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Database Access - UNSW Library. 125514s014lbl. Press Announcements > FDA approves first cancer treatment for any solid tumor with a specific genetic feature. The U.S.

Press Announcements > FDA approves first cancer treatment for any solid tumor with a specific genetic feature

Food and Drug Administration today granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker). This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated. FDA leaps into precision medicine — with caveats. He many proponents of precision medicine have long promised a world where terms like “lung cancer” and “melanoma” are rendered quaint by the awesome power of genomics.

FDA leaps into precision medicine — with caveats

And the FDA, with its latest approval, just endorsed that vision of the future. The agency cleared Merck’s blockbuster cancer drug Keytruda to treat any solid tumor with one of two genetic abnormalities, marking the first time the FDA has granted such an agnostic approval. There are, of course, caveats — the mutations are rare, and Keytruda can be used only after a prior treatment has failed — but it’s a milestone approval nonetheless, and one that will be heartening to some forward-thinking biotech companies. Unlock this article and other benefits — from industry reports to real-time conversations with our reporters — by subscribing to STAT Plus today. Already a subscriber? A one-two punch for pancreatic cancer: ‘softening’ tumours before chemo. Australian scientists have uncovered a promising new approach to treating pancreatic cancer, by targeting the tissue around the tumour to make it ‘softer’ and more responsive to chemotherapy.

A one-two punch for pancreatic cancer: ‘softening’ tumours before chemo

The findings are published today in Science Translational Medicine. In the study, which was carried out in mice and in patient-derived samples, researchers primed pancreatic tumours with a three-day course of Fasudil – a drug that ‘slackens the ropes’ of surrounding tissue to make tumours softer, and also makes the blood vessels around tumours "leaky". They then treated with standard-of-care chemotherapy for pancreatic cancer. Remarkably, this sequential two-step approach doubled survival time and also impaired the spread of cancer to other tissues. Pancreatic cancer has a dismal five-year survival rate of just 7%, a figure that has scarcely changed in the last 40 years. Database Access - UNSW Library. Database Access - UNSW Library. Database Access - UNSW Library. 'So what if my results say I'm doing better? I'm still dying – just not right now' Public servant Amanda Richards* expected to be dead by last Christmas if she didn't have chemo to stop the aggressive metastatic cancer that had crept from her breast to her liver.

'So what if my results say I'm doing better? I'm still dying – just not right now'

And when the chemotherapy stopped working, her oncologist put her on the hormone tamoxifen, giving it a 30 per cent chance of success. This is a modal window. This modal can be closed by pressing the Escape key or activating the close button. The Repurposing Drugs in Oncology (ReDO) Project. EviQ Cancer Education Online. Innovation Tops Current Trends in the 2016 Oncology Drug Pipeline. Last year witnessed a new high in the number of US Food and Drug Administration (FDA) approvals of new pharmaceuticals, including new molecular entities (NMEs) and new Biologic License Applications (BLAs), amounting to a total of 45 NMEs and BLAs in all disease states compared with 41 approved in 2014 and much fewer (27) in 2013.1 Of these 45 NMEs and BLAs entering the market last year, 16 were novel therapies for cancer,2 providing patients new hope through novel treatment options and new mechanisms of action.

Innovation Tops Current Trends in the 2016 Oncology Drug Pipeline

New trends in oncology drug development are reflected in the increasing use of biotechnology in the development of anticancer drugs, including immunotherapies or monoclonal antibodies, adoptive-cell therapies, and new vaccines.3 Innovation continues to be a much sought-after quality by the FDA in its approval of new drugs to improve patient outcomes, which is reflected in the agency’s close work with the pharmaceutical industry. Companion Diagnostics for Targeted Cancer Drugs – Clinical and Regulatory Aspects.

Introduction The understanding of the molecular mechanisms of cancer has increased considerably within the last 10–20 years, which has resulted in the development of a number of new targeted drugs.

Companion Diagnostics for Targeted Cancer Drugs – Clinical and Regulatory Aspects

A large proportion of these drugs has been developed using the drug–diagnostic co-development model where the diagnostic test and the drug are developed in parallel (1, 2). The use of this model requires a thorough understanding of the underlying molecular pathology and the drug mechanisms of action, in order to link a certain molecular characteristic to the treatment outcome. The first attempt to use the drug–diagnostic co-development model was made when trastuzumab (Herceptin®, Roche/Genentech) and a immunohistochemistry (IHC) assay were developed for HER2 positive advanced breast cancer (3, 4).

The main purpose of developing a CDx assay in most oncology drug research programs is to have a test that can predict whether a patient is likely to benefit from the drug in question. Figure 1. 4527. Ascopubs. GetSharedSiteSession?rc=4&redirect= The next generation of cures and disease management appears likely to come from combinations of emerging technologies.


For example, applying synthetic biology design and CRISPR-based genome editing to immune cells raises the hope for a safe and effective class of T-cell-based cancer therapeutics. Likewise, advances in genomic sequencing, high-resolution imaging, and nanotechnology offer new prospects for early diagnosis. Dozens Of New Cancer Drugs Do Little To Improve Survival, Frustrating Patients. Marlene McCarthy’s breast cancer has grown relentlessly over the past seven years, spreading painfully through her bones and making it impossible to walk without a cane.

Dozens Of New Cancer Drugs Do Little To Improve Survival, Frustrating Patients

Although the 73-year-old knows there’s no cure for her disease, she wants researchers to do better. It’s been years, she said, since she has found a drug that has actually helped. McCarthy said she’s frustrated that the Food and Drug Administration is approving cancer drugs without proof that they cure patients or help them live longer. “That simply isn’t good enough,” said McCarthy, of Coventry, R.I. “I understand [why] that could be satisfactory for some people. Cancer in Australia 2017. Cancer in Australia 2017 presents the latest available information on national population screening programs, Medicare data, cancer incidence, hospitalisations, survival, prevalence, mortality and burden of disease.

Cancer in Australia 2017

Cancer is the leading cause of disease burden in Australia. For all cancers combined, the incidence rate increased from 383 per 100,000 persons in 1982 to 504 per 100,000 in 2008, before an expected decrease to 470 per 100,000 in 2017. During the same period, the mortality rate decreased from 209 per 100,000 in 1982 to 161 per 100,000 in 2017. Asco. Office of Medical Products and Tobacco > Oncology Center of Excellence.

About the Oncology Center of Excellence The FDA's Oncology Center of Excellence will leverage the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics, and devices (including diagnostics).

Office of Medical Products and Tobacco > Oncology Center of Excellence

This Center of Excellence will help expedite the development of oncology-related medical products and support an integrated approach in the medical oncology clinical evaluation of drugs, biologics, and devices for the treatment of cancer. Upcoming oncology meetings hosted by FDA and stakeholders What FDA Officials Are Saying About OCE Current Leadership Richard Pazdur, M.D.Director, Oncology Center of ExcellenceUnited States Food and Drug Administration. Differences in Australian and New Zealand medicines funding policies. Treatment Switching in Cancer Trials. Costs and concerns in cancer care. European Alliance for Personalised Medicine - POLICY PAPERS. Precision Medicine: Technology, Regulations and Challenges.

Gene Therapy Clinical Trials Worldwide. Irrecist. Improving the Search for Biomarkers of Early Cancer. Welcome to EDRN — EDRN Public Portal. Sridhara Ovarian Ca workshop Innovative Trial Designs 9 3 15. Mansfield Precision Medicine. Beaver What Can We Learn FINAL. Detecting cancer earlier. Exercise Therapies for Cancer. Download our ‘Exercise and Lifestyle Therapies’ brochure. The UNSW Lifestyle Clinic is a leader in clinical services, and research in exercise and lifestyle therapies for people with chronic disease. A primary focus of the clinic is to provide evidence-based treatments for people afflicted or recovering from cancer - including those affected by post-cancer fatigue (PCF). The clinic is unique in that it provides programs and services for both adults and children/adolescents affected by cancer. We treat people at different stages of their cancer experience, namely: A Snapshot of Nanotechnology.

What Is Nanotechnology? A nanometer is a billionth of a meter, and nanotechnology is the creation of materials, devices, and systems on this minuscule scale. This technology is being applied to almost every field imaginable, including electronics, magnetics, optics, information technology, materials development, and biomedicine. Because of their small size, nanoscale materials and devices can interact readily with biomolecules both on the surface of cells and inside them.

JCI - Anti–PD-1/PD-L1 therapy of human cancer: past, present, and future. The FDA recently approved two PD-1 mAbs to treat human cancers, one from Bristol-Myers Squibb (Opdivo, also known as nivolumab, MDX-1106, BMS-936558, and ONO-4538) and another from Merck (Keytruda, also known as pembrolizumab, lambrolizumab, and MK-3475) (40). Additionally, multiple mAbs to either PD-1 or PD-L1 are under active development in hundreds of clinical trials involving thousands of patients. Thus far, anti-PD therapy has generated significant clinical benefits by inducing regression of advanced and metastatic tumors and improving survival. More importantly, anti-PD therapy can have durable effects, tolerable toxicity, and is applicable to a broad spectrum of cancer types, especially in solid tumors. How Far We've Come: A Decade in Review. Fig 1. FDA cancer drug approvals by year (2014 is through October) Database Access - UNSW Library. Database Access - UNSW Library. Database Access - UNSW Library.

Database Access - UNSW Library. Database Access - UNSW Library. Database Access - UNSW Library. Npc current landscape value assessment frameworks final. New Frameworks to Assess Value of Cancer Care: Strengths and Limitations. Updating the American Society of Clinical Oncology Value Framework: Revisions and Reflections in Response to Comments Received. Screening for Pancreatic Adenocarcinoma Using Signals From Web Search Logs: Feasibility Study and Results.

Cancer Drugs Fund 2.0: A Missed Opportunity? Christopher McCabeAffiliated withDepartment of Emergency Medicine, University of Alberta Email author , Ash PaulAffiliated withLondon Borough of Wandsworth, Greg FellAffiliated withSheffield City Council, Mike PauldenAffiliated withDepartment of Emergency Medicine, University of Alberta 10.1007/s40273-016-0403-2 Copyright information 1 Introduction The UK National Health service (NHS), like most other developed health care systems, has struggled with how to address the financial challenge created by the steady stream of increasingly expensive cancer treatments receiving regulatory approval. In the first decade of this century, the UK National Institute for Health and Care Excellence (NICE) Technology Appraisal process was used to identify those that were likely to represent good value at the manufacturer’s asking price, to negotiate price discounts where possible, and to explain withholding of funding when negotiations failed. 2 CDF 2.0: What Has Been Proposed?

3 What is Wrong With CDF 2.0? Impact of precision medicine in refractory malignancies: A meta-analysis of 13,203 patients in phase I clinical trials. Abstract Disclosures. Reports. NCCN Imaging Appropriate Use Criteria Compendium. NCCN Guidelines® & Clinical Resources. Pharmacovigilance in oncology: evaluation of current practice and future perspectives - Baldo - 2014 - Journal of Evaluation in Clinical Practice.

Telecom giant Telstra to support Australia in building large cancer database - BioSpectrum Asia. ASCO%20Abstract%20Poster final 0. Database Access - UNSW Library. Database Access - UNSW Library. Collection on Cancer Immunotherapy - British Journal of Cancer. WISH - World Innovation Summit for Health. EviQ Cancer Treatments Online > eviQ home. Theconversation. The Pharmaceutical Benefits Scheme (PBS) spends over A$9 billion a year subsidising a wide range of drugs to ensure affordability for all Australians. But when it comes to rare cancers – such as bone and soft tissue tumours called sarcomas – the scheme falls short.

This happens for a number of reasons. The main one is that rarity means less value for money. But should our new understanding of how cancers develop and could be treated mean we should change the way the scheme registers cancer drugs? Diagnosing cancers Cancers used to be diagnosed by determining the organ, such as breast or lung, from which they came. Because there are more patients for common cancer trials, and a larger market if the drugs are effective, more drugs to treat these are being tested and therefore registered. The TGA refers to drugs used to treat rare diseases as orphan drugs and offers reduced application fees to register these. From location to tumour type. It's all relative: how to understand cancer risk. Cts. An implantable microdevice to perform high-throughput in vivo drug sensitivity testing in tumors.

Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Early Stage, HER2-Positive or Triple Negative Breast Cancer Receiving Neoadjuvant Therapy. Experimental: patients with early stage breast cancer Prior to systemic therapy, patients will have placement of 3 devices within the tumor unless limited by tumor size, where fewer may be placed. Abacavir Pharmacogenetics – From Initial Reports to Standard of Care. MMS: Error. STI571 (Gleevec™) as a paradigm for cancer therapy.

Fig. 1. Realising the Value of Linked Data to Health Economic Analyses of Cancer Care: A Case Study of Cancer 2015. PLOS Medicine: Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK): Explanation and Elaboration. Addressing Skyrocketing Cancer Drug Prices Comes With Tradeoffs:  Pick Your Poison. Blood 2013 03 490003. Database Access - UNSW Library. Leukaemia success heralds wave of gene-editing therapies. Sharon Lees/ Great Ormond Street Hospital Layla received gene-edited immune cells from a healthy donor. Layla, a one-year-old girl with leukaemia, is in remission thanks to gene-editing technology that allowed her to receive modified immune cells from another person. Her case represents the second trial of gene-editing as a therapy — the first was carried out last year in patients with HIV.

More similar trials are planned — and companies are also preparing to trial therapies that inject DNA that codes for gene-editing enzymes directly into the human body. Immunologist Waseem Qasim of Great Ormond Street Hospital for Children NHS Trust in London, whose team treated the girl, says that his team had planned to start a safety trial next year in 10–12 patients.

A bridge to a cure To administer the therapy, the researchers extract immune cells called T-cells from a healthy donor, and expose them to a type of DNA-cutting enzyme called a TALEN. Haemophilia hope. 22-23 September 2016, Australian Technology Park, Sydney. GetSharedSiteSession?rc=4&redirect= GetSharedSiteSession?redirect= 1 s2.0 S1470204515001643 main. EviQ Cancer Treatments Online > eviQ home. Colon Cancer with Dr. Howard Schecter : MD-VOD. Colon cancer: Essential facts. Bjc2015265a.pdf. UCM430299. IMS Health Finds Global Cancer Drug Spending Crossed $100 Billion Threshold in 2014. Contact:Tor ConstantinoIMS Five-Year Growth Averages 6.5 Percent; Higher Prevalence of Cancers, Earlier Treatments, Innovative Therapies, Improved Survival Rates Transform Clinical Landscape PARSIPPANY, NJ, May 5, 2015 – Earlier diagnosis, longer treatment duration and increased effectiveness of drug therapies are contributing to rising levels of spending on medicines for cancer care.

According to a new report released today by the IMS Institute for Healthcare Informatics, total global spending on oncology medicines – including therapeutic treatments and supportive care – reached the $100 billion threshold in 2014, even as the share of total medicine spending of oncologics increased only modestly. Targeted therapies have dramatically increased their share of the total global oncology spend, rising 14.6 percent CAGR during the past five years with steady increases across all regions. The report’s key findings include the following:

Cancer-chart-pack-5-22-14. BioMedTracker. ProQuest. ProQuest. ProQuest. ProQuest. Database Access - UNSW Library. Database Access - UNSW Library. Database Access - UNSW Library. Poly(ADP-ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer - Cochrane Database of Systematic Reviews - Wiggans. The Drug Development Process. How prescription drugs are developed. Dominic Barnes, Vice President, Medical and Scientific Affairs, Janssen-Cilag Australia, and part-time General Practitioner, Sydney Summary Modern drug development is a risky business both for pharmaceutical companies and patients. Many thousands of promising compounds need to be tested. Following discovery of a promising compound, extensive animal and human trials are undertaken in consultation with government regulators under strict ethical conditions to provide evidence that the new drug works, is safe and is manufactured using the highest quality standards. This evidence is evaluated by the regulatory authorities and, if acceptable, leads to the registration of the new medicine.

Key words: clinical trials, drug evaluation, drug industry. Database Access - UNSW Library. Database Access - UNSW Library. Database Access - UNSW Library. Sign In. Ucm444660.