The FDA has approved melphalan flufenamide (Pepaxto; melflufen) plus dexamethasone for adults with multiple myeloma whose disease is refractory to 1 or more of each type of agent: proteasome inhibitor (PI), immunomodulary agent (IMiD), and anti-CD38 monoclonal antibody.

“Melphalan flufenamide is a novel and innovative therapeutic option which is active in patients with multiple myeloma who have a refractory disease, and the product has a manageable toxicity”, says Professor Ola Landgren, Chief of Myeloma Program and Leader of Experimental Therapeutics Program, Division of Hematology, Sylvester Comprehensive Cancer Center, University of Miami Health System in Miami, Florida, in a press release. “Melphalan flufenamide will complement existing treatment regimens and contribute to address the growing unmet medical need among patients with relapsed or refractory multiple myeloma.”

The approval is based on findings from the phase 2 HORIZON trial, in which melphalan flufenamde combination elicited a 23.7% overall response rate, with a median duration of response of 4.2 months. The regimen also showed activity in patients with extramedullary disease (41%).

HORIZON included 157 patients with relapsed/refractory multiple myeloma who had 2 or more prior lines of therapy, and were exposed to an IMiD and a PI and were refractory to pomalidomide (Pomalyst) and/or daratumumab (Darzalex). Participants in the study had triple-class refractory disease and/or extramedullary disease (EMD) and/or high-risk cytogenetic features. Their ECOG performance status had to fall between 0 and 2.

Patients enrolled in HORIZON were administered 40 mg of melphalan flufenamide and 40 mg of dexamethasone on day 1, and then 40 mg of dexamethasone on days 8 and 15. Patients who were 75 years or older received 20 mg of dexamethasone instead. Treatment continued in 28-day cycles until disease progression or intolerable toxicity.

“The accelerated approval of PEPAXTO in the US is an important milestone for Oncopeptides, and a major step ahead in fulfilling our mission, to bring hope to patients with difficult-to-treat hematological diseases, through innovative science,” said Marty J Duvall, Chief Executive Officer at Oncopeptides AB, in a press release. “Moving ahead, our focus is to further advance PEPAXTO. We look forward to receiving top line data from the phase 3 OCEAN-study in relapsed refractory multiple myeloma, in the second quarter. The comparative study with pomalidomide, is designed to support a future supplementary New Drug Application to expand the label.”

FDA approves Oncopeptides' PEPAXTO (melphalan flufenamide) for patients with relapsed or refractory multiple myeloma. News release. Oncopeptides AB (publ). February 26, 2021. Accessed February 26, 2021. http://cisn.co/3q2bZgq

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The FDA approved melphalan flufenamide (Pepaxto; melflufen) plus dexamethasone for adults with triple-refractory multiple myeloma.

FDA Approves Melphalan Flufenamide Combo for Triple-Refractory Myeloma

The FDA approved frontline cemiplimab-rwlc (Libtayo) monotherapy for the treatment of patients with advanced non-small cell lung cancer (NSCLC) with a PD-L1 expression of 50% or greater, according to Sanofi, the manufacturer of the PD-1 inhibitor.

To be eligible for treatment with cemiplimab-rwlc, patients must not only have high PD-L1 expression in their tumor, as determined by an FDA-approved test, but they also must have metastatic or locally advanced tumors that are not eligible for surgical resection or definitive chemoradiation. Moreover, the disease must not harbor EGFR, ALK, or ROS1 aberrations.

“Notably, Libtayo was approved based on a pivotal trial where most chemotherapy patients crossed over to Libtayo following disease progression, and that allowed for frequently underrepresented patients who had pretreated and clinically stable brain metastases, or who had locally advanced disease and were not candidates for definitive chemoradiation. This gives doctors important new data when considering Libtayo for the varied patients and situations they treat in daily clinical practice,” said Naiyer Rizvi, MD, Price Family Professor of Medicine, director of thoracic oncology, and co-director of cancer immunotherapy at Columbia University Irving Medical Center, as well as a steering committee member of the trial, in a statement.

The approval was based on findings from the phase 3 EMPOWER-Lung 1 trial, published in 

, which included 356 eligible patients who were given cemiplimab-rwlc every 3 weeks at 350 mg and a control group of 354 patients who were given chemotherapy.

Average overall survival was 22 months in the cemiplimab-rwlc arm, compared to 14 months in the chemotherapy arm. Additionally, progression-free survival, as assessed by a Blinded Independent Central Review was 6.2 months for patients receiving cemiplimab-rwlc and 5.6 months in the chemotherapy arm. More than 70% of patients on the trial crossed over to cemiplimab-rwlc after progressing on chemotherapy. The PD-1 inhibitor reduced the risk of death by 32%.

“Libtayo has demonstrated an impressive level of efficacy in advanced NSCLC with at least 50% PD-L1expression in its pivotal trial,” said Ahmet Sezer, MD, professor in the Department of Medical Oncology at Başkent University in Adana, Turkey and a trial investigator.

, a prespecified analysis in the subset of patients proven to have PD-L1 expression of at least 50%, Libtayo reduced the risk of death by 43% compared to chemotherapy. This was achieved with a greater than 70% crossover rate to Libtayo following disease progression on chemotherapy, as well as the largest population of patients with pretreated and clinically stable brain metastases among advanced NSCLC pivotal trials to date,” Sezer said.

Cemiplimab-rwlc also improved outcomes for patients whose tumors had less than 50% PD-L1, reducing risk of death by 43% in this patient population compared to chemotherapy.

“With this third approval for Libtayo, we are proud to deliver on our ambition to bring our PD-1 inhibitor to patients in need with difficult-to-treat cancers, such as advanced non-small cell lung cancer," said Peter C. Adamson, MD, global development head, oncology and pediatric innovation at Sanofi. "As the leading cause of cancer deaths globally, the need for additional therapeutic options in advanced NSCLC is clear. Libtayo allows physicians to further optimize treatment of these patients whose tumors have high expression of PD-L1. We thank all of the trial investigators, patients and their caregivers who helped make this milestone possible.”

Sanofi. FDA approves Libtayo® (cemiplimab-rwlc) monotherapy for patients with first-line advanced non-small cell lung cancer with PD-L1 expression of ≥50%. 

https://www.globenewswire.com/news-release/2021/02/22/2179862/0/en/FDA-approves-Libtayo-cemiplimab-rwlc-monotherapy-for-patients-with-first-line-advanced-non-small-cell-lung-cancer-with-PD-L1-expression-of-50.html

The FDA approved single-agent frontline cemiplimab-rwlc (Libtayo) for the treatment of patients with advanced non-small cell lung cancer (NSCLC) with a PD-L1 expression of 50% or greater.

FDA Approves Frontline Cemiplimab-rwlc for Advanced Lung Cancer

Fear of cancer recurrence is a common plight for people after they have completed cancer treatment, and recent research analyzed which patient characteristics were associated with higher rates of fear of recurrence.

 recently spoke with study author Jacqueline Galica, PhD, RN, about her findings – and what oncology nurses can do to help mitigate fear of recurrence in their patients.

 What puts oncology nurses specifically in a good role to discuss fear of recurrence with their patients?

: Nurses are often that first point of contact to the healthcare system, and we are in this really unique position of trust, and this unique relationship develops. So I envisioned that if we could clarify what are the characteristics of survivors who are most likely have highest fears of cancer recurrence, this could be used by oncology nurses who are regularly seeing these people coming back to the clinics in their follow ups. [Nurses can help by] having that recurring conversation and that assessment that goes on in those conversations. And so that's what I really was striving for – for this work to be useful for oncology nurses in in those settings.

What were your findings? Which patients and patient characteristics were at most risk to experience fear of recurrence?

We used a theory, Leventhal’s Common Sense model, which is a theory that's commonly used to understand fear of cancer recurrence. We used this to identify what could be important characteristics to look at amongst cancer survivors. We looked at a number of characteristics.

What we found was consistent with other findings: people who are younger, have higher fears of cancer recurrence. And this could be for a number of different reasons, families, etc. Those who identified as female had higher fears of cancer recurrence and those who identified as male. Interestingly, people who had been diagnosed longer – so they there was a longer duration since they were diagnosed – they had higher fears of cancer recurrence, versus people who are shorter in their in their duration. And that's really interesting, because longitudinal studies that follow people for years show there's no trend, there's no trends could be anything for fear of cancer recurrence over time, people who were continued to be followed up in this cancer survivorship clinic. So they’re coming back to the clinic years and years after they were diagnosed, had higher fears of cancer recurrence. And so we think it was those reminders of coming back to the clinic where there were their experiences, reminders of these cancer experience.

Interestingly, people's perceptions were a strong predictor of higher fear of cancer recurrence. For instance, it wasn't about people who had more symptoms, but it was people who had more symptoms that they believed or caused from their cancer or caused from their treatment, these people had higher fears of cancer recurrence. People with lower self-esteem had had higher fears of cancer recurrence. And interestingly, people who were more pessimistic, had actually a lower fear of cancer recurrence. This might be their type of coping strategy that they use; they're more likely to be more pessimistic or more likely to deny or disengage, give in to their circumstances.

What should nurses do if they identify patients who are experiencing or who are at high risk of experiencing fear of recurrence?

The first thing is to normalize that fear of cancer recurrence is a normal feeling after completing treatment for cancer. In our subsequent research, [we found that] people who've had their fear of cancer recurrence normalized [felt] liberated and that they weren't alone in this feeling. There wasn't something wrong with them with experiencing this feeling. So that is, first and foremost, to normalize. This is a normal reaction to completing cancer treatment.

But then, nurses have a very special role to provide education. This means educating: what are some symptoms to watch out for that could indicate a recurrence, when to report a symptom, who to report it to, what are some things that aren't symptoms of recurrence, but just maybe long-term symptoms or side effects from treatment. So just helping patients navigate those uncertainties can help reduce the likelihood of their fear of cancer recurrence.

Encourage patients to really engage in positive coping, stress reducing activities. So recreational hobbies, that they enjoyed pre-cancer, yoga meditation. Also, remind patients that there will be some triggers to further fear of cancer that will trigger fear of cancer recurrence, this may be the anniversary of their diagnosis, this may be a mammogram or some sort of follow up testing. It's normal to have these feelings coming back around those milestones. And so that that awareness about that, even asking things like, “it sounds like you've been worrying a lot about this. Can you tell me more about that?”.

Encourage that dialogue – it helps further to normalizing how patients are feeling or survivors are feeling. It's making it a part of their cancer care, and it's helping people externalize some of those feelings. Yeah, I think that's one of the things that nurses can do.

Fear of cancer recurrence is a common plight for people after they have completed cancer treatment, and recent research analyzed which patient characteristics were associated with higher rates of fear of recurrence. 

Patient Perceptions, Other Factors Linked to Fear of Recurrence

Parents of pediatric patients with cancer were found to be more likely to believe misinformation about the coronavirus disease 2019 (COVID-19) than parents of children without a cancer history, according to recent research published in 

This puts oncology nurses in the prime position to talk with caregivers of pediatric patients, and show them where to find reliable information on COVID-19.

The researchers surveyed 735 parents of children between the ages of 2 and 17 – 315 parents had children who were currently in cancer treatment, while 420 had children without a cancer history. In the survey, participants were asked to rate COVID-19 information based on whether they thought it was “definitely untrue,” “likely untrue,” “not sure if untrue/true,” “likely true,” and “definitely true.” The survey included 17 common and untrue COVID-19 myths from the World Health Organization’s website.

“For the correct pieces of information, there was no difference between the parents of kids with cancer and the parent control group,” said Jeanine P.D. Guidry, PhD, assistant professor at the Virginia Commonwealth University Robertson School of Media and Culture and director of the Media+Health Lab said in an interview with 

“For the pieces of misinformation, parents of pediatric cancer patients were more likely to say, ‘this is correct information,” Guidry explained.

Eating garlic can help prevent infection with the COVID-19 virus

Gargling with or swallowing bleach will help get rid of COVID-19

Drinking a sip of water every 15 minutes can prevent COVID-19

While eating garlic or drinking water every 15 minutes are not unhealthy actions, they can become harmful if a person believes that they are protected from COVID-19 and, as a result, does not follow CDC guidelines. Drinking bleach, however, is outright dangerous, Guidry said.

Guidry explained that parents of pediatric patients with cancer already are experiencing the stress of a diagnosis, and as a result may be more included to believe in quick fixes to mitigate the anxiety of COVID-19.

Study findings supported this: Those who reported that they were more stressed were also more likely to believe misinformation about COVID-19.

“For people who are already in a very stressful situation in their lives, [the COVID-19 pandemic] just adds to it,” she said. “And the desire to see things resolved and to not have this additional level of uncertainty may make people more vulnerable to believing misinformation, because it gives a sense of reassurance.”

The development of COVID-19 vaccines is another area that is abound with myths and misinformation around it.

“I think one of the areas with misinformation that we have to be really careful of is, of course, misinformation related to the vaccine. We have a way out of this pandemic,” Guidry said, explaining that the high efficacy rates seen with the FDA-approved vaccines are very exciting.

“This is a better outcome vaccine-wise than we thought we would get. But that doesn’t mean anything if the vaccinations don’t get in people’s arms.”

Guidry said that some vaccine misconceptions are easier to dispel. For example, if a person is worried that it was not studied enough or corners were cut in the quick development process, they can be given scientific literature to read. But other theories – like powerful people putting microchips in the vaccine to track us – might be a bit harder to approach.

“Misinformation really just plays into our fears,” Guidry said.

Oncology Nurses Can Promote Reliable Info

Since oncology nurses are typically on the frontlines of communication with patients and their caregivers, they are in an ideal spot to talk about COVID-19 misinformation and how it can be harmful – especially in more vulnerable populations like children with cancer.

“Being aware that this is an issue is probably the biggest thing,” Guidry said. “People may be more vulnerable; keep an eye on that. Talk to them about preventative measures, talk to them about the vaccine. Right now, we’re not vaccinating children, but we are vaccinating parents.”

On a broader level, Guidry concluded, “If there’s 1 thing I would wish for our society, it’s a greater trust in science. It’s not perfect, but it’s the best we have.”

Guidry J, Miller CA, Ksinan AJ, et al. COVID-19–Related Misinformation among Parents of Patients with Pediatric Cancer. 

. 2021;27(2):650-652. doi:10.3201/eid2702.203285.

Parents of pediatric patients with cancer were more likely to believe COVID-19 misinformation than parents of children without cancer. 

COVID-19 Misinformation: Parents of Patients May Fall for It 

Patients with metastatic urothelial carcinoma (mUC) who had a higher tumor mutational burden (TMB) tended to have more immune-related adverse events (irAEs) than those with low TMB. Additionally, high TMB and irAEs rates were associated with better response rates with immunotherapy, according to recent research presented at the 2021 Genitourinary Cancers Symposium.

“It has been shown previously in the literature that TMB serves as a candidate biomarker of clinical outcomes from immune checkpoint inhibitors in urothelial carcinoma. In addition, the immune-related adverse events have been associated with a better [immune checkpoint inhibition] efficacy in multiple cancers,” said study author Elie W. Akl, MD, of the Dana-Farber Cancer Institute.

“So, we hypothesized that the immune response against new antigens is partly responsible for [irAEs] and investigated the association between [irAEs] and TMB and response to [immune checkpoint inhibition].”

The study involved 101 patients with mUC who were being treated with immune checkpoint inhibition (either single-agent or combination) at the Dana-Farber Cancer Institute.

About a third of patients (32%) reported irAEs. Six patients had grade 1 irAEs, 20 patients had grade 2, and 6 patients had grade 3. Those who experienced irAEs had a higher average TMB (15.4/mb) than those without irAEs (9.8/mb). Notably, the cutoff for TMB-high was 10/mb (non-synonymous exonic mutations per megabase).

Ninety-four patients had radiological data available at the time of the study. Among them, 50% of patients with irAEs responded, to therapy, compared to only 16% of patients without irAEs (

“However, when both adverse events and response were included in the multivariable regression, the association between adverse events and TMB was not significant,” Akl explained.

Patients who experienced an irAE and had a high TMB had an overall response rate of 56%, about double the rate of patients who had an irAE but low TMB, at 28.6%. That finding was statistically significant. A total of 21.2% of patients with high TMB but no irAE responded, and 10.3% of patients with low TMB and no irAE responded.

The researchers did not find any correlation between TMB and grading of irAE.

Looking ahead, Akl said the further research is warranted to better understand the associations between TMB, irAEs, and immunotherapy response.

“Further evaluation in metastatic urothelial carcinoma is needed to confirm this relationship between TMB adverse events and response, a larger cohort and explore specific mutations signature that may be associated with immune-related adverse events,” he said.

Patients with metastatic urothelial carcinoma with higher tumor mutational burden and who experienced immune-related adverse events tended to have higher response rates to immune checkpoint inhibitor. 

High TMB, Adverse Events May Predict Immunotherapy Response in mUC 

Health care providers are facing an increasing amount of stress due to the COVID-19 pandemic, but there are certain factors that may make some people at a higher risk for distress than others. In this episode of “The Vitals,” we spoke to Fuschia Sirois, PhD, BSc, SFHEA, reader in social and health psychology at the University of Sheffield in the United Kingdom.

Sirois analyzed clinician stress not only during the COVID-19 pandemic, but during other infectious outbreaks as well. Her research noted which groups of clinicians had higher rates of poor mental health during the pandemic, as well as which factors help to build resiliency.

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Clinician Distress: Know Your Risks

The coronavirus disease 2019 (COVID-19) pandemic has increased symptom burden – including anxiety and depression rates – in patients with cancer, according to ongoing research presented at the National Institute of Nursing Research’s Symptom Science Advances in Oncology Nursing virtual event.

“Oncology patients, during COVID-19, are experiencing a very high symptom burden,” study author Christine Miaskowski, PhD, RN, FAAN, Sharon A. Lamb Endowed Chair in Physiological Nursing and professor in the department of physiological nursing at the UCSF Helen Diller Family Comprehensive Cancer Center, said during her presentation.

More than 600 cancer survivors completed an online survey about symptom burden, which were compared to statistics from patients before the COVID-19 pandemic and the general population. The majority were female; 40% were on active treatment; about 25% lived alone; and a third had metastatic disease.

“The general population is experiencing a high amount of stress during the COVID-19 pandemic,” Miaskowski said. “So in some ways, we’re adding insult to injury. There’s a large [body] of literature on the fact that a cancer diagnosis itself and treatment is stressful for patients. And now we add these stressors in the context of COVID-19.”

Before COVID-19, about 15% to 30% of cancer survivors reported high depression scores (indicated by a score of 16% or higher per the Center for Epidemiological Studies scale). This number increased to 40.7% during the pandemic, which was also higher than the general population, which had a 33.7% rate of depression.

Trait- and state-related anxiety rates also increased in cancer survivors during the COVID-19 pandemic, increasing from 30% and 50%, respectively, prior to the pandemic, increasing to 58.3% and 48.4% after. In the general population, there was a 31.9% rate of anxiety during the COVID-19 pandemic.

When it came to sleep disturbances, more than twice the amount of patients with cancer experienced the symptom (61.4%) compared to those without a cancer history (18%-30%) during the COVID-19 pandemic.

Additionally, many patients reported feelings of loneliness as a result of social isolation. Considering that the bulk of the participants in the study were White, educated, and finished with active treatment, Miaskowski noted her concerns for those in more vulnerable populations and what they may be going through.

“I have a long list of questions about what’s happening to other groups of individuals who are less fortunate,” she said.

Moving forward, Miaskowski encouraged oncology nurses to talk to their patients about symptom burden and loneliness – during the pandemic and beyond.

“I’m going to pressure the clinicians in the room that we need to assess for stress and types of stressors. I think in some cases, it might just be enough to acknowledge that the patient is experiencing stress,” she said. “I know these conversations take time, but I think in the era of COVID-19, the vaccine administration, and post-COVID-19, we need to think about who can have these conversations and when.”

The COVID-19 pandemic increased rates of stress in the general public, adding to that of survivors who may already be feeling anxious. 

COVID-19 Amplifies Stress, Loneliness in Cancer Survivors 

Oncology nurses should discuss mental health issues with testicular cancer survivors, as recent data published in the 

 showed that this patient group is more likely to seek mental health services than their cancer-free counterparts.

The researchers analyzed 2,619 Canadian testicular cancer survivors and matched them with 13,095 individuals without a cancer history. At baseline, the 2 groups had the same rate of mental health services used.

However, in the peritreatment time period (1 month before to 1 month after orchiectomy) and the post-treatment period (1 month after treatment to end of follow-up), those with a history of testicular cancer were significantly more likely to seek an outpatient mental health service.

Participants in the study were followed for 12 years, and as time passed, the cancer survivors became even more likely to seek mental health services.

“Such persistence of mental health needs beyond the time of the diagnosis or immediate treatment (i.e. orchiectomy) suggest that the mental health concerns experienced by testicular cancer survivors are not restricted to time-limited mental health disturbances,” the authors wrote. “This also highlights that the long-term and late-effect complications of testicular cancer diagnosis and treatment extend well beyond the 5-year period during which early-stage patients are typically followed by their cancer care providers.”

Testicular cancer survivors are at an increased risk of secondary illnesses, such as cardiovascular disease, pulmonary toxicities, liver issues, neurotoxicity, and decreased fertility. While these outcomes are usually related to cancer and its treatment, the researchers found that the survivors usually sought out advice from their primary care providers, rather than their oncology team.

“The long-term mental health sequelae associated with testicular cancer, together with the fact that most visits for these problems were with family physicians and not oncologists, highlights the importance of open lines of communication between the cancer care team and primary care providers,” the researchers wrote.

Survivors who had baseline mental health treatment and/or sought out additional treatments for their testicular cancer had an increased rate in mental health service use. Since the researchers did not stratify participants by cancer stage, they cannot say if those who had adjuvant treatment for stage 1 disease had less anxiety than those who followed with surveillance.

The number of cancer survivors continues to grow, and as testicular cancer is the most common solid cancer in young adult males and had a high cure rate, understanding the long-term effects of the disease is now more important than ever.

“Accordingly, there has been an increased emphasis on understanding the long-term and late-effect treatment complications affecting testicular cancer survivors,” the researchers wrote.

Oncology nurses should be sure to talk about potential mental health issues that testicular cancer survivors may see down the road, while also maintaining open lines of communication with other members of the individual’s care team.

“Efforts to increase awareness of mental health consequences and ensure that appropriate resources and support are in place beyond the acute phase of diagnosis and treatment to support the long-term mental health of testicular cancer survivors are warranted,” the researchers wrote.

Testicular cancer survivors had a higher rate of mental health service utilization than their healthy counterparts.
 

Discuss Mental Health in Testicular Cancer Survivorship Plans

The FDA approved umbralisib (Ukoniq) for the treatment of adults with relapsed/refractory marginal zone lymphoma (MZL) who had at least 1 prior anti-CD20—based regimen; and adults with relapsed/refractory follicular lymphoma (FL) who had at least 3 prior lines of systemic therapy.

“Today’s approval of UKONIQ marks a historic day for our Company with this being our first approval and we are extremely pleased to be able to bring our novel inhibitor of PI3K-delta and CK1-epsilon to patients with relapsed/refractory MZL and FL,” said Michael S. Weiss, executive chairman and CEO of TG Therapeutics, the manufacturer of the PI3K-delta and casein kinase CK1-epsilon inhibitor.

The accelerated approval was based on the open-label, multi-center, multi-cohort UTX-TGR-205 trial, which involved 69 previously treated patients with MZL and 117 patients with follicular lymphoma who had at least 2 prior systemic therapies.

Overall response rate (ORR) was 49% in patients with MZL; 16% had a complete response. Average duration of response (DOR) was not reached for this patient group.

In patients with FL, there as a 43% ORR and 3% complete response rate. Median DOR was 11.1 months.

“Despite treatment advances, MZL and FL remain incurable diseases with limited treatment options for patients who relapse after prior therapy and no defined standard of care. With the approval of umbralisib we now have a targeted, oral, once-daily option, offering a needed treatment alternative for patients,” stated Nathan Fowler, MD, Professor of Medicine at The University of Texas MD Anderson Cancer Center and the Study Chair of the UNITY-NHL MZL &FL cohorts.

The FDA recommends that umbralisib be given at 800 mg taken orally once a day with food until the patient experiences disease progression or unacceptable toxicity.

Common adverse events (AEs), which occurred in 15% or more of patients, were: creatinine, diarrhea-colitis, fatigue, nausea, neutropenia, transaminase elevation, musculoskeletal pain, anemia, thrombocytopenia, upper respiratory tract infection, vomiting, abdominal pain, decreased appetite, and rash.

Eighteen percent of patients had severe AEs, with diarrhea-colitis and infection being the most common. The most common reasons for dose modifications were diarrhea-colitis and transaminase elevation.

The prescribing information provides warnings and precautions for adverse reactions including infections, neutropenia, diarrhea and non-infectious colitis, hepatotoxicity, and severe cutaneous reactions.

“We want to thank the patients, physicians, nurses and clinical coordinators for their support and participation in our clinical trials, and the FDA for their collaboration throughout this process. We remain dedicated to patients with B-cell diseases and our mission of developing treatment options for those in need,” Weiss said.


The FDA approved umbralisib (Ukoniq) for the treatment of adults with relapsed/refractory marginal zone lymphoma (MZL) who had at least 1 prior anti-CD20&mdash;based regimen; and adults with relapsed/refractory follicular lymphoma (FL) who had at least 3 prior lines of systemic therapy.
 

FDA Approves Umbralisib for Relapsed/Refractory MZL and FL

Oncology nurses are an instrumental part of the cancer care team, and this year on World Cancer Day (Feb. 4, 2021), the Union for International Cancer Control (UICC) is giving thanks to the nurses, doctors, researchers, volunteers, advocates, and caregivers who navigated unprecedented difficulties over the last year to improve the lives and outcomes of patients with cancer.

The theme of this year’s World Cancer Day is “I am and I will,” highlighting the strength of the global cancer community in the wake of the coronavirus disease 2019 (COVID-19) pandemic.

While clinicians continue to overcome barriers, pressing issues in the cancer space remain, from limited funding for cancer centers, to inadequate cancer care in low- and middle-income countries, which make up for about 70% of cancer-related deaths. The UICC is hoping that people will 

, today and beyond, by spreading awareness, showing up to or creating events to benefit cancer research and treatment, and advocating for action.

In light of World Cancer Day, we asked oncology nurses why they chose their career path, and what the cancer community means to them.

Oncology Nursing: An Unanticipated Career

Penny Daugherty, MS, RN, OCN, ONN-CG wasn’t sure what kind of setting she wanted to go into when she was in nursing school, but on her first day of rotation on the oncology unit, she knew she had found her home. She helped to comfort a man in his final moments — an experience that was very meaningful to her.

“To be entrusted with the care of patients (and their families) in the terrifying experience of a cancer diagnosis is quite an opportunity to use every skill we used in nursing school,” Daugherty told 

. “To be able to guide them through treatments, side effects, and hopefully the restoration of genuine quality in their lives is a unique blessing and privilege that I am humbled by each day I have practices as an oncology nurse, and now an oncology nurse navigator.”

Lea Ann Biafora, MS, RN, OCN, CCM, ONN-CG, also fell in love with oncology nursing during clinical rotations — though she originally intended to work on the neonatal intensive care unit. On her last rotation on the cancer unit, she met a young woman with myeloma who had multiple fractures and was bedbound. The patient, crying, said that she did not feel clean and had not had a bath or shower in days. Biafora teamed up with other nursing students and found a way to bathe her and wash her hair.

“This experience gave her so much joy, while providing her some dignity. I loved the ability to provide compassionate care while being challenged by the complexity of cancer care. I loved the scientific approach to diagnostic and treatment processes requiring preciseness working with a multidisciplinary team while helping patients deal with the multidimensional components of cancer care. It all had me sold!  I immediately changed my plans and started working as a staff nurse on a general oncology floor at a community hospital - I have never looked back,” Biafora said.

Similarly, Emily Beard, RN, OCN, GBCN, had other nursing career plans, but from her experience as a student nurse, she said, “One week caring for people with cancer, and I was hooked.”

“I am grateful for long-term relationships with patients I have navigated over a long period, I look forward to seeing them after treatment getting back to what is most important in their lives,” Beard said.

COVID-19 Provides ‘Intense and Humble Pride’  

The COVID-19 pandemic has touched nearly every aspect of the world, and cancer care is not immune. However, oncology nurses’ dedication to patients has not waivered.

“COVID-19 has changed our world… but it only intensified our intrinsic values as nurses and the need to be the very best for each patient we are chosen to care for,” Daugherty said. “Even though COVID-19 has been a harrowing experience for all of us in the health care profession, it has given me intense and humble pride to be a nurse.”

Beard echoed those sentiments, saying that now more than ever it is important for patients who are ill to feel connected, especially as social distancing measures are forcing people to stay apart.

“To be able to give a smile via zoom to a support group participant or take a call from a family member who is worried, or give a socially distanced thumbs up to a patient leaving the clinic after chemo, these human connections of care are what keep us all going,” she said.  

“Being an Oncology Nurse during the COVID pandemic certainly has been challenging. However, helping patients cope with isolation, novel treatments and fear of the unknown has always been part of oncology nursing. Our special skill set has been an advantage during the pandemic, and will continue to serve us well as we all navigate our patients (and ourselves) through unchartered territories,” said Phyllis McKiernan, APN, MSN, OCN.

Hear from other oncology nurses on what their career means to them, and how they overcame challenges in the last year.
 

Brielle Benyon