Merck & Co. Seek FDA Approval for Melanoma Drug Keytruda
Merck & Co., Inc. (NYSE:MRK) has announced that it has submitted an application to the U.S. Food and Drug and Administration (FDA) seeking approval for its cancer drug Keytrada that is designed to treat patients with non-small cell lung cancer (NSCLC) after a study comparing the drug against rival cancer treatments by Bristol-Myers Squibb Co. was published yesterday.
The results of the study, which were presented during an American Association for Cancer Research meeting on Sunday and published in the New England Journal of Medicine (NEJM), showed Keytruda to be an effective treatment option for both lung cancer and skin cancer, also called melanoma. The drug proved to be more effective than Bristol-Myers’ melanoma drug Yervoy.
The study evaluated Keytruda against Yervoy, which has been the standard first-line option to treat advanced melanoma since its launch in 2011, in over 830 patients suffering from melanoma which had spread to various parts of their bodies.
Although Keytruda and Yervoy are both immunotherapies, the two drugs function differently. Keytruda (pembrolizumab) is among the new class of cancer drugs called PD-1 inhibitors, which work by blocking Programmed Death receptor (PD-1), the protein which blocks the immune system in cancer patients.
“The treatment paradigm for patients with advanced melanoma should be changed because a PD-1 antibody up front is beneficial,” said Antoni Ribas, professor of oncology at UCLA’s Jonsson Cancer Center, co-author of the NEJM paper, and one of the leaders of the Merck-funded study. “It has a higher response rate and a better safety profile.”
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Keytruda received FDA approval in September 2014, as a treatment for melanoma patients who witnessed worsened condition of their disease after receiving Yervoy. Merck now plans to submit an application with the FDA for approval as a first-line treatment for metastatic melanoma. President of Merck’s research arm, Roger Perlmutter, mentioned that the results from the new study demonstrate Keytruda as “the favored drug” in first-line treatment.
COVID-19 "causing mass trauma among world’s nurses"
Healthcare providers are facing ongoing nursing shortages, and hospitals are reporting high rates of staff turnover and burnout as a result of the COVID-19 pandemic. In June a report found that levels of burnout among staff in England had reached "emergency" levels.
Registered nurses Molly Rindt and Erika Haywood are nurse mentors on US recruitment platform Incredible Health. In this joint Q&A they tell Healthcare Global about their own experiences of burnout and what can be done to tackle it.
What does it mean to be suffering from burnout?
Some of the most common reasons for nurse burnout include long work hours, sleep deprivation, a high-stress work environment, lack of support, and emotional strain from patient care.
While every profession has its stressors, the nursing industry has some of the highest burnout rates. The massive influence on patients’ lives, the long hours, and many other factors put nurses at risk of severe burnout. And with the rise of COVID-19, many healthcare professionals feel the strain more than ever.
Burnout in nurses affects everyone — individual nurses suffer, patients are impacted, and employers struggle with enormous turnover. This is why it’s crucial for healthcare systems and management to watch for signs of nurse burnout and take steps to provide a healthier workplace. Employers should be careful to watch for burnout symptoms in their healthcare staff — and not ignore them.
Symptoms include constant tiredness, constant anxiety related to work, emotional detachment and unexplained sickness.
How widespread is this problem?
Unfortunately, burnout affects approximately 38% of nurses per year and even the WHO recently labelled burnout as an official medical diagnosis. To put this statistic into perspective, nearly 4 out of 10 nurses will drive to work dreading their shift. Burnout is a reason nurses leave their positions.
Other top reasons for leaving included a stressful work environment, lack of good management or leadership, inadequate staffing, and finding better pay or benefits elsewhere.
Even before the pandemic, demanding workloads and aspects of the work environment such as poor staffing ratios, lack of communication between physicians and nurses, and lack of organisational leadership were known to be associated with burnout in nurses.
Have either of you experienced burnout?
Rindt: I have experienced burnout as an RN. I was constantly fatigued, never felt like I was off work, and would frequently dream I was still at work taking care of patients. In my particular situation, I needed to take a step back and restructure my work schedule to allow for more time off. After doing this, I was able to reduce burnout by deciding to work two shifts back-to-back and then have 2-3 days off.
Haywood: I definitely experienced constant anxiety related to work - so much so it would impact the days I wasn’t at work. At one point, I was even on medication to help combat the anxiety and stress I was facing on the job.
I had heart palpitations, chest pain, and wouldn’t be able to sleep before working the next day, which slowly started to impact other aspects of my life. I knew I couldn’t continue to live this way, it wasn’t sustainable. Because of this, I began to focus on my needs and prioritising self-care, especially during the beginning of the pandemic. Putting my needs first and not feeling guilty were necessary for me to overcome burnout.
What impact is COVID-19 having on nurses' wellbeing?
Some nurses have suffered devastating health consequences. Many nurses have dealt with excessive on-the-job stress, fears of becoming infected, and grief over seeing patients succumb to COVID-19 while isolated from their families.
New evidence gathered by the International Council of Nurses (ICN) suggests COVID-19 is causing mass trauma among the world’s nurses. The number of confirmed nurse deaths now exceeds 2,200, and with high levels of infections in the nursing workforce continuing, overstretched staff are experiencing increasing psychological distress in the face of ever-increasing workloads, continued abuse and protests by anti-vaccinators.
However, other small silver linings that came from the pandemic include increased professional autonomy, leadership opportunities and career growth potential.
How much of the cause of burnout is due to the hospitals or healthcare providers, and what can they do to address it?
Nurse fatigue poses serious problems for healthcare organisations, and a recent survey from Kronos found 63% of nurses say their job has caused burnout. The survey also found that more than 4 out of 5 nurses think hospitals today are losing good staff because other employers offer a better work/life balance.
Nurse burnout not only contributes to staff turnover, but it can impact the facility’s quality of care, patient satisfaction, and even medical outcomes.
Strategies to address burnout include training improving nurse-to-patient ratios, include nurses in policy discussions, and prioritise fostering a healthy work culture in hospitals.
What does your role mentoring nurses on the Incredible Health platform involve?
Rindt: My role can vary based on the needs of the nurses. The nurses love knowing they have someone in their corner who can give interview preparation advice or provide suggestions on how to improve their resume. Knowing that there is someone who is well-versed in the job process and can help set expectations on what to anticipate, really helps to remove a layer of uncertainty.
Haywood: When screening nurses, it is customised to what their individual RN or nurse practitioner needs, and at a time that is most convenient for them. Nurses are busy and often aren’t thought of first. Being able to provide support from the very beginning of their career advancement journey helps tremendously. We also provide resources such as resume templates and tips that can help nurses be successful and feel supported.