Onco Actu du 26 février 2018

	1. Biologie
How Cells Pack Tangled DNA Into Neat Chromosomes [Wired] For the first time, researchers can see how proteins grab loops of DNA and bundle them for cell division. The discovery also hints at how the genome folds to regulate gene expression.
	3.1.1 Prévention - Tabac - e-cigs
Nick Hopkinson: Making sense of e-cigarettes—Public Health England’s review of the evidence [BMJ] Many healthcare professionals are naturally suspicious about how e-cigarettes will be used, but evidence to date suggests that these fears are unfounded. The PHE report provides a clear road map, with the evidence needed to advise smokers and policy makers.
	4.10 Dép., diag. & prono. - FDA, EMA, NICE,...
FDA Publishes Final Rule and Guidance on Acceptance of Clinical Data to Support Medical Device Applications and Submissions [FDA Law Blog] Overall, the new rule seeks to provide a consistent approach to acceptance of clinical data, regardless of whether the data were collected inside or outside the United States (OUS). To this end, however, the amendments mostly affect the requirements for clinical investigations conducted OUS.
A New Regulatory Threat to Cancer Patients [Wall Street Journal] Washington may impose needless limits on genetic testing.
	5. Traitements
Reducing Overtreatment of Cancer With Precision Medicine [JAMA] Even though patients contribute to the potential for overtreatment, clinicians are ultimately responsible for addressing it during clinical encounters. The paradox of precision medicine is that as clinical algorithms become more precise, they become more complex for physicians and patients.
	5.10 Traitements - Essais
Precision drug could treat different cancers with rare gene fault [Cancer Research UK] The innovative approach, published in the New England Journal of Medicine, involved 55 patients with 17 different types of cancer. Everyone in the trial had a gene fault called a TRK fusion, which occurs in less than 1 in 100 tumours and can fuel growing cancer cells.
EQUATOR-Oncology: reducing the latitude of cancer trial design and reporting [British Journal of Cancer] While initially the focus of EQUATOR-Oncology has been on reporting standards for oncology clinical trials based on core domains common to all types of clinical trials, the next phase will include guidance for efficient research planning and design.
	5.2 Pharma
Merck’s melanoma drug shows early promise for resistant cancers in PhI tria [EndPoints] The treatment, called MK-8353, was tested in patients with melanoma and other cancers with mutations in the BRAF or RAS genes. The drug was designed to block the ERK signal, which has been shown to help drive cancer cell growth in resistant melanoma and other diseases.
	5.3 Traitements - FDA, EMA, NICE...
FDA Expands Use of Durvalumab to Non–small Cell Lung Cancer [Cancer Research Catalyst] Durvalumab is one of five immunotherapeutics that target the PD-1/PD-L1 braking system to have been approved by the FDA for treating a range of cancer types.
	5.3.4 Traitements - AMM (FDA, EMA,...)
Pfizer Announces Update on European Marketing Authorization Application for SUTENT® (sunitinib) in Adult Patients at High Risk of Recurrent Renal Cell Carcinoma [Pfizer] In the U.S., SUTENT is approved for the adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy.
Puma Biotechnology Receives Results of CHMP Formal Decision for Neratinib for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer [Puma] The CHMP has noted that Puma may request a re-examination of the opinion and that a letter of intent to seek re-examination should be submitted within 15 days of acknowledgement of receipt of the final opinion package. Puma plans to submit this request in accordance with this timeline.
Amgen Receives Positive Opinion Expanding Use Of XGEVA® (denosumab) To Cover Prevention Of Skeletal-Related Events In Patients With Multiple Myeloma In Europe [Amgen] Application Based on Data From Largest International Multiple Myeloma Trial for the Prevention of Skeletal-Related Events Ever Conducted.
Pfizer Receives Positive CHMP Opinion for Two Hematology Medicines, MYLOTARG™ and BOSULIF® [Pfizer] MYLOTARG (gemtuzumab ozogamicin) Granted a Positive Opinion for the Treatment of Previously Untreated, De Novo, CD33-positive Acute Myeloid Leukemia in Combination with Chemotherapy. BOSULIF (bosutinib) Granted a Positive Opinion for the Treatment of Newly Diagnosed Ph+ Chronic Myelogenous Leukemia.
Lynparza receives positive EU CHMP opinion in platinum-sensitive relapsed ovarian cancer [AstraZeneca] The CHMP recommendation is based on two randomised trials, SOLO-2 and Study 19, which showed Lynparza reduced the risk of disease progression or death for platinum-sensitive relapsed patients compared to placebo.
Hit by an expected EMA rejection, Puma plans to appeal negative opinion on neratinib [EndPoints] The EMA has raised concerns over the clinical relevance of the data coming out of Puma’s PhII and PhIII studies in extended adjuvant early-stage HER2-positive breast cancer. Combined with the evidence of of severe diarrhea linked to the drug, that led to a negative benefit risk assessment.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 February 2018 [EMA] The cancer medicine Mylotarg (gemtuzumab ozogamicin) received a positive opinion for the treatment of acute myeloid leukaemia in patients aged 15 years and above, giving young patients a new treatment option. The CHMP adopted a negative opinion for Nerlynx (neratinib). Nerlynx was expected to be used to treat breast cancer. The CHMP also adopted a negative opinion for an extension of therapeutic indication for Sutent (sunitinib).
EU panel recommends against nod for Puma Biotech's breast cancer drug [Reuters] The EMA said the Committee for Medicinal Products for Human Use (CHMP) considered that while the drug lowered the risk of the cancer returning after initial treatment, it was uncertain the benefit would translate in clinical practice.
	5.4 Traitements - Economie
Three thyroid cancer drugs approved for NHS in England [Cancer Research UK] Cabozantinib was recommended for treating medullary thyroid cancer that is inoperable or has spread. Around 80 patients are diagnosed with the disease in England each year. Lenvatinib and sorafenib were approved to treat differentiated thyroid cancers, the most common type, if surgery or radioactive iodine therapy don’t work. Around 200 patients in England each year could benefit from the two drugs.
	6.1 Observation
Adherence to Follow-up is Low in Adolescent and Young Adult Cancer Survivors [ESMO] Lynda M. Beaupin of the Roswell Park Cancer Institute in Buffalo, USA and colleagues conducted this study of young adult cancer survivors who were treated at the Roswell Park Cancer institution but did not continue follow-up care.
	6.10 Politiques
One of the most powerful science policy jobs in Brussels changes hands [Science] Director-General for Research and Innovation Robert-Jan Smits, is leaving his post. Smits has been named an adviser at the European Political Strategy Centre, the commission’s in-house think tank (where his exact mission is “still to be determined”); he will be succeeded by France’s Jean-Eric Paquet, now deputy secretary-general of the commission, on 1 April.
	6.10.1 Politiques (USA)
The Trump effect: PwC report says the FDA has slammed the brakes on significant new drug regulations [EndPoints] Over the 4-year run of the Obama administration, says the report, the agency issued 132 “economically significant” regulations for the industry as a whole — an average of 33 per year. Under Trump and Gottlieb, that dropped to a low of just 6.
A successful cancer researcher confronts a new challenge: getting elected to Congress [Science] As a clinical oncologist at MD Anderson Cancer Center in Houston, Texas, Jason Westin tries to help his patients cope with their deadly disease by being both honest and upbeat with them. He’s taking the same approach as a first-time candidate for the U.S. Congress.