Onco Actu du 4 juin 2019

	4.12 BIOPSIES LIQUIDES
Johns Hopkins Spinout to Bring CancerSEEK Test to Clinic [Genome Web] Unlike many molecular testing startups, the company is beginning its operations with a 10,000-person prospective trial, and conversations with regulators already underway.
	4.2 DÉP., DIAG. & PRONO. - GÉNOME
Is it Time to Integrate Polygenic Risk Scores into Clinical Practice? Let’s Do the Science First and Follow the Evidence Wherever it Takes Us! [Genomics and Precision health] As a result of new scientific findings, two camps have clearly emerged in the PRS world: the enthusiasts, who clearly think there is enough evidence for using PRS in certain clinical scenarios, and the skeptics who believe that we do not have enough evidence to justify such claims.
	5. TRAITEMENTS
Novel protocol significantly improves outcomes in locally advanced pancreatic [Mass. General Hospital] Combination of intensive chemotherapy, radiation therapy and blood-pressure drug losartan allows surgical removal of previously unresectable tumors, extends patient survival.
	5.2.3 PHARMA - ÉCONOMIE
Inhibrx, Fresh Off $40M Funding to Advance Cancer Drugs, Eyes IPO [Xconomy] It plans to use some of the funds to complete two ongoing Phase 1 clinical trials of experimental cancer drugs as well as a Phase 1 trial it plans to start for a drug intended to treat a rare respiratory disease, alpha-1 antitrypsin deficiency (AATD).
	5.3 TRAITEMENTS - FDA, EMA, NICE...
The FDA’s accelerated drug approval program is failing to protect cancer patients [Science-Based Medicine] Drug approval is a process that should be and, for the most part, is rooted in rigorous science. However, there is always a countervailing pressure to approve new drugs rapidly, particularly in cancer. That’s why the FDA created the accelerated approval program in the early 1990s. Unfortunately, increasingly this approval process appears to be failing us in oncology. Reform is needed.
FDA to make it easier for doctors to get unapproved cancer drugs for patients [Washington Post] The agency's oncology staff will work closely with physicians seeking treatments through the FDA's "expanded access" program.
FDA announces Project Facilitate to assist physicians seeking access to unapproved therapies for patients with cancer [FDA] The new pilot call center will enhance the FDA’s efforts to gather data on the Expanded Access program to help improve the process for physicians and patients.
US aims to help more cancer patients try experimental drugs [AP] Instead of making doctors plead their case first to companies and then to the FDA if the company agrees to provide the drug, the FDA will become the initial step and will assign a staffer to quickly do the paperwork. That way, when a company gets a request, it knows the FDA already considers it appropriate.
	5.3.4 TRAITEMENTS - AMM (FDA, EMA,...)
FDA approves addition of survival data to gilteritinib label for refractory AML with a FLT3 mutation [FDA] Approval was based on the ADMIRAL trial (NCT02421939), which included 371 adult patients with relapsed or refractory AML having a FLT3 ITD, D835, or I836 mutation by the LeukoStrat® CDx FLT3 Mutation Assay.
	6.10.1 POLITIQUES (USA)
‘Right-to-try’ laws provide little access to investigational drugs. We created a process that does [STAT] Our subsequent work with Janssen created a fair and ethical process for granting access to investigational drugs that works for patients.
	6.12 ETHIQUE
Research integrity is much more than misconduct [Nature] Research misconduct encompasses fraud, fabrication and plagiarism. It is essential to deal with such dishonesty thoroughly and fairly, but it’s patching up a tear after the damage is done. Research integrity includes such investigations, but it is much more. It is about creating systems that boost the quality, relevance and reliability of all research.
	6.6 PUBLICATIONS
Plan S Is Still Coming [In The Pipeline] What’s for sure, I’d think, is that scientific publishing will never again look like it did twenty years ago, or even ten. It’ll come down to the behavior of the next generations of scientists themselves, and their universities, governments, companies, and funding agencies.
Plan S and the Transformation of Scholarly Communication: Are We Missing the Woods? [The Scholarly Kitchen] The discussions around Plan S reflect the same vested interests we’ve heard for a couple of decades. Some of these are legitimate concerns (perhaps most notably societies anxious about how to fund the important work they do), but I see other forces at work in shaping more worrying trends.
	6.7.2 APPLIS
Tempus Announces (TIME) Trial Service, a New Integrated Molecular Evaluation that Leverages Artificial Intelligence to Rapidly Match Cancer Patients to Clinical Trials [Tempus] The TIME Trial is a proprietary platform that aims to solve this challenge by analyzing molecular and clinical patient data in real time and then routing patients to clinical trials at pre-qualified academic and community-based providers, ready to rapidly enroll patients or open the trial.
	6.9 CONTROVERSES
Jury smacks J&J with $325M talc verdict after a series of other wins [Fierce Pharma] After a 4-month trial, jurors ordered the company to pay $300 million in punitive damages, $20 million for Olson’s past and future pain, plus $5 million to her husband for loss of consortium. J&J said it plans to appeal, just as it has in the other talc cases it has lost.