Onco Actu du 28 janvier 2019

	1.4 BIOLOGIE - TECHNOS
2019 Tech Speculations: Oxford Nanopore [Omics! Omics!] Getting into the clinic is a priority for any company selling biological analysis capabilities. Each time I go to a nanopore meeting, it seems another good application surfaces -- pre-implantation cytogenetics that avoids freezing embryos, rapid diagnosis of infections to match antibiotics to bugs*, rapid diagnosis of cancer fusions to match tumors to drugs. Some of these not only have the speed advantage, but also long reads are inherently better than short.
	2. ETIOLOGIE
Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on the FDA’s ongoing investigation into valsartan and ARB class impurities and the agency’s steps to address the root causes of the safety issues [FDA] Our analysis of NDMA found that the risk to patients based on the maximum possible exposure appears to be small. That doesn’t diminish our concern and our determination to find out how these impurities occurred in the first instance.
A cancer-causing contaminant went undetected for years in widely used blood pressure medicines [Washington Post] The FDA first realized there was a cancer-causing contaminant in widely used drugs in June. Seven months later, they're still recalling batches.
	5.1 TRAITEMENTS - PRÉ-CLINIQUE
MD Anderson study shows FGL2 protein may be an effective target for glioblastoma [MD Anderson Cancer Center] Findings from the study indicate FGL2 (fibrinogen-like protein 2), which is known for suppressing the immune system, is highly expressed in GBM. Investigators showed that inactivating or “knocking out” FGL2 from the tumor cells can eliminate tumor progression in mice with intact immune systems.
Targeting Brachyury Transcription Factor Addiction in Chordoma [ESMO] Identification of therapeutic targets in chordoma has been challenging so far, due to the infrequent occurrence of clinically actionable somatic mutations. The latest study revealed that the developmental transcription factor T (brachyury; TBXT) is the top selectively essential gene in chordoma.
	5.2.1 PHARMA - PARTENARIATS
GSK, Sanofi enlist in a big genomics project aiming to map genes of half a million Finns [EndPoints] GSK and Sanofi have now joined the effort, bringing the total number of pharmaceutical partners to nine. The project, called FinnGen, utilizes blood samples from biobanks to chart genomic data and then analyzes it with information from national health records.
	5.3 TRAITEMENTS - FDA, EMA, NICE...
Lilly's tarnished Lartruvo faces uncertain future after FDA red-flags new patient starts [Fierce Pharma] The regulatory moves put Lartruvo's future further in doubt. Lilly itself had already taken the unusual step of halting its Lartruvo marketing.
FDA, EMA recommend against starting patients on Lilly's Lartruvo [Biopharma Dive] Both the EMA and FDA had granted Lartruvo early approval based on Phase 2 results that indicated the medicine could prolong overall survival and progression-free survival when given in combination with the existing cancer treatment doxorubicin. Yet data from the larger Phase 3 trial showed no significant survival benefit when compared with doxorubicin alone.
In another setback for Eli Lilly, FDA follows EMA in calling for a halt to new Lartruvo prescriptions [EndPoints] The agency has recently finalized its guidance on labeling therapies OK’d under the accelerated approval pathway, providing more structure for a mechanism that it seems increasingly eager to use.
	5.3.4 TRAITEMENTS - AMM (FDA, EMA,...)
U.S. FDA Approves IMBRUVICA® (ibrutinib) Plus Obinutuzumab as First Non-Chemotherapy Combination Regimen for Treatment-Naïve Patients with Chronic Lymphocytic Leukemia [Janssen] - Patients treated with IMBRUVICA plus obinutuzumab experienced a 77 percent reduction in risk of progression or death compared to chlorambucil plus obinutuzumab.
	6. LUTTE CONTRE LES CANCERS
WATCH: He wanted to see his cancer from the inside. With virtual reality, he can [STAT] Oncologist Dr. Ray Mak and researcher Christopher Williams recently invited Hobbs to take part in an early trial of the virtual reality technology. Physicians can use it to better visualize scans than that offered by traditional imaging techniques, and it may also give patients greater insight into their treatment plan.
	6.10 POLITIQUES
UK looks to ensure pharma submissions can continue under no deal Brexit [EndPoints] “If the UK leaves the EU with no deal, the UK would no longer be part of the EU medicines and medical devices regulatory networks. Submissions related to human medicines would need to be submitted directly to the MHRA,” the agency said.
Novartis sounds alarm on unsustainable drug supply chain if no-deal Brexit becomes reality [EndPoints] A chaotic no-deal departure could be catastrophic for UK patients, as 73% of pharmaceutical imports come in from the EU, according to a House of Commons report published last year.
Drug firm Novartis fears no-deal Brexit could put patients at risk [The Guardian] Novartis urged NHS trusts and pharmacists to refrain from stockpiling medicines so supplies could be managed centrally. This would minimise “the risk of medicine shortages across the UK”, it said.
Novartis urges Britain to secure drug supplies before Brexit [Reuters] Novartis called on Britain to urgently guarantee the movement of drugs in the event of a chaotic Brexit and said it was stockpiling to maintain the delivery of the 120 million packs it exports to Britain from Europe each year.
	6.11 PATIENTS
Cancer cliches to avoid: I'm not 'brave' [BBC News] Calling a person's cancer diagnosis a "war" or a "battle" and saying they had "lost their battle" or "lost their fight" when they died, were other unpopular descriptions, according to the poll carried out by YouGov.
	6.6 PUBLICATIONS
Richard Smith: Pharmaceutical companies follow public funders of research in efforts to reform science publishing [BMJ] At the meeting the pharmaceutical companies were challenged to leapfrog over years of slowly ratcheting up their policies, as most public funders have done, and join cOAlition S; the coalition supporting Plan S, which has been developed by the European Union and requires that all research it funds must be immediately and fully open access from the start of 2020.
	6.7 DMP, BIG DATA & APPLIS
Julia Lab joins team to speed up drug approval process [MIT] The team aims to leverage real-world evidence, observational data that are generated during routine clinical practice, and patient health care databases to augment label claims and/or support new drug applications with leading-edge software and algorithms and a depth of regulatory and clinical experience.
Filling the gaps in a patient’s medical data [MIT] Neural network assimilates multiple types of health data to help doctors make decisions with incomplete information.