Melanoma Drug, Vemurafenib, Approved By US FDA

Posted by taznetwork at 1:33 AM . Monday, August 22, 2011

Editor's Choice
Main Category: Melanoma / Skin Cancer
Also Included In: Dermatology; Cancer / Oncology
Article Date: 20 Aug 2011 - 1:00 PDT window.fbAsyncInit = function() { FB.init({ appId: 'aa16a4bf93f23f07eb33109d5f1134d3', status: true, cookie: true, xfbml: true, channelUrl: 'http://www.medicalnewstoday.com/scripts/facebooklike.html'}); }; (function() { var e = document.createElement('script'); e.async = true; e.src = document.location.protocol + '//connect.facebook.net/en_US/all.js'; document.getElementById('fb-root').appendChild(e); }()); email to a friend printer friendly opinions
4 stars not yet rated
The drug vemurafenib (Zelboraf) for metastatic melanoma in patients who test positive for the BRAF mutation, has been approved by the U.S. Food and Drug Administration. Vemurafenib, a BRAF-inhibitor, is a personalized investigational drug designed to specifically inhibit the activity of the mutant BRAF protein that is present in almost half of all melanoma cases, the most lethal and aggressive form of skin cancer.

Jeffrey Weber, M.D., Ph.D., director of the Donald A. Adam Comprehensive Melanoma Research Center at Moffitt said:

"This is a great success story. To find a mutation and develop a test to enable widespread testing and matching a patient to the treatment is just the kind of personalized medicine we want to be known for here at the cancer center."

Weber was a researcher on the trial that administered BRIM2, a global, single-arm, multicenter, open-label Phase II investigation involving 132 patients with previously treated BRAF V600 mutation-positive metastatic melanoma. The primary endpoint of the investigation was overall response rate as evaluated by an independent review committee. Trial administrators reported that in 52% of trial participants, vemurafenib shrank tumors, they also spent a median of 6.2 months without their disease getting worse (median PFS).

Cutaneous squamous cell carcinoma, a common skin cancer treated by local excision (minor surgery done in a physician's office), was the most frequent Grade 3 adverse event. The most common adverse events were rash, increased sun sensitivity, joint pain, hair loss and fatigue. Potential serious side effects of vemurafenib include liver problems, changes in heartbeat or very fast or abnormal heartbeats, and allergic reactions.

Written by Grace Rattue
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional. For more information, please read our terms and conditions.

Please note that we publish your name, but we do not publish your email address. It is only used to let you know when your message is published. We do not use it for any other purpose. Please see our privacy policy for more information.

If you write about specific medications or operations, please do not name health care professionals by name.

All opinions are moderated before being included (to stop spam)

Contact Our News Editors

For any corrections of factual information, or to contact the editors please use our feedback form.

Please send any medical news or health news press releases to:

View the original article here

FREE