Onco Actu du 17 novembre 2015

	4. Dépistage, diagnostic et pronostic
France's Mauna Kea eyes surgical technology partnership by end 2015 [Reuters] Cellvizio provides images of cells and helps doctors diagnose cancers of the stomach, oesophagus and bile ducts. Mauna Kea's shares jumped almost 60 percent in a single day after it was approved by the U.S. Food and Drug Administration.
	4.1 Dép., diag. & prono. - Prostate
EMUC15: Study shows prostate cancer screening under age of 55 may be of limited value [EAU] The new information comes from a group of Dutch researchers from Erasmus University, Rotterdam. The group looked at outcomes from 6822 men in the Rotterdam arm of the European Randomized study of Screening for Prostate Cancer (ERSPC).
	4.10 Dép., diag. & prono. - FDA, EMA, NICE,...
Why FDA Should Oversee Laboratory Developed Tests [FDA] Today FDA is issuing a report that illustrates the real and potential harms to patients and to public health from certain laboratory developed tests (LDTs) – tests that are designed, manufactured and used in a single laboratory.
	5. Traitements
Research points to why some colorectal cancers recur after treatment [MD Anderson Cancer Center] MD Anderson study sheds new light on monoclonal antibody therapy cetuximab.
Q&A With Raymond DuBois, MD, PhD, on Colorectal Cancer Prevention and Treatment [CANCER RESEARCH Catalyst] We asked Raymond DuBois, MD, PhD, executive director of The Biodesign Institute at Arizona State University, and president and chairman of the AACR Foundation, to share with us his thoughts on just how far we have come with preventing and treating colorectal cancers, and what more needs to be done.
	5.10 Traitements - Essais
Gilead’s Zydelig® Combined with Bendamustine and Rituximab Shows Superior Efficacy to Bendamustine/Rituximab in Phase 3 Study of Patients with Relapsed Chronic Lymphocytic Leukemia [Gilead] The DMC recommendation is based upon a predefined interim analysis indicating a statistically significant benefit in efficacy for progression-free survival (PFS) and overall survival (OS) in patients receiving Zydelig plus bendamustine and rituximab, compared to those receiving only bendamustine and rituximab.
	5.2 Pharma
U.S. Food and Drug Administration Accepts for Priority Review the Supplemental Biologics License Application for Opdivo (nivolumab) in Patients with Advanced Renal Cell Carcinoma [BMS] Submission based on overall survival data from CheckMate -025, a Phase 3 study comparing Opdivo versus everolimus in this patient population.
	5.2.3 Pharma - économie
Clovis Blowup Conjures Bad Biotech Memories of ImClone Darkness [TheStreet] For those too young to remember, ImClone, in 2001, was cruising towards FDA approval of its targeted colon cancer drug Erbitux. Investors loved the stock. But the feel-good story ended abruptly in late December of that year when the U.S. Food and Drug Administration rejected Erbitux, citing ImClone's failure to provide adequate documentation of the drug's response rate in a pivotal clinical trial.
Clovis shares dive as FDA asks for more data on lung cancer drug [Reuters] Analysts had expected Clovis's drug, rociletinib, would be approved after a similar treatment from AstraZeneca Plc was approved on Friday, three months ahead of the expected date.
	5.3.4 Traitements - AMM (FDA, EMA)
J&J nabs an early OK for 'breakthrough' multiple myeloma blockbuster contender Darzalex [FierceBiotech] Daratumumab has excited a range of analysts happy to roll out multibillion-dollar projections for this drug.
DARZALEX® (daratumumab) Approved by U.S. FDA: First Human Anti-CD38 Monoclonal Antibody Available for the Treatment of Multiple Myeloma [Johnson & Johnson] DARZALEX is the first human anti-CD38 monoclonal antibody (mAb) approved anywhere in the world.
FDA approves Darzalex for patients with previously treated multiple myeloma [FDA] Darzalex injection, given as an infusion, is a monoclonal antibody that works by helping certain cells in the immune system attack cancer cells.
FDA approves J&J drug for advanced multiple myeloma [Reuters] In one 106-patient study, tumors shrank or were no longer detectable in 29 percent of patients taking Darzalex, and the benefit lasted for an average of 7.4 months. In a second trial, involving 42 patients, 36 percent of patients taking the J&J/Genmab drug saw a partial or complete reduction in tumors.
	5.4 Traitements - Economie
Breast cancer drug Kadcyla 'too expensive' for NHS [BBC News] Women in England will be able to get Kadcyla through the Cancer Drugs Fund, but the price tag per patient - £90,000 at full cost - is too high to widen access, say the draft NICE guidelines.
Postcode lottery for cancer drug as Nice rules Kadcyla too expensive [The Guardian] Effective new cancer drugs ‘held just out of reach’ of patients in Wales and Scotland, says cancer charity, after Roche cut deal with special fund in England.
Roche breast cancer drug at center of UK pricing row [Reuters] Kadcyla has become a test case for drug access in Europe, where NICE has taken a lead in assessing the cost-effectiveness of new medicines by weighing the benefits they offer against a standard benchmark.
	5.7.1 SABCS-communiqués
Puma Biotechnology to Present Data at the San Antonio Breast Cancer Symposium [Puma Biotechnology] The Company is initially focused on the development of PB272 (oral neratinib), a potent irreversible tyrosine kinase inhibitor, for the treatment of patients with HER2-positive breast cancer and patients with non-small cell lung cancer, breast cancer and other solid tumors that have a HER2 mutation.
Genomic Health Announces Presentation of Eight Oncotype DX® Studies at the 2015 CTRC-AACR San Antonio Breast Cancer Symposium [Genomic Health] New "Big Data" SEER Study Establishes Oncotype DX as the Only Multi-gene Breast Cancer Test with Prospective Outcomes Data in Tens of Thousands of Patients.
	6.10 Politiques
Former Health Secretary Andrew Lansley takes on Roche advisory role [Pharmafile] Former UK health secretary Andrew Lansley has taken on work as an advisor to Roche in the midst of ongoing controversy over drug pricing and the future of the Cancer Drugs Fund.
	6.7 DMP, Big Data & applis
Survey Shows Consumers Unlikely to Share Data with Tech Companies [MIT Technology Review] A survey finds that consumers are not eager to give health information to Google, Apple, or Microsoft, but Facebook fared worst of all.