Onco Actu du 6 mars 2019

	2. ETIOLOGIE
Statement from FDA Commissioner Scott Gottlieb, M.D., and Susan Mayne, Ph.D., director of the Center for Food Safety and Applied Nutrition, on tests confirming a 2017 finding of asbestos contamination in certain cosmetic products and new steps that FDA is pursuing to improve cosmetics safety [FDA] The FDA is today announcing the results of these tests. Those tests confirmed the presence of asbestos in three of the product samples collected from Claire’s and one of the product samples collected from Justice.
	4.10 DÉP., DIAG. & PRONO. - POUMON
Lung Cancer Diagnostic Approach Takes Aim at Identifying Malignancy, Guiding Immunotherapy From Single Sample [Genome Web] In a study published recently in The Journal of Molecular Diagnostics, researchers at RMIT University in Victoria, described collecting bronchial brushings that may enable diagnosing non-small cell lung cancer patients, determining the stage of their diseases, and guiding management of immunotherapies based on PD-LI expression.
	4.12 BIOPSIES LIQUIDES
Closer to the clinic: cerebrospinal fluid as liquid biopsy for the real time policing of brain cancer [VHIO] “Liquid biopsy of CSF is showing increasing promise. Blood plasma is low in ctDNA, whereas CSF is enriched in mutations in brain tumors and has been validated.”
	4.2 DÉP., DIAG. & PRONO. - GÉNOME
What now for 100,000 Genomes Project participants? [Genomics England] We are aiming to analyse everyone’s genome for the first time and returning results back to the NHS by July 2019. Then there will be a little bit of a delay while they look at those reports and consider whether it is reliable enough to give that information back to the participants, as these clinicians are the ones caring for those patients.
Genomic testing of a single patient reveals a gene commonly mutated in pediatric melanoma [St. Jude Children's Research Hospital] Comprehensive clinical genomic testing of an adolescent patient, including whole genome sequencing, helped researchers identify mutations in a single gene that drive the most common childhood melanoma. The St. Jude Children’s Research Hospital study appears as an advance online publication today in the journal Nature Medicine.
	5. TRAITEMENTS
Radiation after surgery triples survival for a type of pediatric brain tumor [St. Jude Children's Research Hospital] A Children's Oncology Group study shows that postoperative radiation improves outcomes for children with ependymoma, even those with historically poor prognoses and the very young.
	5.1 TRAITEMENTS - PRÉ-CLINIQUE
How A Common Oral Bacteria Makes Colon Cancer More Deadly [Columbia University] In the current study, the researchers found in cell cultures that noncancerous colon cells lack a protein, called Annexin A1, which stimulates cancer growth. They then confirmed both in vitro and later in mice that disabling Annexin A1 prevented F. nucleatum from binding to the cancer cells, slowing their growth.
Promising New Pancreatic Cancer Treatment Moves Forward [Huntsman Cancer Institute] The new HCI study, using an approach that simultaneously targets both abnormal KRAS signaling and the autophagy process, shows a strong response in mouse models and may be a promising therapy for patients with pancreatic cancer.
	5.10 TRAITEMENTS - ESSAIS
Anti-CD47 antibody trial in advanced cancers shows treatment appears safe, well-tolerated [Stanford] In 2009, researchers in the laboratory Stanford stem cell biologist Irving Weissman, MD, showed that CD47 on human leukemia stem cells acts as a "don't eat me" signal to the immune cells called macrophages that patrol the body to eliminate infected and diseased cells. Blocking this signal with a CD47-binding antibody called H5F9-G4, or 5F9, restores the ability of macrophages to recognize and kill cancer cells in the laboratory and in mouse models of human disease.
	5.2 PHARMA
Oncology pipeline chief Alessandro Riva joins the exodus at Gilead, heading to helm a biotech spinoff 4 days after O’Day’s arrival as CEO [EndPoints] Now the big question is what O’Day will do to restore confidence in Gilead, which relies on a stable set of HIV drug leaders as its hep C franchise dwindles and the future of CAR-T remains an open question mark.
	5.2.2 PHARMA - FUSIONS & ACQUISITIONS
2 months after BMS megamerger, Celgene's JAK inhibitor to get priority review [Fierce Biotech] Fedratinib is just one of several late-stage programs that BMS will pick up in the acquisition; the others include a CAR-T treatment for multiple myeloma, ozanimod to treat multiple sclerosis and luspatercept for beta thalassemia.
U.S. FDA Grants Priority Review for Fedratinib New Drug Application in Myelofibrosis [Celgene] The NDA for fedratinib is based on results from a randomized, placebo-controlled, phase 3 trial (JAKARTA)in patients with primary or secondary myelofibrosis, as well as a single-arm, open-label phase 2 trial (JAKARTA2) in patients with primary or secondary myelofibrosis previously exposed to ruxolitinib, the only FDA-approved treatment for the disease.
Celgene checks regulatory box for key drug in Bristol-Myers deal [Biopharma Dive] Celgene announced the FDA has accepted its New Drug Application for fedratinib, a drug for myelofibrosis. The regulator granted Priority Review to Celgene's submission, setting up a decision on approval by Sept. 3, just six months from now.
	5.2.3 PHARMA - ÉCONOMIE
Celgene slipped up repeatedly last year. So why did CEO Mark Alles get a raise? [Fierce Pharma] Investors will vote on the BMS-Celgene merger in April, and Alles’ postdeal future with the company is unclear. His financial security, however, is guaranteed: He will get about $27.9 million if he leaves the company after the deal closes, according to a proxy statement filed with the SEC last week.
AstraZeneca pays CEO Soriot nearly $15M after 2018's return to growth. Will investors push back? [Fierce Pharma] For the first time, AZ also released its CEO-to-worker pay ratio, disclosing that Soriot made 160 times the average AZ employee’s salary last year, according to its annual report.
	5.3 TRAITEMENTS - FDA, EMA, NICE...
Popular FDA commish Scott Gottlieb has handed in his resignation [EndPoints] The big question now is who will replace him. Trump freaked out many execs by entertaining Peter Thiel’s push for a libertarian approach, which would have erased many of the barriers to introducing new drugs — along with the credibility that goes with an FDA sanction.
F.D.A. Commissioner Scott Gottlieb, Who Fought Teenage Vaping, Resigns [NY Times] His announcement caught many in Washington and the industries he regulates by surprise and raised questions about whether his push to reduce teenage vaping and lower nicotine levels and ban menthol in cigarettes will continue in an administration that generally has a hands-off approach to business.
Scott Gottlieb’s sudden resignation will give biotech a panic attack [STAT] It’s not hyperbolic in the least to say that biopharma loved Gottlieb. He was an FDA commissioner who fully embraced the “innovation” mantra and was eager to put in place new policies and guidelines that streamlined the review and approval process.
Head of US food and drug agency resigns [Nature] Gottlieb, a physician and venture capitalist who has served on the boards of several pharmaceutical companies, became known at the FDA for his aggressive plan to crack down on the sale of flavoured e-cigarettes to curb underage vaping.
	5.3.4 TRAITEMENTS - AMM (FDA, EMA,...)
EMA Recommends Granting a Conditional Marketing Authorisation for Lorlatinib [ESMO] It is intended for treatment of patients with ALK-positive advanced NSCLC previously treated with other ALK tyrosine kinase inhibitors.
	6. LUTTE CONTRE LES CANCERS
Shortages of pediatric cancer medicines threaten outcomes [Baylor College of Medicine] In addition to compiling a list of essential drugs, the authors also provide recommendations on what to do when there are shortages, as well as how to forecast need in the future.
Multipronged Approach Eliminates Racial Disparities in Early-Stage Lung Cancer Treatment [NCI] The three-pronged approach included: a real-time warning system tied to electronic health records, to keep patients from falling through the cracks; feedback to clinical teams on treatment completion rates for black and white patients; and trained nurse navigators to engage with patients to identify and resolve barriers to care.
	6.1 OBSERVATION
Cancer patients with mental health problems less likely to survive, study suggests [The Telegraph] Those who had visited their GP about their mental health prior to their cancer diagnosis were on average five per cent more likely to die from their disease compared to someone who had never sought psychiatric help.
People with bladder cancer waiting up to five months for treatment [The Guardian] Patients with bladder cancer are having to wait almost five months for treatment, far beyond the 62 days that NHS rules say is the longest delay anyone should face.
	6.10 POLITIQUES
Brexit 'likely to cause cancer test delays' [BBC News] The Royal College of Radiologists has told doctors to prepare for possible delays for some drugs used to detect cancer if there is a no-deal Brexit. It says clinicians should reduce their workload in the days after 29 March, when the UK is due to leave the EU.
	6.11 PATIENTS
Ovarian Cancer Awareness Month: Knowledge of BRCA2 gene is power [Institute of Cancer Research] This Ovarian Cancer Awareness Month our Cancer Stories Officer, Lydia Brain, spoke to Davina Gardner – a survivor of ovarian and breast cancer – about being a BRCA2 gene carrier and how it has affected her and her family.
	6.12 ETHIQUE
China creating national medical ethics committee to oversee high-risk clinical trials [STAT] “The He affair is not an isolated incident,” Ma said. For decades, the country has been plagued by successive waves of problematic medical research involving hyped interventions such as stem-cell transplantation, gene editing in adults, and cancer immunotherapy.
	6.5 MÉDECINES ALTERNATIVES/COMPLÉMENTAIRES
Cancer crowdfunding 'couldn't save my daughter' [BBC News] When Gemma Nuttall developed cancer, her family raised thousands of pounds online, with the support of actress Kate Winslet, to send her to a German clinic. But there was no happy ending - and fears remain that crowdfunding puts new pressure on vulnerable families.
	6.6 PUBLICATIONS
Plan S – Time to decide what we stand for [LSE Impact Blog] The whole point of Plan S was to disrupt the status quo and transform the world of scholarly publishing. If it yields to those who it is trying to disrupt, at the cost of the greater good, than that’s not exactly progress. Open Access is not a business model, so let us stop treating it as such.
Springer Nature Now Shares Select Papers on ResearchGate [The Scientist] With this new initiative, articles published in 23 Nature journals, including Nature, Nature Medicine, and Nature Neuroscience, between November 2017 and this March will be freely accessible from scientists’ ResearchGate pages.
	6.7 DMP, BIG DATA & APPLIS
IQvia Launches Genomics Technology Platform [Genome Web] IQvia, the product of the 2016 merger of Quintiles and IMS Health, holds a patent on the privacy aspect of the database for techniques to strip away phenotypic and identifying data from genomics records without fully severing the link between clinical and genomics data to facilitate efficient research.
IQVIA debuts research platform to de-ID links between genomic and clinical data [Fierce Biotech] The platform allows life science customers to aggregate data to conduct various research projects, including association studies of genomics and observable traits, as well as comparative safety and efficacy trials. It can also securely track burden-of-illness and perform discovery analytics using de-identified data, according to the company.