Onco Actu du 31 août 2018

	1. Biologie
Children’s bone cancers could remain hidden for years before diagnosis [Wellcome Sanger Institute] Complex genetic rearrangements found in many Ewing sarcomas could help inform diagnosis and treatment.
	2. Etiologie
Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on FDA’s ongoing investigation into valsartan impurities and recalls and an update on FDA’s current findings [FDA] We have closely coordinated with the European Medicines Agency, European Directorate for the Quality of Medicines, Regulatory Operations and Regions Branch and Therapeutic Products Directorate of Health Canada, and the Pharmaceuticals and Medical Devices Agency in Japan since that time, sharing information about our investigation with them and other regulatory bodies and learning about their findings
FDA widening probe into heart drugs linked to cancer risk [STAT] The agency estimated that if 8,000 people took the highest valsartan dose of 320 mg in a pill containing NDMA daily for four years — which is the amount of time the FDA believes the affected pill had been on the U.S. market — there may be one additional case of cancer over their lifetimes beyond the average cancer rate among Americans.
	4.12 Biopsies liquides
A Model Based on Serial Liquid Biopsy Sampling May Predict Time to Progression in Patients With Colorectal Cancer [AACR] Limitations of the study include a small sample size, in addition to focusing on RAS pathway aberrations in the mathematical models, as other genetic and non-genetic determinants will likely cause resistance and disease progression, noted Sottoriva. This model will need to be prospectively validated in future trials, he added.
	5.1 Traitements - Pré-clinique
Study of Rare Cancer Yields Therapeutic Clues to Combat Drug Resistance [Brigham and Women's Hospital] Elledge, together with his graduate student Sida Liao, set out to explore cancer drivers that allow NUT midline carcinoma – a rare, aggressive cancer that can arise in multiple organs – to become impervious to drugs. Their results, published recently in Genes & Development, may apply to several forms of cancer fueled by the same mutated driver gene.
	5.12 Immunothérapies
FDA Workshop to Address Need for Non-clinical Models to Advance Immuno-oncology [Cancer Research Catalyst] The workshop will provide a forum for experts from academia, industry, the NCI, and the FDA to engage in a robust discussion on both scientific and practical aspects of developing these models for drug development of IO products, including how the models might be used to understand the safety of combination therapies.
	5.12.2 Immunothérapies - CAR-T, thérapies cellulaires
Sequoia leads $7M seed round for T-cell player RootPath [FierceBiotech] Details on its technology are slim, but the company has set its sights on bringing its lead asset into human trials in about two years, Chen said.
RootPath Raises $7M to Bring Cancer Cell Therapy to Solid Tumors [Xconomy] RootPath’s approach is similar to CAR-T up to a point, Chen says. T cells are collected, and they are ultimately infused back into the patient. But Chen says RootPath has developed technologies that enable it to analyze and sequence individual T cells, which helps identify the ones that are best suited to recognizing and fighting the tumor.
	5.12.3 Immunothérapies-combinaisons
Paediatric strategy forum for medicinal product development of checkpoint inhibitors for use in combination therapy in paediatric patients [EMA] This Forum will review the immunological environment of paediatric malignancies, results from the use of checkpoint inhibitors in early phase clinical studies in paediatrics, strategies combining checkpoint inhibitors with other products and alternative immunotherapy strategies.
	5.12.8 Immunothérapies - Economie
Engineered cell therapy given initial ‘no’ for NHS in England [Cancer Research UK] Meindert Boysen, director of the centre for health technology evaluation at NICE, said: “We have been working with the companies involved, and with NHS England, with the aim of ensuring that patients in England are among the first to have access to these new treatments in Europe.” "Although promising, there is still much more we need to know about CAR T," he added.
	5.2 Pharma
U.S. Food and Drug Administration Accepts Bristol-Myers Squibb’s Application for Sprycel (dasatinib) in Pediatric Patients with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia [BMS] Application based on results from Phase 2 CA180-372 study.
	5.3 Traitements - FDA, EMA, NICE...
FDA starts pilot to help sponsors use novel trial designs [FierceBiotech] Officials at the FDA committed to help advance the use of complex adaptive, Bayesian and otherwise novel clinical trial designs as part of the latest PDUFA agreement. These designs pose new challenges for sponsors such as the need to use simulations to determine trial operating characteristics, and therefore additional regulatory input is beneficial to ensure they meet the FDA’s expectations.
Towards improving the availability of medicines in the EU [EMA] Improving the availability of human and veterinary medicines authorised in the EU is a key priority of the EU Network. The work programme lists actions for regulators and industry alike to ensure the availability of medicines for the benefit of patients in the EU.
FDA launches pilot program in support of complex trial designs for drugs and biologics [EndPoints] The related efforts include new draft guidance documents on seamless clinical trials for expedited drug development and on the use of placebo-controlled trial designs, both of which were issued this month.
	6.1 Observation
For Nursing Home Patients, Breast Cancer Surgery May Do More Harm Than Good [KHN] A new study of 6,000 older patients shows little gain from surgeries for breast cancer.
	6.10 Politiques
‘No-deal’ Brexit: what the Government’s plans could mean for cancer treatment, care and research [Cancer Research UK] A big concern is that losing this cooperation could lead to delays for UK patients getting the newest medicines, or hinder international clinical trials where patients get access to the most innovative treatments. And from the notices released last week, the Government seem to agree.
	6.6 Publications
Financial disclosure lacking in publication of clinical trials [OHSU] A substantial proportion of pharmaceutical industry payments to authors of oncology clinical trials published in major scientific journals are not disclosed, new research shows. The publications focused on clinical trials that tested new cancer drugs.
	6.9 Controverses
Top UK genomics institute investigates bullying allegations [Nature] The institute is owned and funded by the Wellcome Trust, which, earlier this year, launched a pioneering policy aimed at stamping out bullying and harassment in laboratories that it funds.