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This week in oncology news, we saw a few decisions from the Food and Drug Administration, ranging from the agency agreeing to review a drug and potentially grant it a full approval to their citing manufacturing concerns for a gastric cancer drug.

Additionally, a small study showed 100% disease control rate in a subtype of non-Hodgkin lymphoma, and a clinical evaluation of a new prostate cancer drug will continue to enroll patients.

FDA Accepts sBLA For Tivdak in Recurrent or Metastatic Cervical Cancer

The Food and Drug Administration has accepted a supplemental Biologics License Application (sBLA) to Tivdak for the treatment of patients with recurrent or metastatic cervical cancer that has progressed after first-line therapy. Tivdak, the first antibody-drug conjugate for this patient population, received accelerated approval in 2021. Now, the sBLA is for the continued approval, which is contingent upon clinical benefit verification in confirmatory trials.

Results from the phase 3 innovaTV 301 trial presented at the 2023 ESMO Congress demonstrated that Tivdak reduced the risk of death by 30% compared to chemotherapy as a second- or third-line treatment for this patient population. The trial also showed improvements in overall survival, progression-free survival, and confirmed objective response rate. Treatment-related side effects were observed in a majority of patients, with anemia and nausea being the most common.

The FDA plans on making a decision on the approval by May 9, 2024.

FDA Cites Manufacturing Concerns in Missed Gastric Cancer Drug Deadline

Also in FDA news from the week, the agency will not meet the Jan. 12, 2024, deadline for approving zolbetuximab, a drug designed for the treatment of unresectable or metastatic HER2-negative, CLDN 18.2-positive gastric or gastroesophageal junction adenocarcinoma.

The FDA attributed the delay to "unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility" and issued a complete response letter to Astellas, clarifying that no clinical concerns, including safety and efficacy, were identified.

Zolbetuximab, a monoclonal antibody targeting the CLDN 18.2 protein overexpressed in certain gastric cancers, has shown promise in preclinical studies by inducing cell death in cancer cells. The drug had received a priority review from the FDA based on positive outcomes in the phase 3 SPOTLIGHT clinical trial and the GLOW clinical trial. Astellas, the manufacturer of the drug, is now collaborating with the FDA and the third-party manufacturer to address the identified issues and establish a timeline for resolving them.

Enrollment Continues in Study Evaluating ONCT-534 For Advanced Prostate Cancer

Patients are still being enrolled in an assessment of the novel drug, ONCT-534, for the treatment of advanced prostate cancer that has relapsed or is refractory to approved androgen receptor pathway inhibitors (ARPIs).

The study's first two cohorts received daily oral doses of 40 mg and 80 mg of ONCT-534, while the third and fourth patients, part of the third cohort, will be administered a 160 mg daily oral dose.

The ongoing phase 1/2 ONCT-534-101 study aims to determine the drug's safety, tolerability and preliminary antitumor activity, with a total of 27 patients in the first phase and two cohorts of 16 patients each in the second phase.

The study is anticipated to conclude in January 2028.

Novel Drug Shows 100% Disease Control Rate in WM

And finally, a novel drug, iopofosine I 131, showed a 100% disease control rate in patients with Waldenstrom’s macroglobulinemia, according to topline findings from the CLOVER WaM study.

The CLOVER WaM trial investigated iopofosine I 131 in 50 WM patients who had undergone at least two prior lines of therapy, including a BTK inhibitor. In an efficacy evaluable population of 41 patients who received a total dose of 60 mCi 60 or more days ago, the trial met its primary endpoint with a major response rate of 61%. The overall response rate in evaluable patients was 75.6%, with 100% experiencing disease control and 76% not experiencing disease progression at an average follow-up of eight months. Notably, 8% of patients achieved a stringent complete remission.

Now we should note, however, that this is a small study sample size of only 50 patients, so we would expect to see future studies evaluating this drug in a larger patient population.

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

Last week, the FDA provided updates on two cancer therapies. In this episode, we discuss those decisions and more. 

FDA Gives Cancer Drug Updates, Prostate Cancer Trial Enrolls Patients 

 Talks Cancer” podcast, we spoke with Dr. Asher Chanan-Khan about the current standards of care for Waldenstrom macroglobulinemia, also known as WM.

WM is a rare, incurable disease. Its current standards of care available consist of Rituxan (rituximab), Imbruvica (ibrutinib) combinations or monotherapy in the first- and second-line setting. However, there are no treatments currently approved for the third line.

Chanan-Khan discussed these options, as well as a novel agent, CLR 131, that is being evaluated in a phase 2 study.

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

In this episode of the “CURE Talks Cancer” podcast, we spoke with Dr. Asher Chanan-Khan about current standards of care for Waldenstrom macroglobulinemia, as well as a clinical trial looking at a novel therapy.

Treating Waldenstrom’s Macroglobulinemia

At age 19, I was a medical student with big dreams — until stage 4 blood cancer changed everything, leading to a journey of resilience and quiet hope.

This Wasn't the Plan: When the World Shifted After Cancer

CAR T-cell therapy may cure up to 40% of patients with lymphoma and is an option for those who can’t receive transplants, says Dr. André Goy.

CAR T Transforms Treatment Landscape for Blood Cancers

Iopofosine-131 received FDA breakthrough status for relapsed or refractory Waldenstrom macroglobulinemia, showing strong response rates in early trials.

Iopofosine-131 Earns FDA Breakthrough for Waldenstrom Macroglobulinemia

Education and patient advocacy are essential to improving care in Waldenström macroglobulinemia amid clinical advances, according to Dr. Shirley D'Sa.

Improving Education and Advocacy in Waldenström Macroglobulinemia 

Bispecific antibodies target specific cells, offering effective treatment for relapsed/refractory multiple myeloma, with varying side effect profiles.

Understanding the Use of Bispecific Antibodies in Multiple Myeloma

Valarie Traynham discusses some of ways her life has changed since being diagnoses with cancer, and what parts of her identity have remained the same.

Living With Intention After a Cancer Diagnosis

A cancer diagnosis alters the course of a person’s life, something that Valarie Traynham, a cancer thriver and patient advocate, is no stranger to following her cancer diagnoses of both breast cancer and multiple myeloma.

She says that from her diagnosis to now, her life has shifted from a from a focus on survival to a focus on living with more intention. This experience, for Traynham in particular, has shifted her focuses to now being more mindful of how exactly she spends her time, protecting her peace and saying no when needed. However, she cites one of her biggest changes as her sense of purpose that she has garnered through patient advocacy.

To delve further into this topic, CURE sat down for an interview with Traynham to discuss how her diagnosis has altered the way she lives everyday life. She ends the conversation by reinforcing that though she has changed both emotionally and physically, her core identity remains grounded in faith, community and her desire to help others.

What are some of the most significant ways your life has changed since treatment, and what parts of your identity or daily routine have remained the same?

Looking back on my journey with myeloma and breast cancer, life has shifted in significant ways. Initially, it was about mere survival — getting through the shock of not one, but two diagnoses, and enduring the treatments. Everything seemed to come at once, very fast. However, over time, I've noticed that it has become more about how I live.

I've learned to be more intentional with my time; with the things I say yes to and the things I say no to. My "no" muscle has become very strong, and I've also learned to protect my peace. I no longer take things for granted; again, it goes back to being intentional. But I think one of the biggest changes I've found on this cancer journey is that I've discovered my purpose. What started as figuring out how to navigate my own diagnosis has truly turned into a deeper commitment to helping others do the same. My advocacy work has allowed me to take everything I've experienced and turn it around to give back and help others.

At the same time, parts of my life haven't changed. My faith, for instance, remains my strong foundation; it's what keeps me going every day. I still find strength in my community, and I still enjoy showing up for others, being there to help them in their time of need. While this journey has changed me, it hasn't altered me to the core of who I really am. Instead, it has allowed me to be part of something bigger, stretched my faith, and enabled me to make connections that have totally changed my life.

Transcript has been edited for clarity and conciseness.

For more news on cancer updates, research and education,

don’t forget to subscribe to CURE®’s newsletters here.

Mark Daniels, 83, credits CAR T-cell therapy and compassionate care for helping him overcome lymphoma and endure the isolating treatment toll.

A Veteran Reflects on CAR T-Cell Therapy and Isolation

Mark Daniels, an 83-year-old veteran, pilot and gym enthusiast, has faced lymphoma twice and credits CAR T-cell therapy with saving his life.

In the video, Daniels shares how he approached the unknowns of CAR T-cell therapy with the same rigor he brought to flying Navy fighter jets and commercial aircraft. “You don’t go into something that complex without understanding it,” he says. He recalls the 

 and the care team at John Theurer Cancer Center, Hackensack Meridian Health, including a head nurse who took time to explain the treatment in detail.

Goy serves as physician in chief of Oncology Care Transformation Services at Hackensack Meridian Health. He is also chairman and chief physician officer of John Theurer Cancer Center and leads the lymphoma division at the center’s location within Hackensack University Medical Center.

Daniels describes the physical and emotional toll of CAR T, especially the isolation: “It’s kind of like being in solitary.”

Despite this, he goes on to emphasizes the professionalism and compassion of every nurse he encountered — more than 100, by his count — as a critical part of his experience.

Now in remission, Daniels remains grateful for the science and the people who guided him through.

What was your experience like with CAR T-cell therapy, and how did you stay positive through its challenges?

Well, first of all, one of the things about approaching something scary is that you don’t have all the knowledge. You have to gather information — find out what exactly they’re going to do, what it’s designed to do, how it works, what the prognosis is, what the chances are. I think Hackensack does a terrific job with that.

I expressed my reservations to Dr. Goy about the whole thing — I just didn’t understand it. And again, maybe as an aside, going back, you don’t strap into a Navy fighter jet and go flying unless you understand everything that’s going on. It can be very deadly if you don’t have all your ducks in a row. Same with commercial airline flying. Every six months, they send you to a simulator where they set engines on fire, break pressurization — all kinds of things. You have to be prepared.

Well, going into something like CAR T, I didn’t even know what it stood for. You hear ‘CAR T’ and — total blank. Dr. Goy arranged for the head nurse to come and talk to me. She was such a nice lady. She didn’t come in with the attitude of “I’ve got 10 minutes, what do you want to know?” It was more like, “I’m here — ask me questions.” And she told me the what, why, how, when, where — everything. That puts you at ease. And then, you just go through it. You suck it up.

You know it’s not going to be fun. Nothing is — whether you're getting your tonsils out, your tooth pulled, or you have a broken ankle — it’s not fun. It’s not something you say, “Oh, what are we doing this weekend? Let’s go get CAR T.” It’s not like that. But because you understand it, and because you have every confidence in the professionals...

And as an aside, I have to say: through all of this, I probably interacted with easily over 100 different nurses. Every single one of them, without exception, was knowledgeable, competent, and compassionate. They really interacted with you.

When you’re going through CAR T, you’re kind of isolated. I said to someone, it’s kind of like being in prison—like when you’re a bad prisoner, and they put you in solitary. That’s kind of what CAR T is. You’re in solitary. Usually, the only person you see is one nurse, and she’s wearing a mask, gloves, gown — all of that. That part, I think, was the hardest: the isolation. The days seemed like weeks.

Waldenstrom macroglobulinemia is often slow growing, with high survival but lower quality of life over time, explained researcher Alisha Kimble.

What Patients Should Know About Living With WM and the Road Ahead 

Patients with Waldenstrom macroglobulinemia (WM) should understand that this disease is typically slow growing, meaning many patients may not have symptoms for years before needing treatment, explained Alisha Kimble, senior outcomes researcher at Ontada.

This makes WM difficult to detect early, Kimble noted, which is why continued research is crucial — not only to improve detection but also to gather enough data for meaningful analysis.

Kimble also highlighted that survival rates for WM are relatively high. Her study identified a five-year survival rate of about 78%, which is consistent with established estimates from other sources. However, she emphasized that although survival is favorable, many patients experience lower quality of life over time due to chronic disease-related issues.

What do patients with WM need to know about the natural course of this disease?

Typically, this disease is indolent in nature, meaning that patients are often asymptomatic. They may not experience symptoms for the first few years before actually receiving treatment. This makes it difficult to identify, which is why research in this area is so important — not only because it’s hard to detect, but also because identifying enough patients to provide statistical power for analysis is challenging. That’s what brings a lot of value to this research.

Some other key things for patients to know: with this disease, survival rates are relatively high. We identified a five-year survival rate of about 78%, which aligns with SEER estimates from the American Cancer Society, and WHO estimates around 76%, making it higher than for some other rare diseases. However, these patients typically experience a lower quality of life due to chronic conditions over time, which can offset that survival advantage.

Another important point for patients is the use of risk prognostic tools. For Waldenstrom, there’s the Revised International Prognostic Scoring System, as well as a modified version. Both are risk calculators that use lab values to assess disease severity. If patients undergo this risk assessment early in their care, it can help physicians better predict outcomes and guide treatment planning.

Dr. Neha Mehta-Shah discusses ways patients with rare blood cancers, such as lymphoma, can better understand their specific subtype of disease.

Breaking Down the Stigma and How to Better Understand Rare Blood CancersDr. Neha Mehta-Shah discusses ways patients with rare blood cancers, such as lymphoma, can better understand their specific subtype of disease.

Although being dosed with cancer can oftentimes generate feelings of isolation and loneliness, being diagnosed with a rare cancer brings these feelings along with the difficulty of accessing information on the rare cancer. However, despite these feelings, patients are not alone, according to Dr. Neha Mehta-Shah who says that there are millions of people currently living with rare diseases.

To better understand the topic of rare diseases, like rare cancers, Mehta-Shah sat down for an interview with CURE, where she focused on the topic of rare blood cancers, such as lymphoma. She also discussed initial steps she recommends to help patients better understand their specific subtype, as well as how to help them feel more grounded during the early, uncertain days of their diagnoses.

Mehta-Shah is an associate professor in the Division of Oncology at Washington University School of Medicine in Saint Louis, Missouri.

You know, lymphomas are relatively uncommon types of cancers to begin with, and the term lymphoma actually encompasses over 100 different diseases. So, each of those diseases is quite rare overall compared to some of the more common types of cancer that we encounter, like breast cancer, prostate cancer, or lung cancer.

Consequently, I think most patients who have lymphoma feel emotionally that they are dealing with a rare diagnosis, and some patients are truly dealing with ultra-rare diagnoses, which can make it really hard to figure out how to navigate their experience, how to arrive at their diagnosis, how to identify doctors who are familiar with their diseases, and then how to get credible resources to ensure they are advocating for themselves.

For example, patients who have T-cell lymphomas, those constitute only about 10% of all non-Hodgkin's lymphomas. However, that term actually represents almost 20 different diseases. And so, you know, each of those diseases can be particularly rare.

I think some of the things that patients can do to help ground and orient themselves is, first, the Lymphoma Research Foundation does a fantastic job of providing resources for patients who have rare diseases. They have handouts written at a level that patients should be able to understand about the general overview of some of these diseases, how we approach treatment, and all of that information is really vetted and written by experts across the country. That information is highly credible and updated at least annually.

Similarly, there are certain other patient education resources available from other nonprofit organizations. Some of these include the Cutaneous Lymphoma Foundation, the Waldenstrom's Macroglobulinemia Foundation, and the Leukemia & Lymphoma Society, which present certain similar patient education or patient-facing material, as does the NCCN, the National Comprehensive Cancer Network.

This organization sets the guidelines for how to treat and diagnose these diseases, but they also have a patient-facing education section. All of these resources are really meant to help orient patients as to how to approach their diagnosis, what to expect during the course of their workup for the disease, and then what treatment options are available, as well as resources to figure out when to consider clinical trials as part of their treatment.

Breaking Down the Stigma and How to Better Understand Rare Blood Cancers

There was no evidence that CAR T directly caused secondary malignancies, despite FDA warnings, citing prior treatments as the cause, according to research.

A Study Investigates If CAR T Therapy Directly Causes Secondary Malignancies

Despite the Food and Drug Administration (FDA) requesting that approved BCMA- or CD-19-targeted CAR T-cell therapies come with a warning following reports of T-cell malignancies, including CAR-positive lymphoma, among patients who received the treatment, researchers have announced that they have found no evidence that the therapy caused secondary cancer in modified T cells.

That’s according to research published in 

 from the Perelman School of Medicine at the University of Pennsylvania and Penn Medicine’s Abramson Cancer Center.

CAR T-cell therapy, as defined by the National Cancer Institute, utilizes a patient’s T cells, part of the immune system, which are extracted, changed in a laboratory to attack cancer cells, grown in the laboratory and infused back into the patient. The treatment, according to a news release from Penn Medicine, involves the use of engineered viruses to deliver genetic instructions that enable a patient’s T cells to target and eliminate cancer cells. There is, according to the release, a risk of a cancer-associated gene mistakenly being turned on and causing unregulated growth, which is known as insertional mutagenesis.

Researchers drew on data from 783 adult and pediatric patients who received treatment with CAR T-cell therapy at Penn Medicine and Children’s Hospital of Philadelphia in clinical trials, and found 18 cases of secondary cancers, noting that there was no evidence that these cancers were caused by intentional mutagenesis. Instead, researchers cited suppression of the immune system from prior cancer treatments as the cause of the secondary cancers.

 associated with CAR T-cell therapy in Nov. 2023, and 

 to pharmaceutical companies behind CAR T-cell therapies asking that their labeling contain a warning of secondary malignancies and that patient counseling information and medication guide also mention the risk for cancers.

 study’s co-senior author, Dr. Joseph Fraietta, about the findings and what they mean for patients. Fraietta is an assistant professor of microbiology at the Perelman School of Medicine at the University of Pennsylvania.

After looking at over 38 clinical trials of cell therapies and engineered T cell therapies — not only CAR T-cell therapies — with over 2,200 years of total patient follow-up, the frequency of secondary malignancies is very low, actually. Across our trials, none of them were directly attributed to the engineered cell product. In other words, the cell product really didn't grow out and cause any issues.

I hope [the study] puts CAR T-cell therapies more into context in terms of the relative risk with other sorts of therapies as well. And notably, this is our experience at the University of Pennsylvania, although similar studies by other groups, these large safety data sets, they're coming out. But with that, there are also isolated instances of some of these products causing secondary malignancies, but they're very few and far between. I'm not sure how the FDA will look at it, because there's still a risk. However, these secondary malignancies that are directly attributed to the CAR T-cell products are infrequent.

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