Onco Actu du 21 février 2017

	1. Biologie
Step by Step: Stem Cell Approach Provides New Models for Studying How Acute Myeloid Leukemia Progresses [Memorial Sloan Kettering] This is the first time researchers have been able to replicate each stage of the disease.
	5. Traitements
Claims that ‘putting people in to hibernation’ will help cure cancers aren’t backed up by evidence [Cancer Research UK] Humans don’t naturally hibernate, and so far the only non-hibernating animal that researchers have successfully made to hibernate is the rat. They did this by using drugs to switch off a particular set of signals in the brain. Humans are much larger and more complex than rats, so it’s unknown if that technique would work in people, or more importantly whether it would be safe.
	5.12.2 Immunothérapies - CAR-T
Critics of experimental cancer therapy just don’t get it [STAT] Zach experienced horrendous side effects from his chemotherapy, died from treatment-related complications, and the cost was astronomical — but all of this was with “standard” cancer therapy. In my view, the critics of CAR-T therapy are taking a myopic view of this incredibly powerful and exciting form of cancer treatment, one that holds great hope for desperate patients and their families.
	5.2.2 Pharma - Fusions & Acquisitions
Nordic Nanovector sees interest in its Non-Hodgkin Lymphoma treatment [Reuters] Nanovector is currently preparing a final test phase for its Betalutin drug candidate, a treatment for Non-Hodgkin Lymphoma (NHL) designed to attach itself to tumors in a novel way before killing them with a dose of radiation.
	5.3 Traitements - FDA, EMA, NICE...
Transparency Push: EMA to Revise Policy on Document Access [RAPS] EMA is now seeking comments until 18 May on a revision that says: “The information proactively published will be increased with the introduction of proactive publication of clinical data for medicinal products for human use (EMA Policy/0070) and with the coming into force of other relevant legislative provisions.”
Do President Trump’s Regulatory Freeze-Out and “1-in-2-Out” Orders Affect the Regulation of Compounding? [FDA Law Blog] Notwithstanding this analysis, we likely will need to take a “wait and see” approach concerning FDA’s development of finalization of guidance and regulations addressing compounding under Sections 503A and 503B.
FDA Accepts Two sBLAs for Pembrolizumab for Locally Advanced or Metastatic Urothelial Cancer in Cisplatin-Ineligible First-Line and Second-Line Post-Platinum Failure Treatment Settings [ESMO] Pembrolizumab also receives Breakthrough Therapy Designation for second-line treatment based on KEYNOTE-045.
Company-funded studies of approved drugs may not catch safety issues [Reuters] Even if these so-called post-marketing studies do uncover previously undetected adverse events, physicians conducting the trials are often required to keep results confidential, limiting the potential for regulators or patients to learn about safety issues, according to the study in The BMJ.
	5.3.4 Traitements - AMM (FDA, EMA)
Roche receives EU approval of Alecensa (alectinib) for people with previously treated ALK-positive non-small cell lung cancer [Roche] The conditional approval is based primarily on data from the pivotal phase II NP28673 and NP28761 studies, which showed that Alecensa shrank tumours in up to 52.2% (95% CI: 39.7%, 64.6%) of people with advanced ALK-positive NSCLC whose disease had progressed following treatment with crizotinib (overall response rate; ORR).
	5.4 Traitements - Economie
Innovations in Cancer Care: Capturing What Patients Value in the Calculus of Drug Costs [Precision Health Economics] Learn about PHE’s groundbreaking studies that have helped define the value of new oncology drugs, and why a variety of global stakeholders have turned to PHE to assist them in defining value in cancer care.
Generic version of top-selling lung cancer drug hits Chinese market [Pharmafile] A generic version of AstraZeneca’s Iressa (gefitinib) has been released onto the Chinese market, named Yiruike. The generic undercuts the price of Iressa drastically, with Iressa now being 5 times more expensive, and offers to extend the lifesaving medication to those in need who previously could not the cost of AstraZeneca's drug.
People with Cancer History More Likely to Change Prescriptions to Save Money [ACS] The increasing number of expensive, patient-administrated, oral antineoplastic agents may increase the likelihood that patients with cancer may delay, skip, or even forgo their prescription medications for financial reasons.
	6. Lutte contre les cancers
The Importance of Pediatric Drug Development: A Conversation with Pr. Gilles Vassal, Dr. Gregory Reaman, and Mr. Raymond Rodriguez-Torres [Friends of Cancer Research] Due to the need for studying pediatric cancers and developing treatments, Friends of Cancer Research (Friends) is holding a forum focusing on the acceleration of pediatric drug development.
	6.1 Observation
Macmillan warns of cancer 'survival gap' in Scotland [BBC News] Analysis of survival rates for six common cancers found wide variations depending on where patients lived. Macmillan Cancer Support said there needed to be a major step-up in cancer screening in deprived areas.
	6.7 DMP, Big Data & applis
Sanger Institute's COSMIC database expands cancer cloud capabilities at the Institute for Systems Biology [Sanger Institute] The Institute for Systems Biology has embedded the COSMIC data within their Cancer Genomics Cloud (CGC), which is a cloud-based platform that uses Google BigQuery technology to bring unprecedented computing power to researchers around the world.
An IBM-Watson Collaboration Goes Under [In the Pipeline] It’s worth noting that there was good press about this effort along the way, with stories about how well the software was doing at diagnosis, etc. Something to consider when you come across stories written in the same vein, for sure. Wait until the project delivers before making it down as a success. . .