Onco Actu du 2 juillet 2018

	2. Etiologie
Study Links Time Spent Sitting to Higher Risk of Death from 14 Diseases [ACS] Association independent of moderate-vigorous physical activity levels.
	3.1 Prévention - Tabac
As Australia wins another challenge to tobacco plain packaging, that sound you hear is the dominoes toppling [Croakey] As Chapman has said before, there is bound to be another appeal, or another action, or an action from another angle but, in the meantime it’s worth celebrating Australia’s leadership, and the message that the finding sends to other countries as plain packaging “dominoes” around the world.
	5. Traitements
NExT: Advancing Promising Cancer Therapies from the Lab to Clinical Trials [NCI] Although NCI operates the program, it runs very much like a small pharmaceutical or biotechnology company, working with external investigators and top scientific experts to advance promising or novel therapies from the earliest stages of research to human clinical trials.
	5.12 Immunothérapies
Immunotherapy: hype and hope [Lancet Oncology] Indeed, commercial companies—and some institutions—excel in the promotion of results of individual drugs or techniques, but the research community must continue to design rigorous investigations that ensure the highest level of reliable, high-quality evidence is generated to inform evidence-based cancer treatment that improves care for all patients, not just specifically selected super-responders.
	5.12.2 Immunothérapies - CAR-T, thérapies cellulaires
European CHMP Adopts Positive Opinion for Yescarta® (axicabtagene ciloleucel) for the Treatment of Relapsed or Refractory DLBCL and PMBCL, After Two or More Lines of Systemic Therapy [Gilead] The MAA is supported by data from the ZUMA-1 trial of axicabtagene ciloleucel in adult patients with refractory aggressive NHL.
CAR-T race heads to Europe as Gilead, Novartis drugs score CHMP backing [FiercePharma] To prepare for the European rollout, Gilead recently announced that it's building a CAR-T manufacturing plant at the Amsterdam airport in an effort to cut down on logistics and manufacturing turnaround time. The center will have 300 employees when fully operational, expected in 2020. Novartis, for its part, has an agreement with the Fraunhofer Institute for Cell Therapy and Immunology to process cells in Europe.
Novartis receives positive CHMP opinion for Kymriah® for treating two aggressive blood cancers, marking important medical advance for patients in Europe [Novartis] Marketing Authorization Application (MAA) based on landmark global CAR-T clinical trials ELIANA and JULIET, the only CAR-T registrational trials to include European patients.
CAR-T Immunotherapies May Have a New Player [UC San Diego] Study finds that natural killer cells engineered with chimeric antigen receptors are equally effective and bring different advantages with less toxicity.
Rival Novartis, Gilead CAR-T therapies win European panel recommendation [Reuters] Kymriah is priced at $475,000 in the United States in its original indication for young people up to 25 with ALL, and at $373,000 for DLBCL, which matches Yescarta’s U.S. price. Prices in Europe will likely vary, as the companies reach deals with agencies in individual companies.
First two CAR-T cell medicines recommended for approval in the European Union [EMA] Kymriah and Yescarta are also the first medicines supported through EMA’s PRIority MEdicines (PRIME) scheme to receive positive opinions from the Committee for Medicinal Products for Human Use (CHMP).
	5.12.3 Immunothérapies-combinaisons
Roche 'highly encouraged' by Tecentriq results in breast cancer Patients with triple-negative breast cancer test negative for hormone receptors or HER2, meaning their tumors do not respond to hormone therapy or to therapies like Roche’s $7 billion-per-year blockbuster Herceptin. As a result, there is significant interest in finding new, better ways to tackle this form of the disease.
Phase III IMpassion130 study showed Roche’s Tecentriq plus Abraxane significantly reduced the risk of disease worsening or death in people with metastatic triple negative breast cancer [Roche] Encouraging overall survival (OS) benefit for PD-L1 positive population at interim analysis.
	5.12.6 Immunothérapies - AMM
Bristol-Myers Squibb Receives Positive CHMP Opinion Recommending Approval of Opdivo (nivolumab) for the Adjuvant Treatment of Adult Patients with Melanoma [BMS] First and only PD-1 agent to receive positive CHMP opinion in the adjuvant setting.
Imfinzi approved in Japan for unresectable Stage III non-small cell lung cancer [AstraZeneca] The approval of Imfinzi is based on positive progression-free survival (PFS) data from the Phase III PACIFIC trial in unresectable Stage III NSCLC.
AstraZeneca wins speedy approvals for cancer drugs in Japan [Reuters] Imfinzi was only given a U.S. green light for treating such stage III lung cancer in February and it is still awaiting approval in the European Union. Japan also approved Lynparza, which AstraZeneca markets with Merck & Co, for breast cancer.
	5.3.4 Traitements - AMM (FDA, EMA,...)
Lynparza approved in Japan for BRCA-mutated metastatic breast cancer [AstraZeneca] In the trial, Lynparza significantly prolonged progression-free survival (PFS) compared with chemotherapy, reducing the risk of disease progression or death by 42% (HR 0.58; 95% CI 0.43-0.80; p=0.0009, median PFS was 7.0 months with Lynparza vs 4.2 months with chemotherapy).
Puma Biotechnology Receives Positive CHMP Opinion Recommending Approval of NERLYNX® for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer [Puma] NERLYNX (neratinib) is a kinase inhibitor indicated for the extended adjuvant treatment of adult patients with early-stage HER2 overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.
Puma Biotech gets EU panel nod for breast cancer drug [Reuters] The experimental drug lowers the risk of the disease returning after initial treatment. The U.S. Food and Drug Administration already approved Puma’s drug last year.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 June 2018 [EMA] The CHMP recommended granting a marketing authorisation for Nerlynx (neratinib), for the adjuvant treatment of adult patients with breast cancer, after re-examining its negative opinion for this medicine adopted in February 2018.
	6.6 Publications
35,000 papers may need to be retracted for image doctoring, says new paper [Retraction Watch] The number is large in magnitude but small when compared to the fraction that may be candidates for retraction in the total literature. I think scientists need to be aware that there are problem papers out there and just be cautious with any published information.
	6.7.2 Applis
Why telemedicine has been such a bust so far [CNBC] Telemedicine, or apps that let you consult with a doctor via video, was supposed to be the next big thing in health care. But lack of awareness, questions about cost and reimbursement, and the human desire to talk to another person when sick have hampered the sector. Tech giants like Apple may ride to the rescue.
	6.9 Controverses
Irish woman receives €7.4m over cervical smear cancer scandal [The Guardian] Emma Mhic Mhathúna is one of 209 women who received false negative results in smear tests between 2010 and 2104, errors that only came to light two months ago.