Onco Actu du 24 novembre 2015

	1. Biologie
‘Drivers’ and ‘Passengers’: who’s in charge? [The Darwin Cancer Blog] Overall, these complications highlight the question of what, when and how mutations, arising by chance, acquire selective currency in cancer clone development. What makes them ‘passengers’ or ‘drivers’? As so often in biology, context is everything.
	2.11 Etiologie - Alimentation
UK bacon and sausages sales hit by cancer link: report [Reuters] IRI said sales of pre-packed sausages on a value basis fell 15.7 percent in the week to Oct. 31 compared with the same week the previous year, while pre-packed bacon sales were down 17 percent.
	5.10 Traitements - Essais
Exelixis Announces Presentation of Positive Overall Survival Results for COTELLIC™ in Combination with Vemurafenib in Advanced BRAF V600 Mutation-Positive Melanoma at Society for Melanoma Research 2015 International Congress [Exelixis] COTELLIC is a selective inhibitor of MEK that was discovered by Exelixis and is now the subject of a worldwide collaboration agreement between Exelixis and Genentech, a member of the Roche Group.
	5.12 Immunothérapies
Roche's blockbuster-hopeful immunotherapy shows promise in skin cancer [FierceBiotech] The whole class of medications is slated to bring in more than $30 billion at its peak, analysts say, a projection that assumes Roche and its rivals will be able to continually demonstrate the value of checkpoint inhibition in more and more cancers, changing the standard of care.
	5.2 Pharma
Genmab Announces Ofatumumab Phase III Study in Follicular Lymphoma to be Stopped Following Planned Interim Analysis [Genmab] The decision to stop the study was made after a planned interim analysis performed by an Independent Data Monitoring Committee (IDMC) showed that it was unlikely that ofatumumab would show superiority if the trial was to be completed as planned.
XBiotech Provides Update on Phase III COncology Study in Europe [XBiotech] The Company found 25 patients dropped off study prior to receiving any dosing with drug or placebo. Analysis of patient blood samples also revealed that 14 patients erroneously received either placebo or study drug. In addition, 33 patients completed the study but failed to receive scheduled DEXA scans, properly complete EORTC evaluation, or both. The Company reports that these combined irregularities compromises data from 72 patients in the study.
	5.2.2 Pharma - Fusions & Acquisitions
Pfizer and Allergan to Combine [Pfizer] Pfizer plc will have its global operational headquarters in New York and its principal executive offices in Ireland.
Pfizer-Allergan [In the Pipeline] I don’t think that the newly merged companies are going to purge the R&D labs. They need them, still, and it’s not like Allergan’s bringing much with them. But that doesn’t mean that things are necessarily going to be great over there, either.
Pfizer-Allergan deal could hurt R&D, increase drug costs [STAT] The type of deal Pfizer is pursuing, which is known as a tax inversion, appears destined to accentuate the downsides.
Merger Math: Is There Anything Left For Pfizer To Cut At Allergan? [Forbes] There’s simply not much to cut because those cuts were announced as part of these other deals. (Pfizer, for its part, has cut 50,000 jobs over the past five years.) This is also likely to irk those who are angry that this deal will move Pfizer’s tax domicile to Ireland, cutting its tax rate fro 25% to 18%.
	5.3.4 Traitements - AMM (FDA, EMA)
FDA approves Opdivo to treat advanced form of kidney cancer [FDA] Those treated with Opdivo lived an average of 25 months after starting treatment compared to 19.6 months in those treated with Afinitor.
BMS racks up another Opdivo approval after FDA makes quick decision [FierceBiotech] After the market closed on November 16, BMS said the FDA had accepted an application for the use of Opdivo as a treatment for patients with advanced RCC who have received prior anti-angiogenic therapy. Almost exactly one week later, FDA revealed it had approved Opdivo for use in the indication.
Two New Therapeutics Approved For Treating Multiple Myeloma [CANCER RESEARCH Catalyst] The flurry of decisions from the U.S. Food and Drug Administration (FDA) on investigational anticancer therapeutics continued last week when the agency approved two new agents for treating certain patients with multiple myeloma: daratumumab (Darzalex) and ixazomib (Ninlaro).
European Medicines Agency Recommends Granting a Marketing Authorisation for Asparaginase and Pegaspargase [ESMO] These medicinal products are intended for the treatment of acute lymphoblastic leukaemia.
FDA Approves Nivolumab for the Treatment of Advanced Renal Cell Cancer [ESMO] By blocking the PD-1/PD-L1 pathway, Opdivo may help the body’s immune system fight cancer cells. Opdivo is intended for use in renal cell carcinoma in patients who have received prior anti-angiogenic therapy.
Bristol-Myers Squibb Announces U.S. Food and Drug Administration Approval for Opdivo (nivolumab) as a Single Agent for the Treatment of Patients with Previously Untreated BRAF Wild-Type Advanced Melanoma [BMS] Approval based on Phase 3 trial, CheckMate -066, which demonstrated superior overall survival vs. dacarbazine in first-line treatment of patients with BRAF wild-type advanced melanoma.
	6.10 Politiques
Health and economic growth will suffer without commitment to science budget says Cancer Research UK [Cancer Research UK] Ahead of the Spending Review this week Cancer Research UK is urging the Government to protect the science budget across Government departments or risk losing improvements in cancer prevention, early diagnosis and survival seen over recent years.