Navigation Links
Indication of considerable added benefit of vemurafenib in advanced melanoma
Date:1/8/2013

The drug vemurafenib (trade name Zelboraf) has been approved since February 2012 for the treatment of advanced melanoma (cancer of the skin cells that produce the dark pigment, melanin). It 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). The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined the added benefit of the drug pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG). According to the findings, major advantages in terms of overall survival are accompanied by major potential harm in the form of side effects. Overall, there is an indication that vemurafenib offers considerable added benefit.

Vemurafenib in comparison with dacarbazine

The Federal Joint Committee (G-BA) has specified the drug dacarbazine as the appropriate comparator therapy. One study that compared vemurafenib directly with dacarbazine was available for the benefit assessment. This is a randomized and open-label study, i.e. patients were randomly assigned to one of the two treatment groups and both they and their doctors knew which of the two drugs was used in each case.

Longer survival means major added benefit

IQWiG always assesses a drug with a view to patient-relevant outcomes such as survival (mortality), symptoms and complications (morbidity) as well as quality of life. The study provides an indication that vemurafenib can prolong life. While half of the patients who received dacarbazine died after less than 10 months, in the vemurafenib group this was the case only after more than 13 months. The differing course of the two survival curves provides an indication of a major added benefit of vemurafenib.

Pain was the only outcome recorded in the study in relation to morbidity. There were, however, no statistically significant differences between the treatment groups - and hence also no indication of an added benefit of vemurafenib. As regards the quality of life (including physical and emotional well-being), there were no differences, so here, too, an added benefit is not proven.

Major potential harm in the form of side effects

Overall, the side effect profile of vemurafenib is less favourable than that of dacarbazine, because severe adverse events (according to the Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 3) and serious adverse events were more frequent in patients who received vemurafenib. The proportion of those who discontinued the treatment due to side effects was comparable in the treatment groups. All in all, IQWiG sees an indication of greater harm from vemurafenib and rates its extent as "major".

Potential for harm reduces the extent of the added benefit

In order to derive proof of benefit from a single study, it must meet special requirements. This particular study does not fulfil them. Therefore no conclusions with the highest probability (proof) are possible - for example, on added benefit; at most indications can be derived from the study.

In summary, there are positive and negative results of the same degree of certainty (indications). On the positive side, the greatest extent - namely "major" - is attained for overall survival. On the negative side, due to side effects, there is an indication of greater harm, and this is also of major extent. For this reason, the Institute downgrades the overall added benefit of vemurafenib relative to the appropriate comparator therapy with dacarbazine from "major" to "considerable".

G-BA decides on the extent of added benefit

The dossier assessment is part of the overall procedure for early benefit assessment conducted by the G-BA. After publication of the manufacturer's dossier and its assessment by IQWiG, the G-BA initiates a formal commenting procedure, which provides further information and can result in a change to the benefit assessment. The G-BA then decides on the extent of the added benefit, thus completing the early benefit assessment.


'/>"/>
Contact: Dr. Anna-Sabine Ernst
presse@iqwig.de
0049-221-356-850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

Related medicine news :

1. Antibody-coated stents: Indication of disadvantages
2. Abiraterone: Indication of considerable added benefit in certain patients
3. Considerable added benefit of ipilimumab in advanced melanoma
4. Marketing Xocolate International Corporation (MXI-Corp) Introduces Xe Healthy Energy Drink, A Rich And Delicious Antioxidant Beverage, Now Added to Xoçai™ Product Line
5. Capsiplex Plus Reviews for Improved Weight Loss Supplement Added to BestAppetiteSuppressantPills.com
6. UV-Aid Cold and Flu Prevention Added to List of Biomimicry Strategies on AskNature.Org
7. Healthy Chocolate Omega Squares, a Decedent Dark Chocolate Added to Marketing Xocolate International Corporation (MXI Corp) Product Lines
8. Rilpivirine for HIV: Added benefit for single agent proven
9. US Drug Watchdog Has Added Wright, Stryker, Biomet, and Zimmer To Their Initiative For All Metal Hip Implant Failures Victims & Offers Them The Names Of The Best Lawyers
10. CFO 911 Solutions' Charles K. Dargan II, CEO, and Reid Dabney, Managing Director Have Been Added to the Financial Entrepreneur Platform ("FEP") of Merriman Capital, Inc., a Wholly Owned Subsidiary of Merriman Holdings, Inc. (OTCQX: MERR)
11. Vandetanib in thyroid cancer: No proof of added benefit
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... October 13, 2017 , ... PurhealthRX , a leading ... Purzorb™ technology. Applying the Purzorb™process to full spectrum CBD oil will revolutionize the rapidly ... CBD form that can be easily incorporated into liquid products, while reducing costs to ...
(Date:10/13/2017)... ... October 13, 2017 , ... The Visiting Nurse Association (VNA) of ... collection of specialty vendors and unique items from across the nation, this holiday-themed event ... wellness services offered by the VNA. The boutique will be open Saturday, November ...
(Date:10/13/2017)... ... October 13, 2017 , ... Coveros, a ... has been awarded a contract by the Center for Medicare and Medicaid Services ... accelerate the enterprise use of Agile methodologies in a consistent and high value ...
(Date:10/12/2017)... ... 2017 , ... Planet Fitness, one of the largest and fastest growing franchisors ... a flagship location in Covington, LA at 401 N. U.S. Highway 190, in January ... Office Depot in the Holiday Square shopping center. Its location allows it to serve ...
(Date:10/12/2017)... ... October 12, 2017 , ... Information ... we intend to develop to enable prevention of a major side effect of ... loss, especially in pediatric patients. For cisplatin, hearing loss is FDA listed on-label ...
Breaking Medicine News(10 mins):
(Date:10/5/2017)... 2017  In response to the nationwide opioid ... Surgeons (AAOMS) released prescribing recommendations that urge ibuprofen ... as a first-line therapy to manage a patient,s ... Recognizing the value and importance of ... Prescribing: Acute and Postoperative Pain Management" stresses that ...
(Date:10/2/2017)... , Oct. 2, 2017  Eli Lilly and ... financial results for the third quarter of 2017 on ... conference call on that day with the investment community ... The conference call will begin at 9 ... can access a live webcast of the conference call ...
(Date:9/28/2017)... -- Cohen Veterans Bioscience and Early Signal Foundation announce ... home sensors for real-time monitoring of patients with trauma-related ... organization focused on disruptive health solutions for rare disorders ... to record and integrate behavioral, cognitive, physiological and contextual ... ...
Breaking Medicine Technology: