Onco Actu du 4 décembre 2017

	1. Biologie
Brain organoids get cancer, too, opening a new frontier in personalized medicine [STAT] “The mouse models don’t recapitulate the human disease,” said Ravi Basavappa of the National Institutes of Health, which gave Fine one of its 12 Pioneer Awards for “unusually bold,” high-risk, and potentially high-impact research. “The hope is that [Fine’s organoids] will be a promising path forward.”
	3.3 Prévention - Vaccins
Fears for women’s health as parents reject HPV vaccine [The Guardian] Last week, doctors and health officials gathered in Dublin – centre of one of the most vociferous anti-vaccine campaigns – to discuss future tactics. Many believe the use of social media has added new impetus to anti-vaccine campaigners’ protests, and that this factor has been closely involved in the success of the attacks that have been made on immunisation programmes.
	3.6 Prévention - Activité physique
Incorporating Weight Management and Physical Activity Throughout the Cancer Care Continuum: Proceedings of a Workshop (2017) [National Academies Press] The purpose of this workshop was to highlight the current evidence base, gaps in knowledge, and research needs on the associations among obesity, physical activity, weight management, and health outcomes for cancer survivors, as well as to examine the effectiveness of interventions for promoting physical activity and weight management among people living with or beyond cancer.
	4.10 Dép., diag. & prono. - FDA, EMA, NICE,...
Will Foundation’s FDA, CMS Nod Help Cancer DNA Tests Break Through? [Xconomy] A major critique of broad tumor profiling tests is they can spit out a lot of data that, in the end, amount to an expensive exam that doesn’t accumulate useful signals, just noise.
FDA approves Foundation Medicine’s FoundationOne CDx, the first pan-tumour comprehensive genomic profiling assay incorporating a broad range of companion diagnostics [Roche] Of the 17 therapies currently approved for inclusion in the report, twelve are approved as first-line treatment options for their respective indications. The number of on-label targeted therapies in the report is expected to increase over time as Foundation Medicine and its partners gain FDA approval for additional biomarkers on the platform.
Foundation Medicine’s Cancer Gene Test Gains FDA and CMS Approval [The Scientist] F1CDx is the second in vitro diagnostic test to receive coordinated approval by the two agencies through the FDA-CMS Parallel Review Program, which aims to give Medicare beneficiaries earlier access to new medical technologies.
	4.2 Dép., diag. & prono. - Génome
The Rising Research Profile of 23andMe [The Scientist] As the data set has grown, so has the number of people in 23andMe’s research team, which now comprises 42 people, more than half of whom joined since 2015.
	5.12 Immunothérapies
HIV ‘cure’ based on one patient? Here’s what you need to know [Health News Review] One thing we don’t learn from The Guardian story is this: three out of the seven study authors have received payments from Bristol Myers Squibb, which makes nivolumab.
Researchers use PD-1 checkpoint drug in pursuit of a promising curative approach to HIV [EndPoints] There are some big caveats attached to this announcement. First, there was another HIV patient treated with nivo who didn’t respond. Second, they have to complete tox testing to see if non-cancer patients are threatened by checkpoint therapy. And they have to develop biomarkers for personalized treatment.
	5.12.4 Immunothérapies - Essais
Expanding Cancer Clinical Trial Access for Patients with HIV [NCI] For many years, NCI has recommended that people with HIV should not be arbitrarily excluded from cancer clinical trials and has enrolled people with HIV in immunotherapy trials. Early results from one such NCI-sponsored trial appear to validate the inclusion of appropriately selected HIV-positive people in immunotherapy clinical trials.
	5.12.5 Immunothérapies - Pharma
Bristol-Myers Squibb takes Opdivo to China's FDA after lung cancer survival win [FiercePharma] Bristol-Myers, which is battling rivals Merck and Roche in the U.S. lung-cancer space, certainly wouldn’t mind having the Chinese market all to itself—at least for now.
Bristol-Myers set to get a boost in China as Opdivo aces PhIII lung cancer study early [EndPoints] Big and little drug developers have been focusing more attention on China in the wake of a shakeup in its regulatory structure and a commitment to speed more drugs to the booming Asian healthcare market. China has a particularly high rate of lung cancer in a country where smoking is common.
	5.3 Traitements - FDA, EMA, NICE...
March 2019: EMA Updates Guidance on Brexit [RAPS] The European Medicines Agency (EMA) and the European Commission on Friday updated guidance for pharmaceutical companies on the UK’s departure from the EU, much of which hinges on March 2019 deadlines.
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 November 2017 [EMA] PRAC issues warning about use of prostate cancer medicine Xofigo in combination with Zytiga and prednisone or prednisolone.
What’s killing patients in Bayer’s Xofigo combo study? Researchers unblind study early to probe safety alert [EndPoints] Now they’ll begin the work needed to see why adding Xofigo — which uses targeted alpha radiation to kill cancer cells — would also trigger more deaths and fractures. This combination has been a key part of Bayer’s strategy to expand its market for Xofigo, which hit the market with bullish peak sales estimates of $1.5 billion.
	5.3.4 Traitements - AMM (FDA, EMA)
FDA Approves Eighth Biosimilar, First for Cancer Drug Herceptin [RAPS] Meanwhile, in the EU, Mylan withdrew its application for the Herceptin biosimilar, though just yesterday, the companies said that the European Medicines Agency has since re-accepted its application.
FDA approves first biosimilar for the treatment of certain breast and stomach cancers [FDA] The FDA’s approval of Ogivri is based on review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Ogivri is biosimilar to Herceptin. Ogivri has been approved as a biosimilar, not as an interchangeable product.
FDA OKs Mylan's biosimilar of Roche cancer drug Herceptin [Reuters] The U.S. Food and Drug Administration on Friday approved Mylan NV’s biosimilar of Roche’s blockbuster treatment for breast cancer, Herceptin, making it the second copycat cancer drug to be approved in the United States.
	6. Lutte contre les cancers
Siddhartha Mukherjee meets Henry Marsh: ‘When do you stop treating a patient? At 100?’ [The Guardian] "I think, again, that one of the failings of oncologists is that they don’t present to patients a landscape of what might happen."
	6.10.1 Politiques (USA)
ASCO Urges Senate to Avoid Medicare Cuts That Would be Triggered by Proposed Tax Bill [ASCO] Sixty percent of cancer patients are Medicare beneficiaries. A cut of this magnitude will cause increased instability in an already fragile cancer care delivery system and threaten access for patients with cancer.
	6.6 Publications
NIH to researchers: Don’t publish in bad journals, please [Retraction Watch] We also recognize that authors can sometimes feel pressure to publish their work quickly. In these cases, we would encourage authors to issue a preprint. They can post a preprint while they submit it to a peer-reviewed journal, or they can wait for community feedback to strengthen their manuscript.