Onco Actu du 27 mai 2019

	2. ETIOLOGIE
‘It’s killing us’: why firefighters are battling to ban flame retardants [The Guardian] Massachusetts has failed to sign a bill banning flame retardants into law despite endorsement of lawmakers and pediatricians and concerns over safety.
	3.5 PRÉVENTION - UV
In rare occasions, dark-skinned people can get skin cancer. But sunscreens won’t help. [Washington Post] For black people, melanoma is not associated with UV exposure and develops in such places as the palms of the hands and soles of the feet.
	4. DÉPISTAGE, DIAGNOSTIC ET PRONOSTIC
Independent review of national cancer screening programmes in England -Interim report of emerging findings: Professor Sir Mike Richards [NHS England] This interim report sets out emerging findings of my review to date. At this early stage, I suggest these are treated as preliminary and share them to form ongoing engagement as my review enters its next phase. I can however already make two clear recommendations.
'Cancer screening should be as easy as booking a flight' [BBC News] Making an appointment for breast and cervical cancer screening should be as simple as booking a plane ticket online, says the man behind an overhaul of the current system in England.
	4.10 DÉP., DIAG. & PRONO. - FDA, EMA, NICE,...
QIAGEN launches first FDA-approved companion diagnostic for PIK3CA biomarkers to enhance precision medicine in breast cancer [Qiagen] Innovative therascreen® PIK3CA RGQ PCR Kit receives U.S. regulatory approval for use in guiding treatment decisions from tissue and liquid biopsy for newly approved therapy PIQRAY® (alpelisib) from Novartis.
	4.12 BIOPSIES LIQUIDES
Multi-Site Study Tests Power of Commercial Reference Materials in Comparing Liquid Biopsy Assays [Genome Web] The speed at which liquid biopsy tests have emerged and entered the clinical market had, for a time, outpaced the creation of reference and quality control materials to help the field assure itself of tests' accuracy and comparability. But efforts have accelerated in the last few years, both among academicians, and commercially, to fill this gap.
	5.12.5 IMMUNOTHÉRAPIES - PHARMA
FLX Bio keeps it capital in RAPT Therapeutics rebrand [Fierce Biotech] “Since our founding, we have internally discovered and advanced two unique drug candidates that target CCR4, with FLX475 in development for the treatment of multiple cancers and RPT193 expected to enter clinical studies in the second half of 2019."
	5.12.8 IMMUNOTHÉRAPIES - ECONOMIE
Dynavax axes immuno-oncology pipeline and 82 staff [Fierce Biotech] Work is underway to wind down the immuno-oncology trials. Dynavax is the sponsor of a phase 1/2 trial that is testing SD-101 in combination with Merck’s Keytruda. And the same drug is being tested in a clutch of trials sponsored by other groups, including QuantumLeap Healthcare Collaborative’s I-SPY 2 trial.
Dynavax cuts staff in retreat from cancer research [Biopharma Dive] Dynavax's planned pivot away from oncology isn't a surprise: Gray announced May 8 the company wouldn't invest in any new research until it found a partner.
Dynavax cuts staff and cancer R&D, focuses on vaccine [Pharmaforum] Its pipeline overiew page shows it had been developing SD-101 in combination with Merck & Co’s Keytruda in early clinical trials, and DV281 in combination with Bristol-Myers Squibb’s rival PD-1 cancer immunotherapy Opdivo.
	5.2 PHARMA
FDA Approves the NovoTTF-100L™ System in Combination with Chemotherapy for the Treatment of Malignant Pleural Mesothelioma [Novocure] NovoTTF-100L, a Tumor Treating Fields delivery system, is the first FDA-approved mesothelioma treatment in more than 15 years.
Novocure bags mesothelioma nod for electric fields cancer therapy with some limitations [EndPoints] The NovoTTF-100L System is to be deployed with Eli Lilly’s Alimta (pemetrexed) and a platinum-based chemotherapy in the first-line treatment of unresectable, locally advanced or metastatic forms of the disease.
	5.2.3 PHARMA - ÉCONOMIE
Mass exodus of Amgen sales reps sparks legal battle with multiple myeloma rival Karyopharm [Fierce Pharma] Those 19 salespeople resigned from Amgen last year to join Karyopharm, which is preparing to launch selinexor, a multiple myeloma drug that will compete directly with Amgen’s Kyprolis. Now Amgen is suing Karyopharm, alleging that it stole trade secrets about the performance of its salesforce and used the information to hire away its best reps.
Ideaya wraps $50M IPO to fuel clinical drive on synthetic lethality [EndPoints] The plan is to take the drug, a PKC inhibitor for cancers with GNAQ and GNA11 mutations, straight into a basket study in solid tumors, then follow that with a slate of preclinical programs composing what Hata sees as the most “diverse portfolio” in the precision medicine field.
	5.3.4 TRAITEMENTS - AMM (FDA, EMA,...)
Cancer research drives breast cancer treatment forward [Novartis] The Novartis team synthesized and studied approximately 600 compounds that inhibited PI3K-alpha before homing in on one potential drug candidate.
FDA approves Novartis Piqray® - the first and only treatment specifically for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer [Novartis] Piqray was the first new drug application approved under the FDA Oncology Center of Excellence Real-Time Oncology Review pilot program.
FDA approves first PI3K inhibitor for breast cancer [FDA] Today, the U.S. Food and Drug Administration approved Piqray (alpelisib) tablets, to be used in combination with the FDA-approved endocrine therapy fulvestrant, to treat postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer (as detected by an FDA-approved test) following progression on or after an endocrine-based regimen.
Make that 2 prospective blockbuster approvals in 1 day for Novartis as FDA OKs targeted cancer therapy [EndPoints] Alpelisib, initially code-named BYL719, will now hit the market as Piqray. It won’t come cheap. The drug will be sold at a wholesale acquisition price of $15,500 a month, or right around $200,000 a year.
Novartis' breast cancer treatment wins FDA approval [Reuters] The drug, alpelisib, to be marketed under the brand name Piqray, belongs to a class of drugs known as PI3K inhibitors and is the first of its kind to be approved, the FDA said in a statement.
	5.4 TRAITEMENTS - ECONOMIE
Novartis slaps $2M-plus price tag on newly approved gene therapy Zolgensma—and cost watchdogs approve [Fierce Pharma] Last month, its analysis said Zolgensma wouldn’t be cost effective with a price tag higher than $1.5 million. Now, thanks to some new data and value-based payment plans, ICER says it's worth up to $2.1 million.
At $2.1 million, newly approved Novartis gene therapy will be world’s most expensive drug [STAT] Novartis is likely to face backlash from critics who believe charging millions of dollars for any medicine — no matter how effective — renders it unaffordable for a healthcare system already under financial stress.
	6.11 PATIENTS
‘I was a 31-year-old kid in a way’: How a cancer diagnosis changed a health care reporter [STAT] Aside from just dealing with the administrative nightmare that is cancer, dealing with the ethical hula hoops is also, I think, the worst part … but also kind of interesting.
	6.4 MÉDICO-ÉCO
Measuring Financial Toxicity After Cancer Diagnosis and Treatment [ESMO] Available instruments may not be capable of ascertaining all relevant domains.
	6.9 CONTROVERSES
NHS bosses accused of breaking law in cancer scanning privatisation [The Guardian] Oxfordshire councillors have warned that cancer patients in Thames Valley will receive a poorer service because NHS England has decided to take a contract for PET-CT scanning away from Oxford university hospitals (OUH) trust and hand it to the private firm InHealth.