Onco Actu du 29 août 2017

	4. Dépistage, diagnostic et pronostic
The science myths that will not die [Nature] Myth 1: Screening saves lives for all types of cancer.
STARD for Abstracts: essential items for reporting diagnostic accuracy studies in journal or conference abstracts [BMJ] STARD for Abstracts is a list of 11 quintessential items, to be reported in every abstract of a diagnostic accuracy study. We provide examples of complete reporting, and developed template text for writing informative abstracts.
	4.10 Dép., diag. & prono. - FDA, EMA, NICE,...
Concept Paper on Development and Lifecycle of Personalised Medicines and Companion Diagnostics [ESMO] The EMA’s proposed concept paper on predictive biomarker-based assay development in the context of drug development and lifecycle is intended to be developed into a guideline which will replace the reflection paper on co-development of pharmacogenomic biomarkers and assays in the context of drug development.
	5. Traitements
International Lenalidomide Trials Show Survival Benefit of Maintenance Therapy Following Transplant [Roswell Park Cancer Institute] Meta-analysis shows significant extension of survival for multiple myeloma patients receiving oral therapy.
	5.12.3 Immunothérapies-combinaisons
Bristol-Myers Squibb and Daiichi Sankyo Announce Research Collaboration to Evaluate Opdivo® (nivolumab) and DS-8201 in HER2-Expressing Breast and Bladder Cancers [BMS] The Phase 1b multicenter, open-label study will include two parts.
Concurrent Treatment with OX40- and PD1-targeted Cancer Immunotherapies May be Detrimental [AACR] “Our studies show that preclinical testing of immunotherapy combinations prior to taking it to clinical trials is very important, and we need more of that research.”
Bristol-Myers, Daiichi Sankyo to test Opdivo combo for cancers [Reuters] The companies said the clinical study in patients with HER2-expressing advanced breast and bladder cancer is expected to begin enrollment in the first quarter of 2018.
	5.2 Pharma
Aveo's phoenix drug tivozanib rises up in Europe [FierceBiotech] Fotivda will now be launched by E.U. licensee EUSA Pharma as a rival to Nexavar and other VEGF inhibitors—notably Pfizer's Sutent (sunitinib) and Novartis' Votrient (pazopanib)—as well as Pfizer's mTOR inhibitor Torisel (temsirolimus).
Aveo takes a big step forward as comeback plan delivers EU OK for tivo [EndPoints] FDA oncology chief Richard Pazdur led a brutal slapdown of Aveo when he took to the floor during the panel review. He argued vehemently against tivozanib, saying that a vote in favor of a drug that had produced data of an increased risk of death would set a dangerous precedent.
	5.2.2 Pharma - Fusions & Acquisitions
To Be More Than Quick Splash, Gilead’s CAR-T Purchase Faces Hurdles [Xconomy] Kite, which will operate as a division of Gilead, must navigate a minefield of technical and biological problems while outpacing well-heeled competitors. The deal prompted plenty of skepticism among public investors.
Kite's CAR-T medication, cancer candidates draw choosy Gilead for $12B pipeline-building buyout [FierceBiotech] A lot is resting on the bet, and both manufacturing concerns, as well as lingering safety worries from rival Juno's pipeline, could still cause issues with this cutting-edge tech.
Gilead Overspends to Quiet Deal Clamor [Bloomberg] There's a price tag on everything, possibly even happiness. For Gilead Sciences Inc. shareholders irate over the company's multi-year case of the deal yips as its growth stagnates, happiness apparently costs about $12 billion.
Gilead-Kite: A Breakthrough. A $12 Billion Deal. Another Expensive Drug [Forbes] But will that mean more controversy, too, as happened with Sovaldi, where Gilead cured a disease but was vilified for the price it charged? Milligan hopes not, pointing to the high price of cancer drugs in general. In fact, he says, the one-time cost of Axi-Cel could wind up being cheaper than long-term treatment with combinations of expensive drugs, like Merck’s Keytruda or Bristol-Myers Squibb’s Opdivo.
Diving deep into CAR-T, Gilead forges $12B buyout deal for Kite Pharma [EndPoints] The buyout will instantly make Gilead a leader in adoptive cell therapy, going head-to-head against Novartis’ leading effort with CTL019.
Gilead Tries to Repeat Home Run With $11.9 Billion Kite Deal [Bloomberg] The acquisition will pivot Gilead away from the antiviral treatments that have been the backbone of its business since at least 2001, to a cancer therapy that’s promising but has no commercial track record -- and plenty of risks.
	5.3 Traitements - FDA, EMA, NICE...
Statement from FDA Commissioner Scott Gottlieb, M.D. on the FDA’s new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine [FDA] To make sure the agency is separating the promise from the unscrupulous hype, we are stepping up our enforcement activity in this area.
	5.3.4 Traitements - AMM (FDA, EMA)
Two New Therapies Approved for Acute Myeloid Leukemia [NCI] The Food and Drug Administration (FDA) recently approved two new treatments for some adult patients with acute myeloid leukemia (AML): enasidenib (Idhifa®), a drug that targets aberrant forms of the IDH2 protein; and liposomal cytarabine-daunorubicin CPX-351 (Vyxeos™), a two-drug chemotherapy combination encapsulated in tiny fatlike particles called liposomes.
	6.6 Publications
A New Way for Doctors to Share Their Medical Mysteries [Wired] Cureus is the first and only peer-reviewed publication with step-by-step article templates for authors—which dramatically speeds up publication times. (Just like your tax software!) If case studies are published in weeks instead of months, that means millions more medical lessons to learn from.
	6.7.1 Bioinformatique
Why Everyone Is Hating on IBM Watson—Including the People Who Helped Make It [Gizmodo] “IBM Watson is the Donald Trump of the AI industry—outlandish claims that aren’t backed by credible data,” said Oren Etzioni, CEO of the Allen Institute for AI and former computer science professor.