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CURE’s childhood cancers page is a go-to resource for oncology news and updates in the world of childhood cancers Here, readers will find cancer articles, videos, podcasts, and more with expert insight into the latest treatments and research in childhood cancers.

Last week we saw some FDA approvals come through, as well as research that explored the psychosocial outcomes of individuals who survived pediatric rhabdosarcoma. And finally, we’ll discuss another cancer vaccine clinical trial that got the green light from the Food and Drug Administration.

FDA Approved Besponsa for Children With Acute Lymphoblastic Leukemia

The first FDA approval of last week was one in the pediatric cancer space. The agency approved Besponsa for children who are at least 1 year old and have relapsed or refractory CD22-positive precursor acute lymphoblastic leukemia., also known as ALL.

The approval is coming after findings from a single-arm study involving 53 children. Of which, 22 — that’s 42% — achieved a complete response from the therapy, with the median duration of complete response being 8.2 months. Additionally, the majority of patients who achieved a complete response also had minimal residual disease negativity, which indicates that there were 5% or less blasts found in the bone marrow and no cancer cells detected in the blood.

Having a new treatment option for children with ALL is particularly exciting, as ALL is one of the most common pediatric cancers, according to the American Cancer Society.

FDA Approves Opdivo Plus Chemo for Unresectable or Metastatic Bladder Cancer

Last week, the FDA also approved an immunotherapy/chemotherapy regimen for certain patients with bladder cancer. Specifically, the agency OKed Opdivo plus cisplatin and gemcitabine for the frontline treatment of adults with unresectable or metastatic urothelial carcinoma.

This approval was backed by findings from the CheckMate-901 trial, which showed that the Opdivo-chemotherapy regimen improved overall survival (which is the time patients live before death of any cause) and progression-free survival (which is the time patients live without their disease worsening) compared to those who did not receive Opdivo. The median overall survival was 21.7 months for those who received Opdivo compared to 18.9 months for those who did not, while progression-free survival was 7.9 and 7.6 months, respectively.

FDA Approves Brukinsa, Gazyva Combo for Relapsed, Refractory Follicular Lymphoma

Last week, the Food and Drug Administration also approved Brukinsa plus Gazyva for patients with relapsed or refractory follicular lymphoma after findings from the ROSEWOOD trial showed that not only did more patients respond to the two-drug treatment compared to Gazyva alone, but also at a median follow-up of 19 months, more patients were still responding compared to the Gazvya arm as well.

Rhabdomyosarcoma Survivors May Have Poor Psychological Outcomes

, found that survivors of rhabdomyosarcoma — which is a rare cancer affecting soft tissues — may face increased risk of psychological challenges, especially if they were exposed to previous radiation therapy or have a history of smoking.

Researchers examined neurocognitive impairment, emotional distress and health-related quality of life in survivors compared to their siblings. Results showed higher rates of issues like memory impairment and emotional distress among survivors, with smoking linked to poorer outcomes. The CURE® team spoke with study author, Ellen van der Plas on the findings. Here is what she had to say.

Ovarian Cancer Vaccine Trial Gets FDA Clearance to Proceed

The FDA has given the green light for a clinical trial of a vaccine designed to treat advanced ovarian cancer. Known as Innocell, this personalized therapy utilizes cells from the patient's own tumor which is inactivated via riboflavin and UV light. The drug is being manufactured at City of Hope in Los Angeles, and the trial aims to assess the vaccine's safety and effectiveness in stimulating immune response.

This is one of the many cancer vaccines being explored and developed in the oncology space. Check back on prior CURE® coverage for updates on vaccines to treat breast, lung, skin and other cancers.

For more news on cancer updates, research and education, don’t forget to 

Last week we saw some FDA approvals come through, as well as research that explored the psychosocial outcomes of individuals who survived pediatric rhabdosarcoma. 

Oncology Approvals, Psychological Outcomes for Survivors and an Ovarian Cancer Vaccine

Last week, we saw a few moving parts in the regulatory space, from new NCCN guidelines for pediatric neuroblastoma treatment to FDA Fast Tracks and Priority Reviews. Also last week, we covered research showing that a lower dose of an anti-emetic drug could have similar efficacy — and fewer side effects — than the standard, higher dose.

NCCN Guidelines Give Framework for Childhood Neuroblastoma Treatment

The National Comprehensive Cancer Network recently published guidelines for the treatment of pediatric patients with neuroblastoma. This resource is geared toward mitigating unnecessary side effects and over treatment in patients with low-risk disease, while also developing the best treatment plans for high-risk patients.

CURE® spoke with Dr. Rochelle Bagatell, professor of Pediatrics and Solid Tumor Section Chief at Children's Hospital of Philadelphia, and Chair of the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Panel for Neuroblastoma, who emphasized that while these guidelines can influence treatment strategies, conversations between patient families and clinicians and even insurance coverage, each patient’s care should be as personalized as possible.

“There may be specific cases where the nuances of a particular patient's case means that you have to adjust your thinking from what's written on those nice, clear lines,” Bagatell said. “But the general guidance about how to think about the risk of recurrence, what general type of therapy would be appropriate, how much chemotherapy when to do surgery. Those are the kinds of things that patients and families can look at and bring to their doctor and discuss.”

FDA Fast Tracks ARV-471 for Metastatic Breast Cancer

Last week the Food and Drug Administration (FDA) granted a Fast Track designation to ARV-471, a novel drug being studied for the treatment of patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer. Specifically, this indication of ARV-471 is for patients who previously underwent endocrine therapy.

Fast Track designations are given to drugs that show promise in treating serious conditions and fill an unmet need. The goal is to speed up the review and potential approval of these therapies.

ARV-471 is being studied in the phase 3 VERITAC-2 clinical trial, which is comparing ARV-471 to Faslodex in this patient population. Preclinical studies showed that the drug induced tumor shrinkage and degradation.

FDA Grants Priority Review for Alecensa in Some ALK-Positive NSCLC

Also in FDA news from last week, the agency granted a priority review to Alecensa as a postsurgical treatment for patients with early-stage ALK-positive non-small cell lung cancer.

The priority review is based off findings from the phase 3 ALINA trial, which showed that the drug led to a 76% reduction in the risk of disease recurrence or death compared with chemotherapy treatment. Findings from this study also showed that at two years, 93.8% of patients taking Alecensa experienced disease-free survival (which is the time after treatment when patients do not have symptoms of complications from their cancer), compared with 63% in the chemotherapy group. At three years, disease-free survival rates were 88.3% and 53.3%, respectively.

With the priority review, the FDA said that they plan on making an approval decision on Alecensa on or by May 22, 2023, though those dates can always change.

Lower Dose of Nausea, Vomiting Drug Controls Chemo Symptoms

Finally, research showed that a lower dose of a nausea and vomiting drug could be just as effective as the higher, standard dose when it comes to controlling chemotherapy-induced nausea and vomiting.

 found that a 2.5-milligram dose of olanzapine is not inferior (meaning it is no less effective) than a 10-milligram dose. Specifically, the researchers looked at the use of rescue medications, vomiting episodes and mild nausea over the course of 120 hours.

Notably, this lower dose can also lead to a decrease in side effects related to the drug, such as feeling of lethargy and drowsiness.

Last week, we saw a few moving parts in the regulatory space, from new NCCN guidelines for pediatric neuroblastoma treatment to FDA Fast Tracks and Priority Reviews

Guidelines for Childhood Neuroblastoma, FDA Decisions and More

The FDA is certainly staying busy as 2023 comes to a close, approving three treatments for patients with cancer last week alone.

Additionally, exciting study findings were released regarding a cancer vaccine for the treatment of melanoma.

FDA Approves Iwilfin for High-Risk Neuroblastoma in Adults and Children

The FDA approved has Iwilfin (eflornithine) for the treatment of adult and pediatric patients with high-risk neuroblastoma who have shown at least a partial response to a previous multiagent modality therapy, which includes anti-GD2 immunotherapy.

Notably, the FDA reported that this drug is the first approval of a therapy used to reduce the risk of relapse in children with high-risk neuroblastoma. Neuroblastoma, as the National Cancer Institute explained on its website, is a cancer of immature nerve cells that most typically occurs in children, and often begins in the adrenal glands.

The FDA said the major efficacy outcome measure behind the approval was event-free survival (EFS; time after treatment when cancer does not come back or worsen; disease progression), while other notable findings included overall survival (OS; length of time from diagnosis or start of treatment when a patient is still alive).

FDA Approves Welireg for Advanced Kidney Cancer Subtype

The FDA approved Welireg ((beluztifan) for patients with advanced renal cell carcinoma (RCC) who have been previously treated with a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).

The approval was based on findings from the LITESPARK-005 trial. Trial findings presented earlier this year at the European Society of Medical Oncology Annual Congress (ESMO) showed that at a median follow-up of 18.4 months, patients treated with Welireg experienced objective response rates (patients whose disease responded partially or completely to treatment) of 21.9%, compared with 3.5% among patients treated with Afinitor (everolimus), and 12-month progression-free survival (PFS; the time a patient lives without their disease spreading or worsening) rates were 33.7% on Welireg versus 17.6% with Afinitor, and 18-month PFS rates were 22.5% and 9%, respectively.

FDA Approves Padcev-Keytruda Combo in Advanced Bladder Cancer

The FDA has additionally approved Padcev (enfortumab vedotin-ejfv) plus Ketruda (pembrolizumab) for patients with locally advanced or metastatic bladder cancer. Alongside this, the FDA previously 

unable to be treated with cisplatin-containing chemotherapy

In the recent EV-302/KN-A39 trial, both OS and PFS showed significant improvements among the Padcev plus Keytruda group of patients, as the median overall survival for these patients was 31.5 months, while a cohort treated with chemotherapy experienced a median OS of 16.1 months.

Regarding progression-free survival, the median was 12.5 months for the Padcev-Keytruda combination group and 6.3 months in the chemotherapy group.

Cancer Vaccine Plus Keytruda Reduces Risk of Recurrence or Death in Melanoma

Patients with advanced-stage melanoma continue to experience reduced risk of recurrence or death following treatment with a combination of mRNA vaccine mRNA-4157 (V940), an investigational individualized neoantigen therapy (INT), and Keytruda, according to recent study findings.

The mRNA-4157 (V940) and Keytruda combination reduced the risk of recurrence or death by 49% and the risk of distant metastasis or death by 62% when compared with treatment with Keytruda alone in patients with stage 3 or 4 melanoma with high risk of recurrence following complete resection, as determined by 

 study, according to a news release from drug manufacturers Moderna and Merck.

The latest findings, from a median planned follow-up of approximately three years, build on previously announced primarily analysis data from a median planned follow-up of approximately two years which showed that the combination reduced the risk of recurrence or death by 44% and the risk of distance metastasis or death by 65% when compared with Keytruda alone.

Food and Drug Administration (FDA) granted Breakthrough Therapy Designation

 to the combination for the post-surgical treatment of patients with high-risk melanoma earlier this year.

Moderna and Merck have also announced the phase 3 INTerpath-001 (V940-001) clinical trial to evaluate the combination as an adjuvant treatment for patients with resected, high-risk stage 3B to 4 melanoma, which is currently enrolling participants, as well as a phase 3 trial for the treatment of patients with non-small cell lung cancer treated with the combination regimen.

The Food and Drug Administration recently approved treatment for some patients with neuroblastoma, kidney cancer and bladder cancer. Elsewhere, a cancer vaccine made headlines for the treatment of patients with melanoma.

FDA Approves 3 Treatments, Cancer Vaccine Shows Promise

Charlene Wexler has turned profound grief into a world of stories.

Wexler is the Chicago-based author of seven books as well as several short stories. Inspiration for what would become her 2014 debut novel, “Lori,” arrived following the loss of her son, Jeffrey, who received a diagnosis of leukemia in 1977 at the age of eight and died in 1981 at the age of 12.

“I always wrote for myself, and writing fiction is a new career. I started about 10 years ago,” said Wexler, who is now 80 years old.

“Cancer has been in our family for years: aunts, uncles, my mother, my grandfather, I had ovarian cancer, right now I have skin cancer. And we've dealt with all of them,” she explained. “And the cancer that really knocked us out was when my 8-year-old son, my firstborn, was diagnosed with leukemia. And we fought at Children's Memorial (Hospital, now known as Ann and Robert H. Lurie Children's Hospital of Chicago). We dealt with that, we fought the cancer for four and a half years before he died.

“And during that whole time, I wrote, I kept journals. And then after he died, I was devastated and (I) really couldn't get out of bed.”

“I took all my stuff together that I had been writing about him, and I wrote a story,” she said. “And I sent it to my sister who reads anything I write, who was there for me the whole time. And she said, 'This is great, but it's too devastating.' She said, 'Why don't you try again? Nobody's going to want to read this. It's just too grief ridden.'”

Former Opera Singer Shares Bone Cancer Journey in New Book

Wexler shifted her writing from the first-person to the third-person and moved from memoir into the realm of fiction.

“I found (that), my God, I could change it,” she said. “And instead of making him a boy, I made her a girl. And when I first started writing, I thought, 'I'm going to make her survive it.’ That (even though) Jeffrey didn't, I'm going to make Julie, the girl in my story, live. But then, as I started writing, I realized I wanted to add what happened to me and how I survived — and how I didn't survive in the beginning.

“And then, after I wrote the first draft, I realized the book needed more than just a child dying from leukemia. And all of a sudden, the character Lori became stronger than the child that died. And I felt like there are a lot of issues I can deal with. A third of the book deals with the cancer, and it deals with surviving afterwards.”

Also from the “Cancer Horizons” podcast: 

Mother with Stage 4 Breast Cancer and Her Family 'Focus on the Living'

For Wexler, a former teacher who also spent time working in her husband’s dental office, “Lori” became the start of the four-book Laughter and Tears series, and her work is currently being re-released via Speaking Volumes.

Wexler spoke with CURE®’s “Cancer Horizons” podcast about her cancer journeys, her path to becoming an author and the different challenges faced by patients and caregivers.

Charlene Wexler, the Chicago-based author of the Laughter and Tears series of novels, is an ovarian cancer survivor who now has skin cancer. She told CURE® about how her son’s death from leukemia led to her re-invention as a writer.

Author, Cancer Survivor Channeled Her Grief Into a Series of Books

When going through cancer treatment, “pain is a message you don’t have to listen to,” says Rabbi Elimelech Goldberg — also known as “Rabbi G” — the founder of Kids Kicking Cancer, a nonprofit that teaches children with cancer breathing techniques and martial arts to cope with the pain and stress that comes with a cancer diagnosis.

‘Profound’ Evidence Shows Breathing Can Improve Cancer-Related Pain and Stress

Goldberg, who is also a black belt in Choi Kwang Do and clinical assistant of pediatrics at Wayne State University School of Medicine in Detroit, started teaching children about breathing to manage pain in the 1980s, when his late daughter, Sara, was going through treatment for acute myeloid leukemia. After Sara’s death, Goldberg continued his teaching, established the nonprofit and traveled around the globe teaching children and adults how to use their breath to mitigate suffering. The rabbi even visited the Catholic Pope to teach breathing techniques to children in Vatican City.

The children then, in turn, go on to become the teachers.

“(Breathing) takes advantage of several elements and the role of physiology that allow the brain to say, ‘Wait a second, I’m not a victim. I’m a victor.’ That’s what these children teach in the world,” Goldberg said. “No matter what you face in your life, you can breathe in that light and breathe out darkness.”

In this episode of the “Cancer Horizons” podcast, Goldberg discusses his experiences and offers a simple breathing exercise that listeners can use to help get their stress under control.

In this episode of the “Cancer Horizons” podcast, “Rabbi G” discusses his global travels to teach breathwork to children with cancer, and gives an exercise listeners can use to decrease their pain and anxiety. 

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