Biomarkers and Personalized Medicine
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Biomarkers and Personalized Medicine
Sharing relevant articles on advancements in personalized medicine
Curated by Brian Shields
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New melanoma driver genes found in largest DNA sequencing study to date

New melanoma driver genes found in largest DNA sequencing study to date | Biomarkers and Personalized Medicine | Scoop.it
Yale Cancer Center geneticists, biochemists, and structural biologists have painted the most comprehensive picture yet of the molecular landscape of melanoma, a highly aggressive and often deadly skin (RT @Yale: Largest DNA sequencing study finds ...
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Roche Molecular Gains FDA Clearance for Its Companion Diagnostic Test for New Skin Cancer Drug

Roche Molecular Gains FDA Clearance for Its Companion Diagnostic Test for New Skin Cancer Drug | Biomarkers and Personalized Medicine | Scoop.it

Recently, the Food and Drug Administration (FDA) cleared two products for market, one of which may be of particular interest to anatomic pathologists. The first product is a therapeutic drug for the treatment of late-stage skin cancer. The second product is a companion clinical laboratory test that will be used to identify skin cancer patients most likely to benefit from this new drug.


This development is attracting attention by experts watching the molecular diagnostics marketplace. That’s because both products were developed by the same company on a tight timeline and this process is likely to be much studied by other pharma companies and genetic test developers.


The company that developed the new drug and its companion diagnostic test is Roche Holdings AG (OTCQX: RHHBY). In its press release about the FDA’s decisions, the company simultaneously announced market clearance of the drug Zelboraf (vemurafenib) and the approval of the companion diagnostic, the cobas 4800 BRAF V600 Mutation Test.


Zelboraf will only be used in the treatment of those patients with inoperable or metastatic melanoma who have tested positive for the BRAF V600E mutation as determined by an FDA-approved test, the release stated. Almost 50% of metastatic melanoma patients have the mutation.


In the press release, Hal Barron, M.D., FACC, Chief Medical Officer and Head, Global Product Development at Roche, stated that the approval “marks a major step forward in personalizing the treatment of metastatic melanoma.”

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Cancer Journal: Latest cancer research New approaches may prevent certain side effects in BRAF mutation-positive melanoma | ecancermedicalscience

"Findings from preclinical studies in a skin cancer model showed that next-generation BRAF inhibitors used alone, or first-generation BRAF inhibitors used in combination with an epidermal growth factor receptor inhibitor, may have the potential to prevent drug-induced skin lesions in BRAF mutation-positive patients treated for melanoma..."

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"Step change" Yervoy from BMS not cost effective for NICE: may need biomarker test

{SCRIP via BioPortfolio} NICE, the health technology appraisal institute for England and Wales, has recognised Bristol-Myers Squibb's Yervoy (ipilimumab) as a &...
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Update on AZD6244 (MEK) and MK-2206 (AKT) inhibition in RAS driven cancers | Pharma Strategy Blog

Update on AZD6244 (MEK) and MK-2206 (AKT) inhibition in RAS driven cancers | Pharma Strategy Blog | Biomarkers and Personalized Medicine | Scoop.it
Data has been awaited on the AstraZeneca and Merck collaboration with their MEK and AKT inhibitors.
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Beta-blocker drugs may improve survival time for melanoma patients

Beta-blocker drugs, commonly used to treat high blood pressure, may also play a major role in slowing the progression of certain serious cancers, based on a new study.
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Vemurafenib (Zelboraf®, PLX 4032) Melanoma: FDA Review & Approval - a knol by Krishan Maggon

Vemurafenib (Zelboraf®, PLX 4032) Melanoma: FDA Review & Approval - a knol by Krishan Maggon | Biomarkers and Personalized Medicine | Scoop.it
The FDA approved Zelboraf on 17 August 20111 for the treatment of late stage metastatic melanoma. EMA approval is expected...
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Roche Diagnostics to get indirect boon from new test - Indianapolis Business Journal

Roche Diagnostics to get indirect boon from new test - Indianapolis Business Journal | Biomarkers and Personalized Medicine | Scoop.it
Indianapolis Business JournalRoche Diagnostics to get indirect boon from new testIndianapolis Business JournalLast week's US approval of a new Roche drug-diagnostic combo for skin cancer won't by itself produce much revenue for its diagnostic...
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Will vemurafenib receive early approval for metastatic melanoma? « Pharma Strategy Blog

Will vemurafenib receive early approval for metastatic melanoma? « Pharma Strategy Blog | Biomarkers and Personalized Medicine | Scoop.it
Reuters are reporting that FDA approval for Roche's vemurafenib or Zelboraf in BRAF V600E metastatic melanoma is imminent.
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The role of PTEN in non-melanoma skin cancer | Pharma Strategy Blog

The role of PTEN in non-melanoma skin cancer | Pharma Strategy Blog | Biomarkers and Personalized Medicine | Scoop.it
Skin cancer is the most common type of cancer in the United States. The tumor suppressor PTEN has been found to play a key role in radiation damage repair.
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Oncology Biomarkers: New epigenetic biomarker test for melanoma?

Oncology Biomarkers: New epigenetic biomarker test for melanoma? | Biomarkers and Personalized Medicine | Scoop.it
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How Personalized Medicine is Changing Cancer Care – A First Hand View « The Age of Personalized Medicine Blog

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A New Treatment's Tantalizing Promise Brings Heartbreaking Ups and Downs - New York Times

A New Treatment's Tantalizing Promise Brings Heartbreaking Ups and Downs - New York Times | Biomarkers and Personalized Medicine | Scoop.it
This is a very sad story about the promise and challenges of attacking rare cancers through gene sequencing methods.
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ERK1 or ERK2 Vemurafenib for Melanoma cells. | Tyrosine Kinase Inhibitors

ERK1 or ERK2 Vemurafenib for Melanoma cells. | Tyrosine Kinase Inhibitors | Biomarkers and Personalized Medicine | Scoop.it

Overcoming the infamous apoptotic resistance of most cancers cells remains a beneficial challenge given dismal tactical of patients with metastatic most cancers PLX-4032 B-Raf inhibitor. However, recent clinical trials using a BRAF inhibitor revealed encouraging results for patients using advanced BRAF mutant showing melanoma, but drug resistance accompanied by recovery of phospho-ERK (perk) activity present challenges for this purpose approach. While ERK1 and ERK2 are similar in amino acid composition and are frequently not distinguished with clinical reports, the possibility they set distinct biological functions in melanoma is basically unexplored. Cutaneous squamous-cell carcinomas and keratoacanthomas are normal findings in patients treated with BRAF inhibitors.

The main agent to demonstrate an overall survival benefit was this CTLA-4 antibody, ipilimumab, illustrating the benefit of the immune process and immunomodulation in most cancers tumorigenesis. The second group of agents to show a survival benefit were that selective Crizotinib PF-2341066, vemurafenib and GSK2118436, in patients who are BRAF V600 mutation confident. Although the majority are mild and can end up managed with supportive procedure, some toxicities require special management strategies. We description up-to-date clinical development together with management guidelines for ipilimumab, as well as the BRAF and MEK inhibitors...

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Signalling Protein VEGF Helps Renew Stem Cells In Common Skin Cancer

Signalling Protein VEGF Helps Renew Stem Cells In Common Skin Cancer | Biomarkers and Personalized Medicine | Scoop.it
New research from Belgium, published in Nature this week, reveals that VEGF, a signalling protein that is known to regulate the formation of new blood vessels, has a dual role in helping...
 
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When is NICE is not so nice?

“Ipilimumab is not recommended for the treatment of advanced (unresectable or metastatic) malignant melanoma in people who have received prior therapy.
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Targeting PTEN may prevent skin cancer

Targeting PTEN may prevent skin cancer | Biomarkers and Personalized Medicine | Scoop.it
The tumor suppressor PTEN played key role in radiation damage repair. Skin cancer is the most common type of cancer in the United States.
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Roche files vismodegib for basal cell carcinoma with FDA

Roche files vismodegib for basal cell carcinoma with FDA | Biomarkers and Personalized Medicine | Scoop.it
Good news this morning as Roche announced that their Hedgehog (Hh) inhibitor licensed from Curis, GDC-0449 (now known as vismodegib), has been submitted to the FDA for the treatment of advanced basal cell carcinoma (BCC) in patients for whom...
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Plexxikon Announces FDA Approval of Zelboraf™ (vemurafenib) and Companion Diagnostic for the Treatment of Patients with BRAF Mutation-Positive Metastatic Melanoma

Plexxikon Announces FDA Approval of Zelboraf™ (vemurafenib).
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Zelboraf approved by the FDA in metastatic melanoma | Pharma Strategy Blog

Zelboraf approved by the FDA in metastatic melanoma | Pharma Strategy Blog | Biomarkers and Personalized Medicine | Scoop.it
Zelboraf is now approved by FDA for treatment of patients with melanoma whose tumors express a gene mutation called BRAF V600E.
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Melanoma – new discovery in fight against it | MedTube Tribune - Medical news on-line

Melanoma – new discovery in fight against it | MedTube Tribune - Medical news on-line | Biomarkers and Personalized Medicine | Scoop.it
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BRAF targeted therapy changes the treatment paradigm in melanoma : Article : Nature Reviews Clinical Oncology

BRAF targeted therapy changes the treatment paradigm in melanoma : Article : Nature Reviews Clinical Oncology | Biomarkers and Personalized Medicine | Scoop.it
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Targeting PTEN may prevent skin cancer

Targeting PTEN may prevent skin cancer | Biomarkers and Personalized Medicine | Scoop.it
The tumor suppressor PTEN played key role in radiation damage repair. Skin cancer is the most common type of cancer in the United States. (Targeting PTEN may prevent skin cancer: The tumor suppressor PTEN played key role in radiation damage repair.
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