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2. Etiologie
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Association independent of moderate-vigorous physical activity levels.
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3.1 Prévention - Tabac
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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.
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5. Traitements
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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.
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5.12 Immunothérapies
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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.
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5.12.2 Immunothérapies - CAR-T, thérapies cellulaires
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The MAA is supported by data from the ZUMA-1 trial of axicabtagene ciloleucel in adult patients with refractory aggressive NHL.
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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.
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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.
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Study
finds that natural killer cells engineered with chimeric antigen
receptors are equally effective and bring different advantages with less
toxicity.
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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.
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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).
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5.12.3 Immunothérapies-combinaisons
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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.
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Encouraging overall survival (OS) benefit for PD-L1 positive population at interim analysis.
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5.12.6 Immunothérapies - AMM
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First and only PD-1 agent to receive positive CHMP opinion in the adjuvant setting.
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The
approval of Imfinzi is based on positive progression-free survival
(PFS) data from the Phase III PACIFIC trial in unresectable Stage III
NSCLC.
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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.
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5.3.4 Traitements - AMM (FDA, EMA,...)
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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).
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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.
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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.
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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.
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6.6 Publications
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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.
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6.7.2 Applis
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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.
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6.9 Controverses
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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.
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