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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

After many years of an extensive and fascinating career in pediatric oncology, cancer followed Dr. Michael Weiner to his own home: his daughter was diagnosed with thyroid cancer in her early 20s, and he himself received a diagnosis of follicular lymphoma.

” podcast, Weiner, who is the former chief of the division of pediatric oncology at Columbia University Irving Medical Center in New York, discusses the details of his cancer journey, how he was able to support his daughter through hers, and more.

“We tried very hard, my daughter and I, to have a daughter-father relationship, not a daughter-doctor relationship,” Weiner said. “Fortunately, there are many excellent, superb physicians at Columbia, which is where I've worked for so many years. And I knew that she was going to get excellent care, but she only had one father. And I wanted to be that person and to be there for her.”

“We tried very hard, my daughter and I, to have a daughter-father relationship, not a daughter-doctor relationship,” said Dr. Michael Weiner on this episode of the “CURE® Talks Cancer” podcast, in which he discussed his career, his own cancer journey and his daughter’s diagnosis.

When the Daughter of a Pediatric Oncologist Receives a Cancer Diagnosis

Four years after remission from follicular lymphoma, ongoing fear of relapse, lingering symptoms, and life stressors continue to weigh heavily on me.

Lingering Stress After Follicular Lymphoma Remission is a Challenge

It’s spring, a time for new beginnings following a cancer diagnosis; however, I have an ongoing issue that I can’t dismiss.

Remission is Not a Cure for Follicular Lymphoma, or Any Cancer

Life after treatment for follicular lymphoma brings long-term physical and emotional challenges, including immune system impacts and lasting social effects.

The Unseen Long-Term Effects After Follicular Lymphoma Treatment

Living with follicular lymphoma, I challenge common misconceptions about cancer, highlighting the unique and varied experiences of patients with cancer.

Challenging Cancer Stereotypes While Living with Follicular Lymphoma

My annual scan showed no cancer recurrence, but revealed some minor issues related to aging and potential fibroids, requiring monitoring and follow-up.

The Good and The Bad of Follicular Lymphoma

Dr. Deepa Jagadeesh discusses Ordspono's potential FDA approval for relapsed/refractory follicular lymphoma, highlighting its manageable toxicity and low CRS rate.

Expert Explains the Side Effects of Ordspono in R/R Follicular Lymphoma

The potential Food and Drug Administration approval of Ordspono (odronextamab) for relapsed or refractory follicular lymphoma (FL) was discussed by Dr. Deepa Jagadeesh, a hematologist and oncologist at Cleveland Clinic Main Campus. FL is a low-grade lymphoma that requires multiple treatments, but response rates typically decrease over time, she mentioned. The approval of Ordspono, a bispecific antibody with manageable toxicity and high efficacy, would offer a treatment for patients with limited options.

Jagadeesh reviewed the ELM-1 and EML-2 trials, which showed a 91% overall response rate and a 72% complete response rate in patients with relapsed/refractory FL. The safety profile showed low rates of cytokine release syndrome (CRS) following a split-dose regimen.

Jagadeesh noted that Ordspono is ideal for patients who cannot undergo CAR-T cell therapy or have failed previous treatments. Its low CRS rate and potential for fewer hospitalizations make it a possible option for improving patient quality of life.

The main side effects that we noticed with this class of drug is CRS, which we call it, cytokine release syndrome. So, this usually happens with patients — most of all the bispecific antibodies are given in a dose escalating fashion. So, patients receive a smaller dose first than a higher dose on day eight, and day 15 they get a higher dose. So, as the dose is escalated, when they get the full dose, most patients, there is a risk of experiencing CRS. So, the cytokine release syndrome presents very similar to how cytokine release syndrome happens in CAR-T patients. So, patients can have fever, they can have low blood pressure, high heart rate, and also in some patients, they may experience difficulty breathing because they're hypoxic and with low oxygen levels.

So, when these things happen, we usually tell the patients that if they are admitted in the hospital, then they will get a drug called tocilizumab [Actemra] to kind of counteract this. If patients are in the outpatient setting, we give them very specific instructions on how often do they need to check their vitals, and what are the most important things when they need to go to the nearest emergency room or to call the treating physician's office immediately when they experience these symptoms, so that they can receive the [Actemra (tocilizumab)] and treatment for this, which is very preventable from progressing.

The other most common side effect that we see is what we call ICANS, that is the immune effector cell associated neurotoxicity syndrome. So basically, that means is that the patients may experience some neurotoxicity, it can have a wide range of presentations. So, some patients may experience some confusion, some headache, and sometimes they may forget how to write a sentence or spell a word. It affects memory.

Transcript has been edited for clarity and conciseness.

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Side Effect Management

The treatment combination was found to reduce the risk of follicular lymphoma progression or death by 57%, a study has shown.

How Monjuvi Plus Revlimid, Rituxan Work to Treat Follicular Lymphoma

Among patients with relapsed or refractory follicular lymphoma (FL), the treatment combination of Monjuvi (tafasitamab-cxix) plus Revlimid (lenalidomide) and Rituxan (rituximab) has been found to result in a 57% reduction in the risk of disease progression or death when compared with placebo plus Revlimid and Rituxan, study results have shown.

Preliminary findings from the phase 3 inMIND trial were presented at the 

2024 American Society of Hematology (ASH) Annual Meeting

In the study, at a median follow-up of 14.1 months, the addition of Monjuvi to Revlimid and Rituxan resulted in what researchers described in 

 as a significantly lower risk of progression, relapse or death versus treatment with placebo, with median progression-free survival times of 22.4 months for the Monjuvi group compared with 13.9 months in the placebo group.

“In the phase 3 inMIND trial, [Monjuvi] demonstrated impressive efficacy and safety for treating certain patients with follicular lymphoma, the most common type of B-cell non-Hodgkin lymphoma,” said Dr. Steven Stein, Chief Medical Officer of Monjuvi manufacturer Incyte, in a news release issued by the company. “These data, the first to evaluate the novel approach of combining CD19 and CD20 immunotherapies, show the potential of [Monjuvi] in combination with [Revlimid] and [Rituxan] to become a new standard of care for these patients. We look forward to working with regulatory authorities to potentially bring this treatment forward to patients with FL.”

During the ASH conference, CURE® spoke with Dr. Christina Poh, a physician at the Fred Hutch Cancer Center and an assistant professor in the Division of Hematology and Oncology, University of Washington School of Medicine about how this combination works to treat cancer.

In terms of [Monjuvi] alone, [Monjuvi] is what we call an anti-CD19 monoclonal antibody. Essentially this drug targets CD19, which is a signal that is found on the surface of many of the cancer cells in the body, like follicular lymphoma. Once this drug sees CD19, it binds to it, and that stimulates the immune system to come to clear it up from the body. [Rituxan] is essentially another monoclonal antibody, but this is anti-CD20, so it does the exact same mechanism as [Monjuvi], but it targets CD20. [Revlimid] does a lot of things, but the overall thinking is it modulates the immune system to help these antibodies work better in our body.

“Tafasitamab Plus Lenalidomide and Rituximab for Relapsed or Refractory Follicular Lymphoma: Results from a Phase 3 Study (inMIND)” by Dr. Laurie H. Sehn et al., 

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CURE® spoke with an expert about follicular lymphoma, a disease that is still considered incurable.

What is Follicular Lymphoma and Why Are Better Treatments Needed?

There have been a number of advancements in the treatment of follicular lymphoma in 2024.

, the Food and Drug Administration (FDA) approved Brukinsa (zanubrutinib) plus Gazyva (obinutuzumab) for the treatment of patients with relapsed or refractory follicular lymphoma who had undergone two or more prior lines of systemic therapy. This approval was followed 

 by the FDA’s approval of Breyanzi (lisocabtagene maraleucel) for the treatment of patients with relapsed or refractory follicular lymphoma who had previously been treated with two or more lines of therapy and 

 by the agency’s granting of an accelerated approval to Epkinly (epcoritamab-bysp) for patients with relapsed or refractory follicular lymphoma who have been previously treated with two or more lines of systemic therapy.

Additionally, Monjuvi (tafasitamab) has been shown to have positive results regarding disease progression for patients with relapsed or refractory follicular lymphoma, with Monjuvi manufacturer Incyte announcing 

 that it plans to file a supplemental Biologics License Application with the FDA for Monjuvi to treat patients with follicular lymphoma who previously underwent at least one previous systemic anti-CD20 immunotherapy or chemo-immunotherapy.

During the 2024 American Society of Hematology Annual Meeting and Exposition, CURE® spoke with Dr. Christina Poh, a physician at the Fred Hutch Cancer Center and an assistant professor in the Division of Hematology and Oncology, University of Washington School of Medicine about follicular lymphoma and the need for better treatments.

The nature of follicular lymphoma lies in the underlying pathogenesis. Essentially, this is a disease that is generally indolent, so it's generally slow growing, waxing and waning, but currently with our available therapies, it's still considered incurable, and so especially for our patients who are diagnosed at a younger age, there is a need for better therapies, or more therapies that will essentially prolong, that will help get the disease under control and actually control the disease for a long time. Ideally, we want this condition, obviously, to be curable. We want to be able to cure this, but I think at the end of the day, we want to make sure that this does not harm our patients or cause complications with their daily life.

When it comes to treating follicular lymphoma, future treatment paradigms may involve harnessing a patient’s immune system to help fight cancer, according to one expert.

’s sister publication, recently spoke with Dr. Connie L. Batlevi, a medical oncologist specializing in lymphoma at Memorial Sloan Kettering Cancer Center, about the follicular lymphoma treatment landscape and adding immunotherapy to it, which has shown encouraging data of late.

In particular, Batlevi said, using the patient’s immune system to modulate the disease is of interest to clinicians. Current studies are also looking at the efficacy of CAR-T cell therapy, antibody​-drug conjugates, and bispecific antibodies, Batlevi said. Future research should also work on identifying the right sequence of therapies is going to be key for patients, she concludes.

So, in terms of novel treatments and combinations of treatments that are coming down the pipeline, I think the things are of interest are sort of using the immune system to modulate the disease course of follicular lymphoma. We have seen promising data for chimeric antigen receptor T-cells in follicular lymphoma. CAR-T cells, we've also seen some interesting data using antibody drug conjugates. We are looking at the data for specific antibodies for follicular lymphoma.

And (while) all of those are very intriguing, how to put them in context and how to how to strategize or the sequencing of those for our patients will be important in the next several years.

Follicular lymphoma treatment options are changing, and according to one expert, immunotherapy could become a major part of therapy sequencing. 

Follicular Lymphoma Treatment Could Rely on Immunotherapy in Therapy Sequencing

While the National Institute of Health reports that follicular lymphoma has a five-year relative survival rate of 89%, follicular lymphoma has the potential to become aggressive, making it harder to treat, says Dr. Kami J. Maddocks.

’s sister publication, Maddocks, an associate professor of clinical internal medicine in the Division of Hematology at The Ohio State University Comprehensive Cancer Center–James, examined the challenges that exist in treating patients with follicular lymphoma.

In particular, Maddocks noted, patients who relapse within 24 months of completing their first therapy tend to have a more aggressive disease, making it harder for oncologists to find treatments that will produce long-term results.

Follicular lymphoma that turns into aggressive, incurable lymphoma is another challenging issue, according to Maddocks. In these cases, allogeneic transplant is an option, but patients will need to be in treatment for the rest of their lives.

Probably our biggest challenge in patients with treating follicular lymphoma is those patients that we define as the early relapses. So those patients that progress within 24 months of completing their initial therapy, these patients have more aggressively behaved disease, and it's harder to get them long term responses and long-term remissions. This is the greatest challenge we face and there are ongoing trials right now looking at the best treatment for these patients.

When follicular (lymphoma) transforms to aggressive lymphoma, that also represents a challenge for patients. And then this is still you know, outside of an allogeneic transplant, which is rarely done not a curable disease. So, these are treatments, patients are going to deal with this disease on and off for the rest of their life. And so, finding effective, long-lasting and tolerable treatments is really a goal here.

Dr. Kami J. Maddocks discusses the importance of effective treatments for patients with aggressive follicular lymphoma and the treatment challenges they face.

Follicular Lymphoma

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