy (Aug. 30, 2014) A new study suggests 100 percent of adult humans (those over 18 years of age) have Demodex mites living in their faces. Video provided by Newsy
Powered by NewsLook.com
Liberia Continues Fight Against Ebola

Liberia Continues Fight Against Ebola

AFP (Aug. 30, 2014) Authorities in Liberia try to stem the spread of the Ebola epidemic by raising awareness and setting up sanitation units for people to wash their hands. Duration: 00:41 Video provided by AFP
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins