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Michael Lai, ARNP, explained the mechanism of action of PARP inhibitors for the treatment of patients with prostate cancer.

Understanding the Mechanism of Action Behind PARP Inhibitors for Prostate Cancer

The Immune Effector Cell Encephalopathy score and keeping a close eye on patients’ symptoms are critical when monitoring for potential ICANS during lymphoma treatment.

Tools to Monitor for ICANS During Lymphoma Treatment With Bispecific Antibodies, CAR T-Cell Therapy

A multidisciplinary approach to adverse effect management addresses many needs patients with gynecologic cancers may have while undergoing treatment. 

‘Bringing Every Single Resource’ When Caring for Patients Receiving Treatment for Gynecologic Cancers

Applying diversity, equity, and inclusion to cancer clinics can help oncology nurses and APPs make an impact on patient care and research. 

Bringing DEI to Clinical Trial, Cancer Clinics Through Self-Awareness

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Kristi Rosa joined MJH Life Sciences in 2016 and has since held several positions within the company. Prior to working at the company, she served as lead copywriter and marketing coordinator at The Strand Theater. Email: krosa@onclive.com

Companion diagnostics have been approved by the FDA for olaparib plus abiraterone in patients with metastatic castration-resistant prostate cancer.

Companion Diagnostics for Olaparib Plus Abiraterone Acetate Gains FDA Approval in BRCA+ mCRPC

Adjuvant trastuzumab reveals associations with improved disease-free survival in 1-year vs 9-week administration of the drug in patients with ERBB2-positive breast cancer. 

Longer Duration of Adjuvant Trastuzumab May Further Improve DFS Rates in ERBB2-Positive Breast Cancer 

The FDA approved Boruzu, a new presentation of bortezomib, for subcutaneous or intravenous administration in patients with multiple myeloma and mantle cell lymphoma.

Bortezomib Injectable Receives FDA Approval for Multiple Myeloma and MCL

This retrospective review demonstrates the increased use of active surveillance in patients with small nonfunctional pancreatic neuroendocrine tumors. 

Active Surveillance May Benefit Certain Patients With Small Nonfunctional Pancreatic NETs

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 Beth Finley-Oliver, MSN, ARNP, AGNP-BC, a nurse practitioner who works in the outpatient hematology clinic at Moffitt Cancer Center, revisits her presentation from the 2023 JADPRO Live Annual Meeting and discusses the growing number of therapies for patients with relapsed or refractory multiple myeloma.

“A clinical trial upfront would be my first option. After that, I have to try and find something their myeloma hasn't seen yet.”

“With CAR T, the CRS incidence is higher, and I think we're doing better [at managing it] because we have multiple interventions. We see viral infections with [both] the CAR T and the bispecifics. We always have to kind of keep that in the back of our mind.”

“The more medications we have, the more this is turning into a chronic illness.”

Delivering Teclistamab in the Outpatient Setting

Ambulation Improves Frailty Scores in Patients With Multiple Myeloma

With New Bispecific Antibodies in Multiple Myeloma, Nurses Need To Know How to Manage CRS

Managing Teclistamab-Induced CRS for Patients With Multiple Myeloma

Data Supporting Elranatamab Approval in Multiple Myeloma

Data Behind Talquetamab Approval in Multiple Myeloma

Beth Faiman Discusses Recent Changes in Multiple Myeloma Treatment Landscape

ASH Data Offer Treatment Direction for Oncology Nursing Professionals

A Look Back at 2022 FDA Approvals in Oncology

Conversations Around Selinexor: Best Nursing Practices in Multiple Myeloma

Beth Finley-Oliver, MSN, ARNP, AGNP-BC, recaps part of her presentation from the 2023 JADPRO meeting about caring for patients with high-risk multiple myeloma. 

Finley-Oliver Talks Talquetamab and Other Later Line Multiple Myeloma Therapies

, Beth Faiman, PhD, CNP, weighs in on the current trajectory of research and clinical practice in multiple myeloma.

Faiman is a nurse practitioner and researcher with the Cleveland Clinic, as well as a board member of the NP/PA Center of Excellence in Multiple Myeloma. According to her, one of the biggest changes of late was the publication of a study in 

, findings of which suggest that patients with biomarker-defined defined disease, as well as 60% or more bone marrow plasma cells (BMPCs), or a free light chain ratio (FLCratio) of at least 10, have a longer time to progression and a lower 2-year progression risk than was previously believed.

Whereas the median time to progression was previously reported to be 9.2 months, the new study found the median time to be 30.1 months. Moreover the 2-year progression risk was 45.45%, rather than the previously reported 85.21%.

As Faiman points out, in 2014, the International Myeloma Working Group had added patients with at least 60% BMPCs, FLCratio equal to or greater than 100, and greater than 1 MRI-defined focal lesion of at least 5 mm (SLiM CRAB multiple myeloma) to the diagnostic category of multiple myeloma. However, this newer review suggests that this classification may need to be revisited.

Faiman also touches on shifts in approved BCMA-directed therapies for patients, namely, the accelerated approval of teclistamab-cqyv (Tecvayli) in October of 2022, and the removal of belantamab mafodotin-blmf (Blenrep) from the market in November 2022.

 She notes that there are ongoing efforts to reincorporate belantamab mafodotin into clinical practice and that she is optimistic about reintroducing this treatment back into her practice—as the dosing schedule and toxicity profile was favorable for patients. 

“Supporting [a] patient while they are in their maintenance phase [of treatment]; checking the blood counts, keeping up [with] health maintenance, making sure their bones are strong and all those other supportive care things, are so important.”

“If you have a heavily pretreated patient on some of the new cellular therapies or bispecifics, that they have to be admitted to the hospital, we have to logistically manage who’s going to be admitted on what day and when.”

“The nice thing about belantamab was that it was an [intravenous] IV [therapy] every 3 weeks, it is directed against BCMA, and it was very well tolerated.”

Hematologic Oncology Undergoes Transformation With Drug Updates and Approvals

Teclistamab-cqyv Snags Accelerated Approval for Relapsed or Refractory Multiple Myeloma

Belantamab Mafodotin Will No Longer Be Available For Multiple Myeloma

Ocular Visits Are a Necessity for Patients With Multiple Myeloma Who Receive Belantamab Mafodotin

Ludwig H, Kainz S, Schreder M, Zojer N, Hinke A. SLiM CRAB criteria revisited: temporal trends in prognosis of patients with smoldering multiple myeloma who meet the definition of ‘biomarker-defined early multiple myeloma’-a systematic review with meta-analysis. 

. 2023;58:101910. doi:10.1016/j.eclinm.2023.101910

FDA approves teclistamab-cqyv for relapsed or refractory multiple myeloma. FDA. October 25, 2022. Accessed April 10, 2023. 

GSK provides an update on Blenrep (belantamab mafodotin-blmf) US marketing authorization. News release. GlaxoSmithKline. November 22, 2022. Accessed April 10, 2023. 

Beth Faiman, PhD, CNP, discusses reclassifying patients with multiple myeloma, the accelerated approval of teclistamab, and the removal of belantamab mafodotin from the US market. 

A CRL has been issued by the FDA to the biologics license application seeking approval of linvoseltamab to treat some patients with multiple myeloma.

FDA Releases Complete Response Letter to Linvoseltamab in Relapsed/Refractory Multiple Myeloma

Donna Catamero, ANP-BC, OCN, CCRC, discusses the importance of quickly identifying and managing adverse effects from CAR T-cell therapy in patients with multiple myeloma.

Managing Adverse Effects of CAR T-Cell Therapy in Multiple Myeloma

Darzalex Faspro plus VRd was approved by the FDA for induction and consolidation in newly diagnosed multiple myeloma eligible for ASCT.

Subcutaneous Daratumumab Plus VRd Receives FDA Approval for Multiple Myeloma

Ciltacabtagene autoleucel demonstrated a statistically significant improvement in overall survival for patients with relapsed/refractory multiple myeloma refractory to lenalidomide.

Cilta-Cel Shows Promising OS Improvement in Lenalidomide-Refractory Multiple Myeloma

Bispecific antibodies like teclistamab offer “more potent” treatment than monoclonal antibodies for patients with relapsed or refractory multiple myeloma.

Long-Term Data Support Teclistamab in Relapsed, Refractory Myeloma

Bispecific antibodies like teclistamab (Tecvayli) work similarly to CAR T-cell therapies, in that they bring together myeloma cells and the T cells that will destroy them. However, bispecific antibodies are administered subcutaneously and therefore can be given without lymphodepleting regimens, explained Alfred L. Garfall, MD.

Garfall is the director of autologous hematopoietic stem cell transplantation, section chief of Myeloma, Hematology-Oncology and associate professor of Medicine at the Hospital of the University of Pennsylvania. He sat down with Oncology Nursing News at the 2024 American Society of Clinical Oncology Annual Meeting to discuss long-term follow-up from the phase 1/2 MajesTEC-1 clinical trial evaluating teclistamab in patients with relapsed or refractory multiple myeloma.

MajesTEC-1 was the longest follow-up of any bispecific antibody in multiple myeloma. Findings showed that at a median follow-up of 30.4 months, the overall response rate (ORR) was 63%, with 46.1% of patients achieving a complete response (CR) or better.

“Bispecific antibodies are…grabbing with one end of myeloma cell and the other end of the T cell and kind of pulling them together in the body,” Garfall explained in the interview. “And that is a different mechanism of immune activation than we see with conventional monoclonal antibodies like daratumumab [Darzalex], and it's essentially more potent.”

So we can think of bispecific antibodies as working in a similar fashion to CAR T cells. So bispecific antibodies are kind of grabbing with one end the myeloma cell and the other end the T cell and kind of pulling them together in the body. And that is a different mechanism of immune activation than we see with conventional monoclonal antibodies like daratumumab, and it's essentially more potent. 

So this is a way to kind of get the same engagement of the T cell arm of the immune system that we're going for with CAR T-cell therapy but with the simplicity of a subcutaneous injection that can be started without the need for all the infrastructure that's required for CAR T-cell therapy, and also without the need for things like lymphodepleting chemotherapy, which is required for CAR T-cell therapy.

Bispecific antibodies like teclistamab offer “more potent” treatment than monoclonal antibodies for patients with relapsed or refractory multiple myeloma. 

Andrea Wagner, M.S.N., RN, OCN, in an interview with Oncology Nursing News discussing her abstract on verbal orders for CRS. 

Nurse-Driven Orders May Expedite Tocilizumab Administration for CRS

Since patients experiencing cytokine release syndrome (CRS) tend to have better outcomes when administered tocilizumab (Actemra) soon after symptom onset, a group of clinicians from Hackensack Meridian Health established a nurse-driven order for the immunosuppressive drug in patients being treated with bispecific antibodies.

Findings from their intervention were presented at the 49th 

The use of bispecific antibodies for blood cancers — namely lymphoma and multiple myeloma — has grown over the last year. While these drugs are promising for the treatment of hematologic malignancies, they do come with a risk of CRS.

T-Cell Engagers Take Center Stage in Large B-Cell Lymphoma

“As a team, we decided that while tocilizumab falls under the umbrella of chemotherapy biotherapy, for which verbal orders should not be accepted per ONS guidelines and per Hackensack guidelines as well, we wanted to come up with a way that kind of still acts that way, but allows verbal orders to also be part of the workflow,” lead study author, Andrea Wagner, M.S.N., RN, OCN, an oncology clinical nurse specialist at Hackensack Meridian Health, said in an interview at the congress.

Wagner and colleagues established a system where patients consent to receiving tocilizumab upon admission for their bispecific antibody treatment. They also established a physician communication order on admission orders. This states that once it was confirmed that a patient had CRS, the nurse would be able to put in the order for tocilizumab with the proper dosing based on the patient’s weight.

With this new nurse-driven process, the majority of patients (82%) were given tocilizumab within 1 hour of the order entry — an increase from the 60% of patients who received tocilizumab within an hour after physicians or advanced practice providers placed the order entry.

“This really capitalized on getting the patient the drugs that they needed in a timely manner so we did not have any medication errors using the protocol or in general, which is good,” Wagner said.

Establishing a nurse-led system to administer tocilizumab in patients receiving bispecific antibodies tended to get the immunosuppressive drug to patients faster. 

Onc Nurse TV

Elranatamab (Elrexfio) a BCMA-CD3-directed bispecific antibody immunotherapy that is delivered subcutaneously, was granted accelerated approval on August 14, 2023, to treat patients with relapsed or refractory multiple myeloma (RRMM) who have already undergone 4 prior lines of treatment, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Of note, the new agent is the first off-the-shelf, or ready-to-use, fixed-dose subcutaneous BCMA-directed agent approved for this population that has an every-other-week dosing schedule following 24 weeks of weekly treatment.

 Elizabeth Aronson, MSN, FNP-BCN, OCN, who is a clinical nurse practitioner specializing in bone marrow transplant and immune effector cell therapies at Mount Sinai Hospital, walked through the clinical trial data supporting the approval and underscored what stood out to her about the current evidence.

The approval was supported by data from the phase 2 MagnetisMM-3 trial (NCT04649359). This single-arm trial demonstrated that patients with heavily treated RRMM (n = 97) achieved a 58% overall response rate (ORR) with treatment. Further, 82% of responders maintained a response for at least 9 months.

Additionally, long-term efficacy data presented at the 2023 European Hematology Association meeting, showcased a 61% ORR and a median duration of response, overall survival, and prepgression-free survival that had not yet been reached at 14.7 months. Investigators estimated that for the remaining patients, the probability of maintaining a response at 15 months of follow-up was 72%.

According to Aronson, MagnetisMM-3 trial is a unique trial because it allowed patients who were heavily pretreated to enroll. She explained that over 90% of patients who enrolled on the trial were triple-class refractory, meaning that they had already undergone standard-of-care drugs and yet their multiple myeloma had continued to progress. Further, she noted that many studies evaluating BCMA-directed agents do not enroll patients who have already undergone BCMA-directed therapy. However, MagnetisMM-3 did enroll patients who BCMA-targeted therapy refractory, making it different.

Finally, Aronson noted that the toxicity profile with elranatamab was comparable to other bispecific antibodies and CAR T-cell therapies approved for patients with RRMM. In the trial, most patients who developed cytokine release syndrome (CRS), and neurotoxicity had low grade reactions and the toxicities were managed with acetaminophen and tocilizumab (Actemra) supportive care, she said, noting that patients were not requiring intensive care unit admission to manage CRS.

Pfizer’s ELREXFIO™ receives U.S. FDA accelerated approval for relapsed or refractory multiple myeloma. Pfizer. Press release. August 14, 2023. Accessed September 25, 2023. 

https://www.pfizer.com/news/press-release/press-release-detail/pfizers-elrexfiotm-receives-us-fda-accelerated-approval

Elizabeth Aronson, MSN, FNP-BCN, OCN, shares what stood out to her about the phase 2 MagnetisMM-3 trial assessing elranatamab in multiple myeloma. 

Elizabeth Aronson Walks Through the Data Supporting Elranatamab Approval in Multiple Myeloma

Elizabeth Aronson, MSN, FNP-BCN, OCN, shares what stood out to her about the phase 2 MonumenTAL-1 study assessing talquetamab in multiple myeloma.

Elizabeth Aronson Breaks Down Data From Behind Talquetamab Approval in Multiple Myeloma

Talquetamab-tgsv (Talvey), a GPRC5D bispecific antibody that is delivered subcutaneously, 

received accelerated approval on August 10, 2023

, to treat patients with relapsed or refractory multiple myeloma (RRMM) who have already undergone 4 prior lines of treatment, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Data from the phase 2 MonumenTAL-1 study (NCT04634552) supported the regulatory decision, which enrolled 187 patients with heavily pretreated multiple myeloma.

 Elizabeth Aronson, MSN, FNP-BCN, OCN, who is a clinical nurse practitioner specializing in bone marrow transplant and immune effector cell therapies at Mount Sinai Hospital, 

walked through the clinical trial data supporting the approval

 and shared what stood out to her about the current evidence.

Aronson’s institution hosted a large portion of the MonumenTAL-1 study, so she already has had lots of experiencing caring for patients receiving talquetamab. She shared that her and her team are excited about this new agent, especially because it is the first approved therapy that targets GPRC5D.

As Aronson explained, talquetamab is a bispecific that is given subcutaneously. It should be administered through a step-up dosing schedule to mitigate cytokine release syndrome and other immune effector cell-associated neurotoxicity syndrome (ICANS).

The MonumenTAL-1 trial enrolled patients who were heavily pretreated, so they had already received the standard-of-care therapies and their disease had progressed. As Aronson pointed out, approximately three quarters of patients were triple-class refractory. Of note, the trial also included a cohort of patients who had undergone prior treatment with a bispecific antibody or CAR T-cell therapy, as well as a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

In the trial, patients were able to receive the therapy on either a weekly or biweekly dosing schedule. Among patients who received a biweekly subcutaneous dose of 0.8 mg/kg, the overall response rate (ORR) was 73.6% (95% CI, 63.0-82.4). At a median follow-up of nearly 6 months (range, 0-9.5), the very good partial response rate was 58% and the complete response rate was 33%.

Among patients who received therapy on a weekly schedule, the ORR was 73.0% (95% CI, 63.2-81.4). At a median follow-up of nearly 14 months (range, 0.8-15.4), the very good partial response rate was 57% and the complete response rate was 35%.

Because of the unique mechanism of action exhibited by the drug, 

patients may experience oral and dermatologic toxicities

. Nurses should be aware that besides CRS and neurotoxicity, skin and nail disorders, and oral toxicities are common. However, oral and dermatologic adverse events can be mitigated with nurse intervention.

U.S. FDA approves Talvey (talquetamab-tgvs), a first-in-class bispecific therapy for the treatment of patients with heavily pretreated multiple myeloma. News release. Janssen. August 10, 2023. Accessed August 10, 2023. 

https://www.janssen.com/us-fda-approves-talveytm-talquetamab-tgvs-first-class-bispecific-therapy-treatment-patients-heavily

Elizabeth Aronson, MSN, FNP-BCN, OCN, shares what stood out to her about the phase 2 MonumenTAL-1 study assessing talquetamab in multiple myeloma. 

The panel provides clinical advice on caring for patients with multiple myeloma who are treated with talquetamab.

Clinical Advice on Caring for Patients Treated With Talquetamab

Beth Faiman, PhD, MSN, explores how a GPRC5D-targeting bispecific antibody can benefit patients with relapsed/refractory multiple myeloma.

Integrating GPRC5D-Targeting Bispecifics for Relapsed/Refractory MM

Experts explore strategies to effectively manage toxicities associated with talquetamab in the treatment of multiple myeloma.

Multiple Myeloma

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