mardi 30 juin 2020

Onco Actu du 30 juin 2020

Message de service : ce billet est le dernier numéro d'Onco Actu rédigé par son créateur. Fidèles lecteurs, sachez que je pars à la retraite fier d'avoir contribué, durant toutes ces années, à la lutte contre les cancers en France.
Gérard Chevalier

Why the ban on nicotine vape fluid will do more harm than good [The Conversation] 
Last week the federal government’s Office of Drug Control announced changes to the importation of nicotine-containing electronic cigarette fluids that will seriously affect the estimated 227,000 regular e-cigarette users in Australia.

Yale Cancer Center Study Validates Combination Therapy for Aggressive Endometrial Cancer [Yale] 
Yale Cancer Center (YCC) scientists have found that combining the targeted drug trastuzumab with chemotherapy significantly improves survival rates for women with a rare, aggressive form of endometrial cancer. These results may help to change the standard of care worldwide for the disease. The findings are published today in the journal Clinical Cancer Research.

FDA Approves First-Line Immunotherapy for Patients with MSI-H/dMMR Metastatic Colorectal Cancer [FDA] 
The FDA’s approval for this indication was based on the results of one multicenter, international, open-label, active-controlled, randomized trial that compared Keytruda with chemotherapy treatment in 307 patients with MSI-H or dMMR metastatic colorectal cancer.

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for First-Line Treatment of Patients With Unresectable or Metastatic MSI-H or dMMR Colorectal Cancer [Merck] 
Approval Received Less Than One Month Following Submission of sBLA Application Based on Results of KEYNOTE-177.

Engineered immune cells recognize, attack human and mouse solid-tumor cancer cells [University of Illinois] 
“We realized that because this receptor binds both to the protein and the sugar on the surface of the cancer cell, there might be room to change the antibody so that it can bind to more than one protein attached to the short sugar,” Sharma said. “This could make it broadly reactive to different kinds of cancers.”

Seattle Genetics Announces Positive Topline Results from Phase 2 Clinical Trial of Tisotumab Vedotin in Recurrent or Metastatic Cervical Cancer [Seattle Genetics] 
Full Data to be Presented at an Upcoming Medical Meeting.

FDA, EMA, ...
What to expect from ‘Modernizing the FDA’s Data Strategy’ meeting [STAT] 
There will also be many implications for the agency when the European Union’s General Data Protection Regulation and other similar regulations come into play. Privacy must be paramount as the data modernization strategy progresses. 

EMA revises methodological guidance for trials impacted by COVID-19 [RAPS] 
The agency also says it will extend its decision to hold all upcoming committee and working party meetings virtually through September 2020. The agency adds that it will continue its practice of holding stakeholder events virtually or postponing them.

FDA Approves Breast Cancer Treatment That Can Be Administered At Home By Health Care Professional [FDA] 
Today, the U.S. Food and Drug Administration approved Phesgo—a combination of pertuzumab, trastuzumab and hyaluronidase–zzxf—for injection under the skin to treat adult patients with HER2-positive breast cancer that has spread to other parts of the body, and for treatment of adult patients with early HER2-positive breast cancer.

FDA approves Roche’s Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) for HER2-positive breast cancer [Roche] 
Data showed that 85% of patients preferred Phesgo compared to standard intravenous administration.

Roche's combo therapy for advanced breast cancer gets U.S. FDA approval [Reuters] 
The therapy, which is initially used in combination with chemotherapy, can continue to be administered at home by a qualified healthcare professional after the patient is finished with the chemotherapy regimen.

Roche Gets FDA OK for Injectable Version of Breast Cancer Drug [Xconomy] 
The newly approved drug, Phesgo, is a fixed-dose mix of pertuzumab (Perjeta) and trastuzumab (Herceptin) that uses technology developed by San Diego’s Halozyme Therapeutics.

Novartis announces MET inhibitor Tabrecta™ approved in Japan for advanced non-small cell lung cancer with METex14 [Novartis] 
Lung cancer is the most common type of cancer in Japan and approximately 3,000 patients are diagnosed with METex14 metastatic NSCLC, a particularly aggressive form of the disease, in Japan each year.

NICE knocks back Janssen's Zytiga combo for newly diagnosed, hormone-sensitive metastatic prostate cancer [Pharmafile] 
This is despite trial data supplied in support of the NICE application showing that patients receiving the Zytiga combo survived for a median of 53.3 months overall, compared to 36.5 months with placebo plus ADT.

Responding to Coronavirus, Cancer Researchers Reimagine Clinical Trials [NCI] 
A greater use of telemedicine has emerged as one of the positive changes to cancer clinical trials that could be continued after the pandemic has passed, according to the results of two surveys of clinical trial investigators and a series of recent commentaries by leaders of clinical trials. 

Scotland's lifeline cancer trials must be restarted urgently [Cancer Research UK] 
A report to the Scottish Parliament’s Cross Party Group on Cancer, which meets online today, has also highlighted a 95% drop* in new patients entering clinical trials, which has left people with cancer with fewer options for treatment. Coronavirus has also delayed research into drugs that could potentially be effective in the future.