Friday, September 18, 2015

Zelboraf Clinical Trial Results

Viralytics Clinical Update
BRAF inhibitor Zelboraf. Exhibit 1 summarises the clinical trial results of CAVATAK and T-vec. While we acknowledge that comparisons between different clinical trials can potentially be misleading, we note that Exhibit 1 ... Retrieve Document

Vemurafenib - Nature.com
In August 2011 vemurafenib (Zelboraf; Daiichi Sankyo/Roche), based on a trial showing that it could improve survival 2. Highly promising results have also been obtained in clinical trials of small-molecule inhibitors of the cytoplasmic serine/threonine kinase BRAF, ... Fetch Doc

OTC: LBIO
Second Phase II Clinical Trial at NCI results for TILs with Zelboraf (NCI) Phase I data on IPI combination trial (Moffitt) $2 M $4 M $7 M $10 M Cumulative Burn Complete license for next-Gen T cells TIL Combination Trials Next Generation TILs ... Get Doc

Drugs, Diagnostic Tests Approved Quickly
With a clinical trial already open, can be smaller and the trial may yield conclusive results sooner. For example, it took 9 years for vemurafenib (Zelboraf; Genentech) and more than 10 years for brentux-imab (Adcetris; Seattle Genetics), ... Access Document

Biomarkers In Systemic Autoimmune Diseases - Ppdi.com
Opportunity to advance clinical trial design and to change clinical practice. The with a BRAF inhibitor (vemurafenib [Zelboraf [4]]).The BRAF protein, in the RAS-RAF impressive results for melanoma patients. This scenario is clearly ideal. However, ... Retrieve Document

The European Medicines Agency Review Of Vemurafenib ...
The European Medicines Agency review of vemurafenib (Zelboraf ) Results from a phase 3 trial (N = 675) comparing vemurafenib 960 mg twice daily (taken either withorwithoutfood) Non-clinical aspects and clinical pharmacology ... Access Doc

Dr. Caroline Robert Discusses The MEK Inhibitor Trametinib ...
Caroline Robert, MD, PhD, Head of Dermatology at the Institute Gustave Roussy in Paris, France, discusses results from the METRIC trial, which examined the o ... View Video

LONDON CANCER NEWS DRUGS GROUP RAPID REVIEW Vemurafenib For ...
Vemurafenib for BRAF V600 mutation-positive metastatic malignant melanoma in the second and subsequent line setting April 2012 The main results were as follows: entered a clinical trial or 2) ... Doc Viewer

US Approves New Drug Against Skin Cancer - Medical Xpress
US approves new drug against skin cancer 17 August 2011, by Kerry Sheridan Zelboraf was given the nod by the US Food and Drug Administration more than two months early, after a global clinical trial showed it could work better than chemotherapy by targeting a gene ... Access Doc

Section Original Policy Date Last Review Status/Date Issue
Trials in melanoma patients. Vemurafenib (trade name Zelboraf®, also known as PLX4032 and RO5185426) The Phase III clinical trial selected all patients with a V600BRAF mutation using the FDA- the results of the trial refer primarily to patients with the BRAF mutation. ... Return Document

GSK Prices Tafinlar At $7,600/month, Undercutting Roche’s ...
GSK Prices Tafinlar At $7,600/month, Undercutting Roche’s Zelboraf :: “The Pink Sheet” :: Elsevier Business Intelligence reps are well trained and ... Document Retrieval

Complexities In Personalized Medicine: Harmonizing Companion ...
Complexities in Personalized Medicine: Harmonizing Companion Diagnostics • Clinical validation of the device is supported by the results of the drug trial when used to test specimens and identify patients eligible cohort with IUO assays run on clinical trial platforms ... Retrieve Document

Crizotinib - Wikipedia, The Free Encyclopedia
Which results in constitutive kinase activity that contributes to carcinogenesis and Clinical trials. Crizotinib caused tumors to shrink or stabilize in 90% of 82 patients Additionally, a phase 2 trial, PROFILE 1005, studies patients meeting similar criteria who have received ... Read Article

Companion Tests - S3.amazonaws.com
Zelboraf was co-developed in clinical trials with a diagnostic test to identify patients with a positive mutation in the results are to be used for diagnostic purposes / patient management, or are to be submitted to Health Canada in support of a clinical trial application or drug ... Fetch Document

BRAF (gene) - Wikipedia, The Free Encyclopedia
[14] [36] Vemurafenib (RG7204 or PLX4032) was licensed by the US Food and Drug Administration as Zelboraf for the treatment of metastatic melanoma in August 2011 based on Phase III clinical data. Improved survival was seen, [37] clinical trials, ... Read Article

Cancer Treatment Reviews
However recent results from a phase II clinical trial also showed that the median duration of response was 6.7 months and median progression Vemurafenib (Zelboraf , F. Hoffman-La Roche Ltd.) has recently been approved as monotherapy for BRAF V600E mutation-positive ... Fetch Content

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE
Page 1 of 286 NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE Vemurafenib for the treatment of locally advanced or metastatic BRAF V600 mutation ... Visit Document

Ponatinib - Wikipedia, The Free Encyclopedia
Ponatinib (trade name based on results of the PACE phase II trial reported days earlier at the annual The United States Food and Drug Administration issued a partial clinical hold on new trial enrollment for Iclusig on 9 October 2013 due to an increased number of blood clots observed ... Read Article

BRAF Gene Mutation Testing To Select Melanoma Patients
The Phase 3 clinical trial of vemurafenib selected all patients with a BRAF V600 mutation using the FDA-approved test. Therefore, results of the trial refer primarily to patients with the BRAF V600E mutation. Efficacy of ... Read Document

Helping You And Your Patients Understand The Possible Adverse ...
Always use your clinical judgment when prescribing ZELBORAF, and when monitoring and managing the associated AEs of treatment. You are encouraged to report side effects to Genentech and the FDA. ... Document Retrieval

Low Incidence Of Minor BRAF V600 Mutation-Positive Subclones ...
Determined by Sensitive and Quantitative Real-Time PCR Thomas Kristensen, A phase 3 randomized clinical trial of vemur-afenib (Zelboraf), results from the MRC FOCUS trial. J Clin Oncol 2009, 27:5931e5937 3. Chapman PB, ... Read Full Source

OVERVIEW•Catalyst PRODUCT OVERVIEW•Key Marketed And Pipeline ...
•Table: Overview of pivotal trial data for Zelboraf in melanoma, 2012 Summary of Phase II clinical trial data for trametinib in melanoma Phase III results for first-line dabrafenib in metastatic melanoma ... Fetch Full Source

BRAF Gene Mutation Testing To Select Melanoma Patients For ...
The Phase 3 clinical trial of vemurafenib selected all patients with a BRAFV600 mutation using the FDA-approved Therefore, results of the trial refer primarily to patients with the BRAFV600E mutation. Efficacy of vemurafenib for patients with other mutations, including BRAFV600K, is less ... Visit Document

BRAF Mutation Analysis (V600E)
Clinical Use: The BRAF V600E the predominant mutation in this codon is V600E (GTG to GAG). Recent clinical trial data show promising results following treatment of melanoma with the BRAF V600E [ZELBORAF(R)]; Plexxikon/Roche Pharmaceuticals). Eighty-one percent of patients harboring the ... Fetch Document


Learn more about interferon-alfa2b, In the second trial, Many other clinical trials have been conducted (and are still being conducted) in an attempt to increase the effectiveness of IFN. Unfortunately, ... Read Article

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