Horizon scanning: Phase II study of MEK162 for advanced melanoma harbouring NRAS or Val600 BRAF mutations
Source: Lancet Oncology
Area: News
An open-label, non-randomised, phase II study has reported positive data for MEK162 targeted therapy in patients with NRAS -mutated melanoma.
A total of 71 patients with NRAS-mutated (n=30) or BRAF-mutated (n=41) advanced melanoma enrolled at cancer centres in Europe and the USA were assigned to the following three arms:
. twice-daily MEK162 45 mg for NRAS-mutated melanoma,
. twice-daily MEK162 45 mg for BRAF-mutated melanoma,
. twice-daily MEK162 60 mg for BRAF-mutated melanoma.
The primary endpoint was the proportion...
Source: NeLM - News - February 13, 2013 Category: Drugs & Pharmacology Source Type: news
Horizon scanning: EU regulatory filing submitted for trametinib for metastatic melanoma
Source: BioSpace
Area: News
According to a BioSpace report, GlaxoSmithKline (GSK) has submitted a regulatory application to the European Medicines Agency (EMA) for trametinib as a monotherapy for BRAF V600 mutation-positive metastatic melanoma. The application is supported by data from a phase III study which evaluated the use of trametinib versus dacarbazine or paclitaxel monotherapy in BRAF V600 mutation positive metastatic melanoma patients (see NELM abstract below).
GSK is also looking to get trametinib in combination with dabrafenib, approved for use in adults with BRAF V600 mutation-positive metastatic m...
Source: NeLM - News - February 13, 2013 Category: Drugs & Pharmacology Source Type: news
CNS relapses in patients with HER2-positive early breast cancer who have and have not received adjuvant trastuzumab (BIG 1-01)
Source: Lancet Oncology
Area: News
Several randomised trials have confirmed the benefit of adjuvant trastuzumab for patients with HER2-positive early breast cancer but have identified CNS as the first site of relapse, possibly because trastuzumab does not adequately penetrate the CNS. To investigate further, researchers used data from the HERA trial to assess the frequency and course of CNS relapses, either as first event or at any time.
The HERA trial (BIG 1-01) is a large randomised phase 3 study comparing treatment with adjuvant trastuzumab after standard adjuvant chemotherapy for 1 year or 2 years with only...
Source: NeLM - News - February 13, 2013 Category: Drugs & Pharmacology Source Type: news
Cohort study: Association between maternal use of folic acid supplements and risk of autism in children
Source: JAMA
Area: News
It is well known that prenatal folic acid supplements reduce the risk of neural tube defects in children, but less is known about whether they protect against other childhood neurodevelopmental disorders such as autism spectrum disorders (ASDs; autistic disorder, Asperger syndrome, pervasive developmental disorder -not otherwise specified [PDD-NOS]).
To investigate, researchers followed a sample of 85,176 Norwegian children, derived from the population-based, prospective Norwegian Mother and Child Cohort Study (MoBa). The children were born in 2002-2008; by the end of follow-up on March ...
Source: NeLM - News - February 13, 2013 Category: Drugs & Pharmacology Source Type: news
RCT: Tedizolid phosphate vs linezolid for treatment of acute bacterial skin and skin structure infections (ESTABLISH-1)
Source: JAMA
Area: News
Tedizolid phosphate is a novel oral, once daily oxazolidinone currently in development for the treatment of acute bacterial skin and skin structure infections (ABSSSIs). The ESTABLISH-1 (Efficacy and Safety of 6-day Oral Tedizolid in Acute Bacterial Skin and Skin Structure Infections vs 10-day Oral Linezolid Therapy) study is a phase III non-inferiority study that compared tedizolid phosphate and linezolid (an oxazolidinone licensed for complicated skin and skin structure infections).
The double-blind study randomised 667 adult patients recruited from 81 study centres in North America, L...
Source: NeLM - News - February 13, 2013 Category: Drugs & Pharmacology Source Type: news
RCT: Clopidogrel with or without aspirin in patients taking oral anticoagulant therapy and undergoing percutaneous coronary intervention (WOEST)
Source: Lancet
Area: News
If percutaneous coronary intervention (PCI) is required in patients taking oral anticoagulants, double antiplatelet therapy with aspirin and clopidogrel is indicated. However, such triple therapy increases the risk of serious bleeding and this treatment strategy has not been tested prospectively.
Omission of oral anticoagulants could lead to an increased risk of thrombotic stroke, whereas clopidogrel is essential to prevent stent thrombosis. The exclusion of aspirin might, therefore, be useful to reduce the bleeding risk in patients with coronary artery disease.
The open-l...
Source: NeLM - News - February 13, 2013 Category: Drugs & Pharmacology Source Type: news
Horizon scanning: Lenalidomide on fast-track review by the USFDA for mantle cell lymphoma
Source: Reuters Health News
Area: News
According to a report by Reuters Health News, the US Food and Drug Administration (FDA) has granted priority review for lenalidomide used for the treatment of relapsed or refractory mantle cell lymphoma (Source: NeLM - News)
Source: NeLM - News - February 12, 2013 Category: Drugs & Pharmacology Source Type: news
Pharmaceutical industry to report spend on promotions to healthcare professionals
Source: E-Health Insider
Area: News
According to a report by E-Health Insider, pharmaceutical companies are starting to monitor and report the money they spend on promoting their products to healthcare professionals in the UK and Europe. The Ethical Standards in Health and Life Sciences Group, a group of 20 healthcare organisations including the British Medical Association and the Association of the British Pharmaceutical Industry, has launched a consultation on creating a register of payments made to healthcare professionals by commercial organisations.
The group's members believe that public disclosure of th...
Source: NeLM - News - February 12, 2013 Category: Drugs & Pharmacology Source Type: news
Case of novel coronavirus identified in the UK
Source: Health Protection Agency
Area: News
The Health Protection Agency (HPA) has issued a statement confirming the diagnosis of a further case of novel coronavirus infection in a UK resident who had recently travelled to the Middle East and Pakistan. The patient is currently receiving intensive care treatment in a Manchester hospital. This latest case brings the total number of confirmed cases in UK to 2. (Source: NeLM - News)
Source: NeLM - News - February 12, 2013 Category: Drugs & Pharmacology Source Type: news
JCO overview of advances in NSCLC
Source: Journal of Clinical Oncology
Area: News
The early online issue (11 February 2013) of the Journal of Clinical Oncology has featured several review articles on various aspects of the diagnosis and management of non-small cell lung cancer (NSCLC). Firstly, an overview describes how diagnosis and management of NSCLC has changed over the years, followed by separate review articles on the following:
. KRAS Mutation: Should We Test for It, and Does It Matter?
. Maintenance Chemotherapy for Advanced Non-Small-Cell Lung Cancer: New Life for an Old Idea
. New Pathologic Classification of Lun...
Source: NeLM - News - February 12, 2013 Category: Drugs & Pharmacology Source Type: news
IMI launches first antimicrobial resistance projects
Source: PharmaTimes
Area: News
The European Union's Innovative Medicines Initiative (IMI) has launched the first two projects under its research programme for antimicrobial resistance. The projects, launched under the New Drugs for Bad Bugs (ND4BB) programme are COMBACTE (Combating Bacterial Resistance in Europe) and TRANSLOCATION (Molecular basis of the bacterial cell wall permeability):
. The COMBACTE team plans to develop innovative trial designs that will facilitate the registration of novel antibacterial agents. It will also design and validate tests to support patient diagnoses, identify the most app...
Source: NeLM - News - February 12, 2013 Category: Drugs & Pharmacology Source Type: news
Response to consultation on proposals for commissioners to deliver best value published
Source: Department of Health (DH)
Area: News
The Department of Health's response to the consultation on proposals to protect patients' interests by ensuring commissioners operate within a framework of rules to secure the best clinical services for patients and deliver best value has been published.
Please see link for details. (Source: NeLM - News)
Source: NeLM - News - February 12, 2013 Category: Drugs & Pharmacology Source Type: news
DH website to move to GOV.UK in March 2013
Source: Department of Health (DH)
Area: News
The Department of Health website will move to the new single website for government in March 2013 - GOV.UK is the new single website for UK Government. In October 2012 it brought together government information and guidance from Directgov and Business Link into one place.
GOV.UK will also replace all UK central government department websites.
Please see link for details on the content of the website and searching features on the website. (Source: NeLM - News)
Source: NeLM - News - February 12, 2013 Category: Drugs & Pharmacology Source Type: news
Meta-analysis: Efficacy of cytisine for smoking cessation
Source: Thorax
Area: News
Thorax has featured a meta-analysis of studies evaluating cytisine for smoking cessation.
A recent study had shown that cytisine, a low-cost drug, is effective for smoking cessation. A number of earlier studies exist, and cytisine was previously used - however, this meta-analysis was undertaken to assess the efficacy of cytisine in smoking cessation and to assess whether there is sufficient evidence to warrant licensing cytisine or whether more work is needed.
After a search on the Cochrane Library, CINAHL, Embase, Medline and PsycINFO databases, 7 controlled trials were ide...
Source: NeLM - News - February 12, 2013 Category: Drugs & Pharmacology Source Type: news
Meta-analysis: Anti-diabetic medications and the risk of hepatocellular cancer
Source: American Journal of Gastroenterology
Area: News
According to a meta-analysis published early online in the American Journal of Gastroenterology, diabetes medications have varying impacts on the risk for hepatocellular cancer (HCC).
Several pre-clinical and observational studies have suggested that conventional diabetes medications may modify the risk of HCC. To better understand these associations, researchers performed a systematic review and meta-analysis of 10 studies reporting 22,650 cases of HCC in 334,307 patients with type 2 diabetes. There were five case-control studies, three cohort studies and...
Source: NeLM - News - February 12, 2013 Category: Drugs & Pharmacology Source Type: news
