Onco Actu du 31 août 2017

	2.6 Etiologie - Environnement
France to vote against license renewal for weedkiller glyphosate [Reuters] A vote on whether to renew the license is due on Oct. 4, the French official said. A qualified majority of member states is needed for the renewal to go ahead.
	3.1.1 Tabac - e-cigs
Most young people who try e-cigarettes don’t become regular users, says study [Cancer Research UK] The study, part-funded by Cancer Research UK, collated 5 surveys that questioned more than 60,000 young people in total, aged 11-16.
	3.8 Prévention - Alimentation
The fat vs. carbs merry-go-round spins again [HealthNewsReview] The study authors appropriately mentioned — but very few reporters discussed — the confounding issue of socioeconomic status at play in this international study.
	5. Traitements
Modified Stem Cells Deliver Chemotherapy to Metastatic Tumors [NCI] An exciting characteristic of the approach, Dr. Kaplan continued, is that it is adjustable and dynamic, which means that it may potentially be fine-tuned to an individual patient’s needs.
	5.12 Immunothérapies
Beta Blockers May Hold Key to Unleashing Potential of Checkpoint Inhibitors, Roswell Park Team Shows [Roswell Park Cancer Institute] Existing therapies capable of reducing stress responses may boost effectiveness of immunotherapy.
	5.12.2 Immunothérapies - CAR-T
FDA approves Roche’s Actemra/RoActemra (tocilizumab) for the treatment of CAR T cell-induced cytokine release syndrome [Roche] Actemra/RoActemra is the first FDA-approved treatment for severe or life-threatening cytokine release syndrome induced by CAR T cell therapy.
	5.12.5 Immunothérapies - Pharma
Star team quietly raises $21M to launch the latest immuno-oncology startup Torque [EndPoints] We want to activate only the T cells that are going after the tumor, and we do this by anchoring the immunomodulators to the surface of the immune cell to act locally, in the microenvironment.
	5.12.6 Immunothérapies - AMM
FDA Approves Pioneering Cancer Treatment With $475,000 Price Tag [Wall Street Journal] “It will leave patients and others wondering” why $475,000 is the right price “instead of 175 [thousand], 600, 750 or any other number,” Dr. Pearson said. “And questions will remain about how this price will affect patients’ ability to access the drug, and how it will be used to set a benchmark for other uses of this drug and perhaps other cancer drugs in the future.”
ASH President Comments on FDA Approval of First CART-Cell Therapy to Treat Childhood Leukemia [ASH] “While the importance of CAR-T cannot be overstated, this approval only pertains to a small population of children."
FDA Approves First CAR-T Cell Therapy for Pediatric Acute Lymphoblastic Leukemia [NIH Director's Blog] Immunotherapy is indeed the achievement of many minds. At the same time, the commitment and passion of researchers such as June and Rosenberg—and James Allison of the University of Texas MD Anderson Cancer Center, Houston, for checkpoint inhibitors—have been essential to pushing past obstacles and skeptics, and bringing us to this remarkable moment in medicine’s history.
A $475,000 price tag for a new cancer drug: crazy or meh? [STAT] In conjunction with the Centers for Medicare and Medicaid Services, Novartis announced that it will be entering the market in a manner that its next approved indication for Kymriah may have a different price from the $475,000 announced on Wednesday.
Novartis receives first ever FDA approval for a CAR-T cell therapy, Kymriah(TM) (CTL019), for children and young adults with B-cell ALL that is refractory or has relapsed at least twice [Novartis] Novel approach to cancer treatment is the result of pioneering CAR-T cell therapy collaboration with University of Pennsylvania.
Novartis Wins Historic FDA Nod, Prices CAR-T For Leukemia at $475,000 [Xconomy] “1 month response is not an outcome. 18 (or 24 or 36) [months] free of relapse without allo Tx”—a reference to bone marrow transplant, the only current way to cure this type of leukemia—“should be the reimbursable outcome.”
Novartis crosses FDA finish line with monumental CAR-T leukemia approval [FiercePharma] Of course, plenty of questions remain as CAR-T use is just ramping up, but leaders in the field have made progress with manufacturing and logistical problems lately, as well as safety, which previously plagued Juno Therapeutics.
FDA Approves CAR T-cell Therapy for Pediatric Acute Lymphoblastic Leukemia [ACS] The FDA based its approval on a small clinical trial of 63 young people with B-cell precursor ALL who had run out of all other options for treatment. The overall remission rate within 3 months of treatment was 83%.
FDA Approves Novartis Treatment That Alters Patients Cells To Fight Cancer [Forbes] Novartis bought the rights to the Penn treatment for just $20 million up front. "I've told the team that resources are not an issue. Speed is the issue," says Novartis' Chief Executive Joseph Jimenez, told Forbes in a cover story about the work then.
US approves first cancer drug to use patient's own cells – with $475,000 price tag [The Guardian] Though the price may be shocking to many, analysts will probably view the $475,000 price tag as conservative. A British study suggested the “upper bound” for a drug like Kymriah could be $649,000.
Modified T cells that attack leukemia become first gene therapy approved in the United States [Science] The FDA decision was expected after an agency advisory panel met in July to discuss the risks and benefits of the Novartis treatment. Panelists raised some safety concerns, but voted unanimously to recommend approval.
Novartis CEO's Dilemma: Is $475,000 Too Much For A Leukemia Breakthrough? Or Is It Not Enough? [Forbes] It’s conceivable that later on other CAR-T’s could be worth more – Jimenez points to promising data combining Novartis’ technology with AbbVie’s cancer drug Imbruvica. But it’s also possible they could be worth less.
FDA ushers in a new era in cancer treatment with ‘historic’ CAR-T approval for Novartis [EndPoints] It’s a big day in the biotech world, but it’s just the official start date for a new era.
The FDA Has Approved the First ‘Gene Therapy’ for Cancer [MIT Technology Review] Kymriah will initially be available at 20 U.S. hospitals within a month, Novartis says. Eventually, 32 total sites will offer the therapy.
F.D.A. Approves First Gene-Altering Leukemia Treatment, Costing $475,000 [NY Times] Because Kymriah can have life-threatening side effects, including dangerous drops in blood pressure, the F.D.A. is requiring that hospitals and doctors be specially trained and certified to administer it, and that they stock a certain drug needed to quell severe reactions.
FDA approval brings first gene therapy to the United States [FDA] CAR T-cell therapy approved to treat certain children and young adults with B-cell acute lymphoblastic leukemia.
	5.2.2 Pharma - Fusions & Acquisitions
Juno, bluebird In Focus as Targets Following Gilead-Kite Aquisition [The Street] The transaction is a "boon for the cell therapy space in general" and "heralds big biotech's view regarding the promise of cell therapy, opening the door for more favorable deals going forward as companies evaluate how to position themselves in the oncology space."
	5.6 ESMO
Bristol-Myers Squibb Data at ESMO 2017 Demonstrate Company’s Innovative Research Approach to Treating Cancer from All Angles [BMS] Long-term survival and safety data to be presented for Opdivo in advanced melanoma, non-small cell lung cancer and head and neck cancer.
Clovis Oncology to Present Comprehensive Dataset from Successful ARIAL3 Clinical Trial Program at 2017 ESMO Congress [Clovis] Comprehensive results from Phase 3 ARIEL3 maintenance treatment trial of rucaparib in advanced ovarian cancer patients accepted as late-breaker presentation, will be highlighted in ESMO press program.
	5.6.4 ESMO - Poumon
ESMO 2017 Press Release: IFCT-0302 results question role of CT-scan in NSCLC post-surgery follow-up [ESMO] The findings suggest regular CT scans, which many guidelines recommend, may not be necessary.
AstraZeneca highlights latest advances in lung cancer at the ESMO 2017 Congress [AstraZeneca] More than 40 presentations, including data from two pivotal trials selected as late-breaking abstracts for oral presentation in the ESMO Presidential Symposia.
	6.1 Observation
Publishing national chemotherapy data has helped NHS hospitals make changes that should improve treatment [Cancer Research UK] The new information has already changed how some hospitals manage and review chemotherapy treatment. But this is just the beginning. Public Health England is now exploring other ways of using data to help improve patient outcomes.
	6.7 DMP, Big Data & applis
UK needs to act urgently to secure NHS data for British public, report warns [The Guardian] Sir John Bell, a professor of medicine at Oxford university who led the government-commissioned review, said that NHS patient records are uniquely suited for driving the development of powerful algorithms that could transform healthcare and seed an “entirely new industry” in AI-based diagnostics.
	6.9 Controverses
In a Sign of Gene-Editing Frenzy, Startup Pitches Editing without CRISPR [MIT Technology Review] “What’s surprising is this company raised so much money on something thought to be untrue in the scientific community,” says David Russell, a researcher at the University of Washington, in Seattle.