Onco Actu du 23 septembre 2019

	1. BIOLOGIE
Neurons promote growth of brain tumor cells [DKFZ] “The tumor cells are not only interconnected in the brain like neurons; they also receive direct signals from them,” explained Winkler, whose research group is affiliated with the University Hospital and the DKFZ.
	3.1.1 PRÉVENTION - TABAC - E-CIGS
FDA issues proposed rule for premarket tobacco product applications as part of commitment to continuing strong oversight of e-cigarettes and other tobacco products [FDA] Under the PMTA pathway, manufacturers or importers must demonstrate to the agency, among other things, that marketing of the new tobacco product(s) would be appropriate for the protection of the public health. That statutory standard requires the FDA to consider the risks and benefits to the population as a whole, including users and non-users of tobacco products.
John Britton: Electronic cigarettes and the precautionary principle [BMJ] Those who cite the precautionary principle as justification to discourage or prohibit electronic cigarettes ignore the fact that for the great majority of users, the counterfactual is premature death from tobacco smoking. Smoking kills. So does denying smokers opportunities to quit.
FDA proposes rule over record-keeping for vape makers [Reuters] When finalized, the rule would also help to ensure that e-cigarette applications by manufacturers contain information on the product’s potential public health benefits and harms, the FDA said.
U.S. senators urge FDA to remove pod, cartridge-based e-cigarettes from market [Reuters] The letter said cartridge or pod-based systems account for more than 70% of the overall e-cigarette market, and are favored by youth.
Walmart to stop sales of e-cigarettes in U.S. stores: company memo [Reuters] In an internal memo seen by Reuters, the retailer said growing federal, state and local regulatory complexity and uncertainty were behind its decision.
Real-Time Digital Surveillance of Vaping-Induced Pulmonary Disease [NEJM] This report provides an integrated view of the vaping-related pulmonary disease outbreak since late July 2019. We collected online information from disparate sources including news aggregators, eyewitness reports, and validated official alerts and curated and classified the data by disease case, location, and time.
	4.9 DÉP., DIAG. & PRONO. - SEIN
Fewer lymph node operations for breast cancer patients with new prediction models [Lund University] The latest results that have now been published in Clinical Cancer Research and BMC Cancer show that up to one in every three operations could be avoided.
	5.1 TRAITEMENTS - PRÉ-CLINIQUE
Basic Science Discovery Leads to Clinical Trial for Patients with Chemotherapy-Resistant Form of Ovarian Cancer [Dana-Farber Cancer Institute} Laboratory studies showed that an HSP90-blocking compound called AT13387 worked in concert with DNA damage-inducing drugs such as PARP inhibitors to kill CCNE1-laden ovarian cancer cells.
After Uncovering Cause of Drug Resistance in Leukemia, Researchers Find Way to Overcome It [Dana-Farber Cancer Institute] Researchers treated tagraxofusp-resistant cancer cells with azacytidine and found, as expected, that it revived the activity of DPH1 and made the cells vulnerable to tagraxofusp. When they tested a combination of tagraxofusp and azacytidine in models of human AML and BPDCN, the duo drove the disease into remission.
New family of drugs which could combat prostate cancer identified at University of Bath [University of Bath] In this study a new family of drugs which inhibit AMACR (α-methylacyl-CoA racemase) is reported. The structure of the side-chain was systematically varied in order to identify important structural features which are required for highly effective inhibition of AMACR activity.
	5.12.11 IMMUNOTHÉRAPIES - PRÉ-CLINIQUE
Ancient viruses could help kill cancers [The Francis Crick Institute] In this study, we looked for viral DNA that is reactivated by cancer and produces products that the immune system can see. The hope is that if we can train the immune system to spot these, we can selectively target cancer cells.
	5.3 TRAITEMENTS - FDA, EMA, NICE...
Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products [FDA] Draft Guidance for Industry.
	5.3.4 TRAITEMENTS - AMM (FDA, EMA,...)
EMA Recommends Granting a Marketing Authorisation for Gilteritinib [ESMO] This product was designated as orphan medicine during its development. EMA will now review the information available to date to determine if the orphan designation can be maintained. AML is a rare type of malignancy. It affects approximately 1 in 10,000 people in the European Union.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 2019 [EMA] - The Committee recommended granting a marketing authorisation for Xospata* (gilteritinib) for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation. - The CHMP recommended granting marketing authorisations for three generic medicines: Arsenic trioxide Accord (arsenic trioxide), for the treatment of acute promyelocytic leukaemia; Bortezomib Fresenius Kabi (bortezomib), for the treatment of multiple myeloma and mantle cell lymphoma; and Ivozall (clofarabine), for the treatment of acute lymphoblastic leukaemia in paediatric patients.
Astellas' AML drug wins over CHMP — strengthening lead on Daiichi Sankyo [EndPoints] The CHMP thumbs up widens the gap between Astellas and Daiichi Sankyo, which has run into a roadblock at the FDA when trying to field its own FLT3 targeted therapy after being green-lighted in Japan.
	5.6 ESMO
Bayer data at ESMO 2019 highlights innovation in cancer research [Bayer] Across Bayer’s prostate cancer franchise, data from the Phase III ARAMIS trial evaluating the clinical relevance of drug-drug interactions (DDI) with investigational androgen receptor inhibitor (ARi) darolutamide (Nubeqa®) will be presented.
Roche to present new data from its broad oncology portfolio at the European Society for Medical Oncology 2019 Congress [Roche] First positive results from a Phase III cancer immunotherapy combination study in people with previously untreated advanced bladder cancer.
	6.10 POLITIQUES
Drug and medical suppliers say Brexit freight plans needed urgently [Reuters] Despite repeated and urgent requests to the government for details, medicines suppliers still don’t know which ports such shipments will depart from, the timings and lengths of the journeys or where they will arrive in the UK.
	6.10.1 POLITIQUES (USA)
NIH set for $3B funding boost under Senate budget proposal [Fierce Biotech] Despite President Donald Trump repeatedly threatening to cut the NIH’s budget, the agency has received more money in recent years as a result of support in Congress. That pattern looks set to continue in fiscal 2020, with the Senate Committee on Appropriations proposing another increase to the NIH’s budget.