The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for nintedanib, in combination with docetaxel, for the treatment of patients with advanced non-small cell lung cancer (NSCLC) of adenocarcinoma histology after frst line chemotherapy.
The CHMP’s positive opinion has now been passed to the European Commission (EC), which grants marketing authorisation for medicines in the European Union. If approved, nintedanib will be the frst triple angiokinase inhibitor licensed for the treatment of second-line adenocarcinoma of the lung. Nintedanib is an investigational agent and not currently licensed in the UK.
The CHMP positive opinion is based on the international, randomised, double-blind, placebo-controlled, Phase III LUME-Lung 1 trial which compared nintedanib plus docetaxel to placebo plus docetaxel in patients with locally advanced/metastatic or recurrent NSCLC after failure of frst-line therapy.
In the trial, the median overall survival broke the one year barrier in patients of adenocarcinoma histology treated with nintedanib plus docetaxel (12.6 months for nintedanib plus docetaxel vs. 10.3 months for placebo plus docetaxel; p=0.0359).
The data also demonstrated that adenocarcinoma patients who progressed within nine months of the start of frst-line chemotherapy achieved a median overall survival beneft of three months (10.9 vs 7.9 months respectively; p=0.0073) with the addition of nintedanib to docetaxel.
Spiriva respimat becomes only lama licensed in asthma care
Adults with asthma could beneft from a new treatment following the decision to licence the once-daily inhaled corticosteroid (ICS) tiotropium (Spiriva) in the UK.
Spiriva Respimat has been granted this new indication based on the PrimoTinAasthma Phase III studies in adults with asthma who continue to have symptoms despite best-practice management with at least ICS + LABA.
The studies showed that compared to the addition of placebo to usual care, the addition of Spiriva Respimat to current treatment:
- reduced the number of patients who had a severe asthma exacerbation (26.9% versus 32.8%)
- reduced the risk of experiencing a severe exacerbation by more than one fifth (21%)
- delayed the time to first episode of asthma worsening (315 days versus 181 days).
The overall incidence of adverse events was comparable between patients in the Spiriva Respimat and placebo groups. The most commonly reported adverse events in both groups were asthma events, decreased rate of peak expiratory flow and common cold.
New data validates use of Tresiba insulin for children with Type 1 diabetes
Long-term glycaemic control in children and adolescents with type 1 diabetes could be improved with combined bolus insulin aspart (NovoLog) and insulin degludec (Tresiba), new study data has revealed.
In the 26-week BEGIN Young 1 trial, patients aged between one and 18 years with type 1 diabetes were randomised to receive once-daily insulin degludec or once- or twice-daily insulin detemir (Levemir) in combination with NovoLog. At the conclusion of the study, insulin degludec met its primary endpoint of noninferiority to Levemir on mean change in HbA1c.
Additionally, patients who received insulin degludec achieved “a lower insulin dose and a signifcantly greater reduction in fasting plasma glucose” compared to insulin detemir in the trial’s 26-week extension phase. Those taking insulin degludec also had signifcantly lower rates of hyperglycaemia with ketosis, though weight increased with degludec while remaining unchanged with insulin detemir.
Insulin degludec is a once-daily basal insulin with a duration of action beyond 42 hours. The drug has received regulatory approval in Europe, Argentina, Brazil, Hong Kong, Iceland and several other countries, though the FDA has not approved it.
The data was presented by Novo Nordisk at the 50th Annual Meeting of the European Association of the Study of Diabetes.
New once-daily dual bronchodilator treatment for COPD available in the UK
The European Commission has approved the use of Anoro (umeclidinium/vilanterol) for use in the treatment of chronic obstructive pulmonary disorder (COPD) in the UK.
Anoro is a bronchodilator treatment that relieves the symptoms in adult patients suffering with COPD. It is a combination of two bronchodilators used in a single dry powder inhaler, the Ellipta. It contains umeclidinium (UMEC), a longacting muscarinic antagonist (LAMA) and vilanterol (VI), a long-acting beta agonist (LABA). LAMAs and LABAs relax the airwaves to improve airfow into and out of the lungs.
The approval follows a phase III trial programme that included seven clinical studies and more than 6,000 patients suffering with COPD.
UMEC/VI has had a phased introduction into the healthcare system to allow specialists and local formularies to access the new treatment.
For the EU summary of product characteristics for Anoro, visit: http:// ec.europa.eu/health/documents/ community-register/index_en.htm.
Update: Incruse (umeclidinium) Ellipta has been approved for use in the UK. Umeclidinium is a once-daily long acting muscarinic antagonist (LAMA), and is the third treatment to be approved for the Ellipta inhaler this year. Its approval follows trials on 1,663 patients, who received doses of 55 micrograms or greater for a period of one year.
EMA give ovarian cancer drug green light
The European Medicines Agency (EMA) has recommended olaparib for approval for women with ovarian cancer who have a BRCA gene mutation.
The recommendation for the drug, produced by AstraZeneca, follows a negative ruling by a US panel in June, which voted against the drug’s accelerated approval. It’s the frst time a cancer drug will have been approved that targets an inherited genetic fault.
Olaparib blocks an enzyme involved in cell repair and is designed for patients with certain hereditary gene mutations. It also has promise in treating other cancers, opening up a substantial market opportunity.
Professor Alan Ashworth from the Institute of Cancer Research (ICR), whose work underpinned the development of olaparib, said: “The European Medicines Agency’s recommendation that olaparib be approved for some patients with ovarian cancer marks an important moment in the development of targeted treatments for cancer.
“It is a great example of how collaboration can take scientifc principles and turn them into treatments – showing how close interaction between researchers here at the ICR, a UK biotech and drug company, NHS hospitals and charitable funding bodies can improve the outlook for cancer patients worldwide.
“This ruling by the EMA marks the frst time a cancer drug targeted at an inherited genetic fault will have been approved. It should be a signifcant step in expanding the treatment options available for patients with tumours caused by inherited BRCA mutations.”
The news follows a similar announcement regarding the use of the drug afatinib, which has been used to tackle womb cancer.
Afatinib, a type of personalised medicine, attacks faults in the HER2 gene which lie at the heart of the cancer cells. Drugs which target HER2 are already used to treat breast cancer. It is currently being tested in clinical trials for a number of cancers including bowel cancer and certain types of lung and breast cancer.
New guide published for gastrointestinal intolerance in adults
A new resource has been launched to help healthcare professionals identify, assess and manage the symptoms of gastrointestinal intolerance (GI) in malnourished adults.
The guide, by Abbott Nutrition, provides support for multi-disciplinary teams working in disadvantaged communities.
When symptoms suggestive of GI intolerance occur, prompt management is essential to prevent dehydration, weight loss and exacerbation of malnutrition, according to the guide. Effective symptom management improves patient quality of life and can help prevent hospital admissions and reduce the high economic burden already posed by malnutrition. But recognising the symptoms of GI intolerance, understanding possible causes and deciding on the best management strategy can be a challenge.
Kelly McCabe, head of dietetics and therapies at the London Oncology Centre and chair of the expert group that developed the guide, said: “GI intolerance affects a large and diverse group of people in the community. It can have a considerable impact on patient quality of life, yet is often under-recognised and under-diagnosed. There is a real need for practical guidance in this area.”
GI intolerance arises as a result of maldigestion and/or malabsorption of food and may be caused by clinical factors such as coeliac disease, enzyme defciency or GI surgery; or medicines including antibiotics and laxatives. The main symptoms include diarrhoea, steatorrhoea, bloating and abdominal discomfort.
A recent survey among dieticians indicated that less than 20% of respondents would consider themselves to be very confdent in managing all of the symptoms of GI intolerance. In addition, more than three quarters (78%) of survey respondents felt that more guidance is needed to support healthcare professionals dealing with patients experiencing symptoms of GI intolerance in the community.
The consensus guide takes a symptombased approach that can be used across all patient groups, regardless of the cause of GI intolerance. It brings all of the information together in a concise format that is easy to use on a day-to-day basis and seeks to highlight red fag symptoms that require further specialist referral.
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