Onco Actu du 18 septembre 2017

	2. Etiologie
Tattoo ink particles can spread into lymph nodes [NHS Choices] If you already have a tattoo, there's nothing in this study that should alarm you. It doesn't show that people with tattoos are more likely to get cancer, despite the scaremongering headlines.
	3.1 Prévention - Tabac
American Cancer Society Statement on Philip Morris International Support of New Effort [ACS] "This attempt by Philip Morris International to paint itself as a public health partner is manipulative and dangerous. It is a new twist out of the tobacco industry’s deadly playbook, but nobody should be fooled."
	4.7 Dép., diag. & prono. - Col de l'utérus
FDA Finalizes HPV Diagnostic Study Guidance [RAPS] The newly finalized guidance provides recommendations for the studies needed to support the approval of both standalone HPV tests and ones used in conjunction with pap tests.
	5. Traitements
Tumour bacteria sabotage chemotherapy by destroying cancer drugs [New Scientist] After analysing 113 samples of pancreatic cancer tissue, they found 86 were infected with types of bacteria that could make the long form of the enzyme. These included very common bacteria such as E. coli and salmonella.
	5.12.1 Immunothérapies - partenariats
Bristol-Myers Squibb and Halozyme Enter Global Collaboration and License Agreement for ENHANZE Technology [BMS] The Halozyme ENHANZE technology is based on a proprietary recombinant human hyaluronidase enzyme (rHuPH20) that temporarily degrades hyaluronan -- a glycosaminoglycan or chain of natural sugars in the body -- to aid in the dispersion and absorption of other injected therapeutic drugs.
Bristol To Pay Halozyme $105 Million To Make New Cancer Drugs Easier To Take [Forbes] Medicines like Opdivo must be infused into a vein, an often lengthly process. The Halozyme aims to make it possible to give these drugs as a quick shot under the skin, known as subcutaenous injection.
	5.12.2 Immunothérapies - CAR-T
Mustang ties the knot with Fred Hutch on next-gen CAR-T for lymphoma [EndPoints] This new program comes out of the labs of Oliver Press and Brian Till at the Hutch. They’ve been working on a CAR-T that can express a CD20-specific chimeric antigen receptor.
	5.12.4 Immunothérapies - Essais
FDA adds two Roche studies to its growing list of partial clinical holds in wake of Keytruda deaths [EndPoints] Now Roche’s Phase Ib and a Phase Ib/II in relapsed/refractory multiple myeloma and relapsed/refractory follicular lymphoma will stop enrolling new patients, though the volunteers who have already signed up can continue.
	5.12.7 Immunothérapies - vaccins
Independent Data Monitoring Committee Recommends Discontinuation of Bavarian Nordic's Phase 3 Study of Prostvac in Metastatic Prostate Cancer [Bavarian Nordic] "While this is certainly not the desired outcome, we remain steadfast believers in the power of combination treatments, including immunotherapies, to transform the future of cancer therapies.”
Bavarian Nordic tanks after Bristol-Myers-partnered vaccine flunks phase 3 prostate cancer trial [FierceBiotech] Shares in Bavarian Nordic fell more than 50% following the news, wiping out gains made in 2015 when the Bristol-Myers deal dialed up investor expectations for the therapeutic cancer vaccine.
Biotech's Cancer-Vaccine Insanity [Bloomberg] Despite a bruising legacy of failure, biopharma continues to take expensive shots at this approach to fighting cancer, and investors keep following them off the cliff. The latest victims are investors in Bavarian Nordic A/S.
	5.2 Pharma
Xtandi's new Prosper trial win has Pfizer and Astellas eyeing a bigger market [FiercePharma] Details won’t be available until they’re presented at an upcoming medical conference. But the results were good enough to prompt conversations with regulators about a new approval in all patients with castration-resistant prostate cancer (CPRC).
	5.3.4 Traitements - AMM (FDA, EMA)
Bayer receives FDA approval for Copanlisib in adults with relapsed follicular lymphoma after two prior systemic therapies [Bayer] Developed by Bayer, copanlisib is the only approved PI3K inhibitor with inhibitory activity predominantly against PI3K-alpha and PI3K-delta isoforms expressed in malignant B cells.
FDA approves first biosimilar for the treatment of cancer [FDA] Mvasi, a biosimilar to the cancer drug Avastin, is approved for certain colorectal, lung, brain, kidney and cervical cancers.
TESARO Receives Positive CHMP Opinion for ZEJULA® [Tesaro] The ZEJULA marketing authorization application is supported by data from the ENGOT-OV16/NOVA trial, a double-blind, placebo-controlled, international Phase 3 study of ZEJULA that enrolled 553 patients with recurrent ovarian cancer who had achieved either a PR or CR to their most recent platinum-based chemotherapy.
Bayer gears up to take on Gilead in lymphoma with Aliqopa green light [FiercePharma] The launch, meanwhile, will mark Bayer’s first foray into blood cancer, and it’s prepared accordingly. The company has hired hematology experts to staff its sales force and medical organization, Lacaze said, adding that Bayer wants to roll out Aliqopa “from an ownership standpoint.”
Tesaro earns CHMP thumbs-up for Zejula as three-way PARP race heats up [FiercePharma] Sales of Zejula came in at $26 million for the quarter. Analysts are predicting the drug’s sales will grow to $1.9 billion annually by 2022.
FDA approves new treatment for adults with relapsed follicular lymphoma [FDA] Today’s approval of Aliqopa was based on data from a single-arm trial that included 104 patients with follicular B-cell non-Hodgkin lymphoma who had relapsed disease following at least two prior treatments.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11 to 14 September 2017 [EMA] The CHMP recommended granting marketing authorisations for two cancer medicines: Zejula (niraparib), an orphan designated medicine intended for the treatment of ovarian cancer, and Tookad (padeliporfin), for the treatment of adenocarcinoma of the prostate.
U.S. FDA approves Bayer drug to treat follicular lymphoma [Reuters] The FDA granted Aliqopa accelerated approval, meaning clinical data suggests it will be beneficial, but further trials will be needed to prove that. In a trial of 104 patients, 59 percent experienced a complete or partial shrinkage of their tumors for a median 12.2 months.
U.S. FDA approves biosimilar version of cancer drug Avastin [Reuters] Biologics are made from living cells and are therefore difficult to copy with precision. They are called biosimilars, not generics.
Bayer boosted as FDA OKs its PI3K drug Aliqopa for relapsed follicular lymphoma patients [EdPoints] Bayer has some limited ambitions here, saying earlier that it expects to rack up about $600 million a year, in line with analysts estimates for its peak sales potential.
FDA Approves Olaparib as Maintenance Therapy for Recurrent Ovarian Cancer [NCI] Although the SOLO-2 results showed a “marked delay of tumor progression,” Dr. Kohn said, it’s too early to know whether the maintenance treatment helps patients live longer.
Tesaro's ovarian cancer drug gets EU agency backing [Reuters] The recommendation comes months after the drug’s approval and launch in the United States, where it is sold at a list price of $9,833 for a one-month supply and is marketed as Zejula.
	5.4 Traitements - Economie
Perspectives on Cancer Drug Development Costs in JAMA [Harvard - Bill of Health] It is time for much greater transparency of R&D costs, in as many areas as possible. We should know what companies are spending money on, by disease and product, by stage of development, and on each trial.
	6. Lutte contre les cancers
The Week My Husband Left And My House Was Burgled I Secured A Grant To Begin The Project That Became BRCA1 [Huffington Post] Emily and I went to Washington, DC. The interview went fine. I got the grant, and that was the beginning of the work that now, 33 years later, has become the story of inherited breast cancer and the beginning of the project that became BRCA1.
Living With Cancer: The Crisis in Gynecological Cancer Research [NY Times] According to the Society of Gynecologic Oncology, enrollment in phase 3 National Cancer Institute clinical trials designed for gynecologic cancers declined 90 percent from 2011 to 2016.
	6.1 Observation
Construction of a North American Cancer Survival Index to Measure Progress of Cancer Control Efforts [CDC] We used data from 36 US cancer registries to estimate relative survival ratios for people diagnosed with cancer from 2006 through 2012 to create the CSI.
	6.5 Médecines alternatives
Rigvir: Another unproven and dubious cancer therapy to be avoided [Science-Based Medicine] Rigvir was approved by Latvia in 2004 based on grossly inadequate evidence. The story of Rigvir is the story of an unproven treatment that, because of its origin in a small country, has flown mostly under the radar. Until now, that is.
	6.6 Publications
Peer review in the ORCID community [ORCID] Since the launch of ORCID API 2.0 this February, all ORCID members who have upgraded are able to connect peer review contributions to reviewers' ORCID records.
Project to “fact check” genetic studies leads to three more retractions. And it’s just getting started. [Retraction Watch] Spotting inconsistencies and patterns in articles using automated tools is promising for correcting the literature and preventing problematic articles from being published.
	6.7 DMP, Big Data & applis
Who Will Build the Health-Care Blockchain? [MIT Technology Review] Decentralized databases promise to revolutionize medical records, but not until the health-care industry buys in to the idea and gets to work.
	6.7.3 DMP
With New Software, Epic Aims to Help Patients Share Health Records [Xconomy] Share Everywhere is a new feature within MyChart, Epic’s free, patient-facing software that lets people use computers and mobile devices to do things like view test results, request prescription refills, and securely send written messages to their primary care physicians.