Onco Actu du 2 mai 2017

	1. Biologie
New model could speed up colon cancer research [MIT News] Using the gene-editing system known as CRISPR, MIT researchers have shown in mice that they can generate colon tumors that very closely resemble human tumors.
	2.10 Etiologie - Alcool
Study confirms link between alcohol consumption, breast cancer risk in black women [UNC Linberger] In findings published in the journal Cancer, Epidemiology, Biomarkers & Prevention, UNC Lineberger Comprehensive Cancer Center researchers confirmed the link between alcohol consumption and breast cancer risk in a study in black women. The association has been seen in other studies drawn from majority white populations.
	4. Dépistage, diagnostic et pronostic
New Imaging Method May Predict Immunotherapy Response Early [AACR] Mahmood and colleagues designed a probe that binds to granzyme B—a protein that immune cells release to kill their target—after it is released from the immune cells, so they could directly measure tumor cell killing. The researchers attached the probe to a radioactive atom and used PET scanning to noninvasively image the entire body and see where immune cells are actively releasing tumor-killing granzyme B.
	4.1 Dép., diag. & prono. - Prostate
With $40M in New Cash, Epic Sciences Advances Diagnostic for Late-Stage Prostate Cancer [Xconomy] The company said its first diagnostic test, the OncotypeDx AR-V7 Nucleus Test, is intended to determine whether a patient with late-stage prostate cancer would respond to hormone-based therapy or should be switched to chemotherapy.
	4.10 Dép., diag. & prono. - Poumon
ELCC 2017 Press Release: Men Need More Frequent Lung Cancer Screening Than Women [ESMO] “Our study suggests that the annual follow-up interval for CT is too frequent for women, and scans every 2–3 years might be suitable. By reducing the number of unnecessary CT scans, we can decrease radiation exposure and increase cost effectiveness.”
	4.12 Biopsies liquides
Serial Analysis of Circulating Tumor Cells May Provide Biomarker Predictive of Lung Cancer Response to Crizotinib [AACR] “In this study, we showed that analysis of ALK copy number in CTCs before starting crizotinib treatment and after two months of crizotinib treatment may provide a biomarker for predicting the effectiveness of the therapeutic.”
	4.5 Dép., diag. & prono. - Colorectal
Follow-up colonoscopy cuts bowel cancer cases in some people [Cancer Research UK] The findings suggest that patients at intermediate risk of developing bowel cancer who had at least one follow-up colonoscopy after screening were less likely to develop the disease. And there may be some patients at low risk who weren’t benefiting from follow-up colonoscopy.
	4.7 Dép., diag. & prono. - Col de l'utérus
The Pap smear: groundbreaking, lifesaving — and obsolete? [STAT] Proponents of HPV self-testing say its biggest appeal is in expanding the reach of cancer screenings, both to impoverished areas abroad, and also to women closer to home.
	5. Traitements
Overcoming cancer evolution with collateral sensitivity and drug holidays [EvMed Review] These experimental results, they say, indicate that lorlatinib might be a poor choice for first-line therapy, as the cross-resistance it generates is substantial and stable through drug holidays, but it may be a better choice in the second-line, as many resistant lines are sensitized towards it after a drug holiday.
	5.12.6 Immunothérapies - AMM
Welcome Imfinzi: AstraZeneca crashes the checkpoint party late with a green light for durvalumab [EndPoints] The FDA handed out its latest approval for a PD-L1 checkpoint inhibitor on Monday afternoon, giving a green light to AstraZeneca to start selling durvalumab as Imfinzi as a second-line therapy for metastatic urothelial carcinoma.
Durvalumab (Imfinzi) [FDA] On May 1, 2017, the U.S. Food and Drug Administration granted accelerated approval to durvalumab (IMFINZI, AstraZeneca UK Limited) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
European Commission Approves Bristol-Myers Squibb’s Opdivo (nivolumab) for Squamous Cell Cancer of the Head and Neck in Adults Progressing On or After Platinum-based Therapy [BMS] Opdivo is the first and only Immuno-Oncology agent to receive European approval for the treatment of squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy.
Genmab Announces European Marketing Authorization for DARZALEX® (daratumumab) for Relapsed or Refractory Multiple Myeloma [Genmab] Genmab to receive milestone payments totaling USD 48 million from Janssen upon the first sale of DARZALEX in the newly approved indications.
AstraZeneca immunotherapy wins first approval in bladder cancer [Reuters] Durvalumab's big commercial opportunity lies in previously untreated lung cancer, where key clinical trial results are due in June or July.
	5.2 Pharma
Genmab Announces New Phase III Combination Study of Daratumumab in Multiple Myeloma [Genmab] Phase III study of daratumumab in combination with pomalidomide and dexamethasone in relapsed and refractory multiple myeloma.
	5.2.2 Pharma - Fusions & Acquisitions
Bristol-Myers drops option to buy HER2 cancer biotech [FierceBiotech] Bristol-Myers has disclosed little about its motivations, simply saying it had discontinued development of anti-HER2 antibody fragment FS102 and won’t be exercising its option to acquire F-star Alpha.
	5.3 Traitements - FDA, EMA, NICE...
EMA and heads of national competent authorities discuss consequences of Brexit [EMA] Key principles and working methodology established.
Scott Gottlieb And The Goldilocks Theory Of Bringing Change To The FDA [Health Affairs Blog] The FDA has long maintained that is does not have a direct role to play in drug pricing. Given the current volume of the debate, the agency is going to find it harder to stay on the sidelines.
	5.3.4 Traitements - AMM (FDA, EMA)
U.S. FDA approves Novartis' leukemia treatment [Reuters] In a late-stage trial on AML patients, the median duration of therapy (50 mg administered twice a day) was 42 days, implying a list price of $22,485, Masow added.
Novartis bags FDA OK for Rydapt, adding a new chemo combo drug for AML [EndPoints] The agency’s statement on the approval — the 16th to date during what is proving to be a much more productive year than last year — notes that investigators never did nail down a reliable median survival benefit in their studies.
Novartis receives FDA approval for Rydapt® in newly diagnosed FLT3-mutated acute myeloid leukemia (AML) and three types of systemic mastocytosis (SM) [Novartis] Rydapt is the only approved targeted therapy for newly diagnosed FLT3-mutated AML.
FDA approves new combination treatment for acute myeloid leukemia [FDA] The drug mitostaurin is approved for use with a companion diagnostic, the LeukoStrat CDx FLT3 Mutation Assay, which is used to detect the FLT3 mutation in patients with AML.
Takeda Announces FDA Accelerated Approval of ALUNBRIG™ (brigatinib) [Takeda] ALUNBRIG Approved for ALK+ Metastatic Non-Small Cell Lung Cancer (NSCLC) Patients Who Have Progressed on or are Intolerant to Crizotinib.
U.S. FDA approves Takeda's lung cancer drug as second-line treatment [Reuters] Japan's Takeda Pharmaceutical Co Ltd said on Friday that the U.S. Food and Drug Administration approved its lung cancer drug, almost three months after the company acquired the drug's developer, Ariad Pharmaceuticals Inc.
Takeda gets a potential blockbuster bonus on $5B Ariad deal with FDA’s approval of brigatinib [EndPoints] Takeda can now set out to realize its projections of $1 billion-plus in annual sales for brigatinib — which will be marketed as Alunbrig — which are significantly more aggressive than most analysts, who have been predicting $500 million to $800 million in sales.
Takeda's Ariad deal pays off with blockbuster green light for Alunbrig [FiercePharma] Takeda execs have high hopes for the therapy, one of the key assets in its $5.2 billion Ariad buy.
	5.4 Traitements - Economie
Cancer Drugs Fund poor value for money, study finds [PharmaTimes] According to the research, when other factors such as quality of life and toxic side effects of the drugs were considered as part of criteria developed by oncologists to measure value to patients, the majority of CDF funded drugs failed to show any evidence of meaningful clinical benefit.
What Is Maddening About Pharmaceutical Prices [Forbes] The pharmaceutical industry deserves to profit from its labors. But these kind of price hikes, years after drugs come to market? It’s almost like pharmaceutical executives are begging for price regulation.
	6. Lutte contre les cancers
Waiting and watching with ‘Stage 0’ breast cancer put to nationwide test [Washington Post] A growing group of oncologists, worried about overtreatment, is stepping up efforts to add another approach — active surveillance — to the anti-DCIS arsenal. Proponents are launching COMET, the nation’s first prospective, randomized clinical trial to test whether such close monitoring is safe and effective for many women.
Defending Biomedical Science in an Era of Threatened Funding [JAMA] In a new narrative for defending science, interest groups should focus more on how they struggle to improve research practices and their validity and reproducibility, instead of touting moonshots and cures for cancer.
	6.10.1 Politiques (USA)
ASCO Applauds Congress for Providing Additional $2 Billion in NIH Funding [ASCO] While we're encouraged by the funding increase in the FY17 bill, we will continue to strongly advocate for robust funding levels for FY18. Scientific innovation doesn't happen overnight and requires sustained support.
Taking a ride on the NIH budget rollercoaster [STAT] Almost every organization, and the NIH is no exception, has the possibility of reducing waste and increasing efficiency. But that should come through smart planning, not a blindly applied axe.
The NIH Looks Trump-Proof [Bloomberg] The list of things Republicans and Democrats currently agree on likely doesn't exceed 250 words, but there's common ground on funding cancer and Alzheimer's research.
How science fares in the U.S. budget deal [Science] Another $160 million in new funding goes to the Precision Medicine Initiative (including $40 million from Cures for its 1-million person cohort study). And $300 million from Cures tagged for the National Cancer Institute is expected to fund former Vice President Joe Biden’s moonshot initiative.
ASCO Strongly Opposes AHCA in Current Form, Urges “No” Vote in House [ASCO] We are concerned that provisions in this legislation would erode key protections for patient access to cancer care, including pre-existing condition safeguards, coverage for essential health benefits, and access to affordable health insurance.
Science wins reprieve in US budget deal [Nature] Congress gives National Institutes of Health a big boost and avoids cuts to research agencies sought by Trump.
Trump: Slash the health research budget. Congress: No. [Vox] Lawmakers increased the agency’s budget by $2 billion for the second year in a row.
	6.6 Publications
Nature Journals to Authors: Get Hip to ORCID [The Scientist] Researchers submitting manuscripts to the Nature family of journals, as well as other Springer titles need to register for a unique author identifier.
Springer Nature announces new ORCID initiatives [Springer] The first initiative is a trial that will mandate ORCID iDs for corresponding authors publishing in 46 journals from across the whole of Springer Nature, including Nature Research, Springer and BioMed Central from today. The second initiative will see Springer become the first publisher to include ORCID iDs in proceedings papers.
	6.7.1 Bioinformatique
Deep Learning Is a Black Box, but Health Care Won’t Mind [MIT Technology Review] Price says that may not pose a serious obstacle in health care. He likens deep learning to drugs whose benefits come about by unknown means.
	6.7.3 DMP
Cancer patients in limbo as five hospitals suffer 'major' IT crash [The Telegraph] Doctors at five large London hospitals have reported 11 days of “chaos” after the systems used to prescribe chemotherapy doses and share x-ray and MRI images broke down on April 20.
	6.9 Controverses
University of Utah health system CEO resigns after cancer center flap [STAT] She stepped down after a fight over the university’s cancer center with its chief benefactor, the powerful Huntsman family.
Breast surgeon Ian Paterson needlessly harmed patients [BBC News] Ian Paterson, 59, carried out "extensive, life-changing operations for no medically-justifiable reason". He was found guilty of 17 counts of wounding with intent, relating to nine women and one man.
Software Eats the World, But Biology Eats It [In the Pipeline] The Silicon Valley types are particularly vulnerable, because they don’t know what biology is like (or how little we understand), and they can be particularly eager to sell you things, too, so be especially wary from that direction.