Clinical benefit and regulatory outcomes of cancer drugs receiving accelerated approval

JAMA

2024-04-07

(Press-News.org) About The Study: Most cancer drugs granted accelerated approval did not demonstrate benefit in overall survival or quality of life within five years of accelerated approval. Patients should be clearly informed about the cancer drugs that use the accelerated approval pathway and do not end up showing benefits in patient-centered clinical outcomes.

Authors: Aaron S. Kesselheim, M.D., J.D., M.P.H., of Brigham and Women’s Hospital and Harvard Medical School in Boston, is the corresponding author.

To access the embargoed study: Visit our For The Media website at this link https://media.jamanetwork.com/

(doi:10.1001/jama.2024.2396)

Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, conflict of interest and financial disclosures, and funding and support.

# # #

Media advisory: This study is being released to coincide with presentation at the American Association for Cancer Research Annual Meeting 2024.

Embed this link to provide your readers free access to the full-text article This link will be live at the embargo time https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2024.2396?guestAccessKey=15ee7076-4bec-43b0-8c24-bb84c7c24bdc&utm_source=For_The_Media&utm_medium=referral&utm_campaign=ftm_links&utm_content=tfl&utm_term=040724

END

ELSE PRESS RELEASES FROM THIS DATE:

Remote care approach improved therapy adherence and uptake in patients with type 2 diabetes

2024-04-07

KEY TAKEAWAYS Researchers at Mass General Brigham tested a remote patient education and navigation program with 200 patients who had type 2 diabetes and elevated cardiovascular/kidney risk. Patients who received education simultaneously with treatment were more likely to begin and adhere to treatment while a period of education prior to therapy initiation was inferior for prescription acceptance and therapy uptake. The study highlights the importance of “striking while the iron is hot” and the potential for remote, team-based care to bridge ...

Trial to improve management of common heart rhythm disorder enrols first patient

2024-04-07

Sophia Antipolis, France – 7 April 2024: The first EU-wide trial aiming to improve the care of elderly atrial fibrillation patients with additional chronic health conditions has enrolled its first patient. The EU-funded EHRA-PATHS study is coordinated by the European Society of Cardiology (ESC) and the European Heart Rhythm Association (EHRA) of the ESC. Atrial fibrillation is the most common heart rhythm disorder, affecting more than 40 million individuals worldwide.1 The likelihood of developing the condition increases with age and the number of other conditions such as high blood pressure, ...

Electronic sock detects unhealthy walking style

2024-04-07

Berlin, Germany – 7 April 2024: An electronic sock that detects an unhealthy walking style linked with diabetes and poor circulation shows promise for preventing foot ulcers and amputation. The novel research is set to benefit the many patients with diabetes who have clogged arteries in the legs and is presented for the first time at EHRA 2024, a scientific congress of the European Society of Cardiology (ESC).1 Study author Dr. Ki Hong Lee of Chonnam National University Hospital, Gwangju, Republic of Korea said: “Diabetes can affect the way people walk, also known as their gait. Patients with diabetes tend to put pressure ...

Stopping aspirin one month after coronary stenting procedures significantly reduces bleeding complications in heart attack patients

2024-04-07

Withdrawing aspirin one month after percutaneous coronary intervention (PCI) in high-risk heart patients and keeping them on ticagrelor alone safely improves outcomes and reduces major bleeding by more than half when compared to patients taking aspirin and ticagrelor combined (also known as dual antiplatelet therapy or DAPT), which is the current standard of care. These are the results from the ULTIMATE-DAPT study announced during a late-breaking trial presentation at the American College of Cardiology Scientific ...

Short-term incentives for exercise can lead to sustained increases in activity

2024-04-07

Short-term incentives for exercise can lead to sustained increases in activity NIH-supported study shows certain perks can spur long-term behavior change in adults with cardiovascular disease risks Adults with heart disease risks who received daily reminders or incentives to become more active increased their daily steps by more than 1,500 after a year, and many were still sticking with their new habit six months later, according to a study supported by the National Institutes of Health that published in Circulation. ...

Successful “first in human” clinical trial of pioneering guidance for heart bypass surgery

2024-04-07

A new approach to the guidance, planning and conduct of heart bypass surgery has been successfully tested on patients for the first time in a clinical trial coordinated by a research team at University of Galway. The FAST TRACK CABG study, overseen by the University’s CORRIB Research Centre for Advanced Imaging and Core Lab, has seen heart surgeons plan and carry out coronary artery bypass grafting (CABG), based solely on non-invasive cardiac-CT scan images, with HeartFlow’s AI-powered blood flow analysis of the patient’s coronary arteries. The research was published today in the European Heart Journal and is available at https://academic.oup.com/eurheartj/article-lookup/doi/10.1093/eurheartj/ehae199 The ...

Influenza vaccine immune response in patients with high-risk cardiovascular disease

2024-04-07

About The Study: High-dose influenza vaccine elicited a more robust humoral response in patients with heart failure or prior myocardial infarction enrolled in the INVESTED randomized clinical trial, with no association between seroconversion status and the risk for cardiopulmonary hospitalizations or all-cause mortality. Vaccination to prevent influenza remains critical in high-risk populations. Authors: Scott D. Solomon, M.D., of Brigham and Women’s Hospital and Harvard Medical ...

Plozasiran (ARO-APOC3) for severe hypertriglyceridemia

2024-04-07

About The Study: This randomized clinical trial demonstrates the potential clinical utility of plozasiran, an investigational APOC3-targeted small interfering–RNA drug, to reduce triglyceride level in patients with severe hypertriglyceridemia. Additional studies will be required to determine whether plozasiran favorably modulates the risk of severe hypertriglyceridemia-associated complications. Authors: Daniel Gaudet, M.D., Ph.D., of the Université de Montréal, is the corresponding author. To access the embargoed study: Visit our For The Media website at this link https://media.jamanetwork.com/ (doi:10.1001/jamacardio.2024.0959) Editor’s ...

Experimental drug could further reduce lipids in the blood in high-risk patients

2024-04-07

Hypertriglyceridemia, or high levels of lipids (fats) in the blood, increases the risk of heart attack, stroke and acute pancreatitis. Currently available medications, including statins, ezetimibe, fibrates and prescription omega 3 fatty acids, typically lower triglyceride levels by anywhere from below 10% to up to 40%. These therapies help, but they are not enough to prevent cardiovascular events in everyone. An experimental treatment could further lower triglycerides in the blood, according to a placebo-controlled ...

New evidence links passive smoking with dangerous heart rhythm disorder

2024-04-07

Berlin, Germany – 7 April 2024: Exposure to secondhand smoke – even at small amounts – is linked with greater risk of a serious heart rhythm disorder, according to research presented at EHRA 2024, a scientific congress of the European Society of Cardiology (ESC).1 The likelihood of atrial fibrillation increased as the duration of passive smoking lengthened. “The dangers of secondhand smoke were significant regardless of whether individuals were at home, outdoors, or at work, indicating that exposure universally elevates the risk of atrial ...

Clinical benefit and regulatory outcomes of cancer drugs receiving accelerated approval

ELSE PRESS RELEASES FROM THIS DATE:

LAST 30 PRESS RELEASES: