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The FDA supported the advancement of roxadustat for the treatment of patients with anemia-associated lower-risk myelodys...
08/12/2025

The FDA supported the advancement of roxadustat for the treatment of patients with anemia-associated lower-risk myelodysplastic syndrome, agreeing upon important design elements for a pivotal phase 3 trial for this patient population in a Type C meeting.

https://hubs.li/Q03CfZQt0

Roxadustat’s developers intend to file the full phase 3 protocol to the FDA in the fourth quarter of 2025.

"There needs to be cross-collaboration…such that, on the hematology side, we help our oncology colleagues with the uniqu...
08/12/2025

"There needs to be cross-collaboration…such that, on the hematology side, we help our oncology colleagues with the unique toxicities. Opposite to that, the oncologists can help us understand some of the unique characteristics of a patient with solid tumors," said Zahra Mahmoudjafari, PharmD, MBA, BCOP, FHOPA.

https://hubs.li/Q03CfZzF0

| The University of Kansas Health System

The 2025 National ICE-T Symposium gave oncology experts an opportunity to share ideas regarding the administration of cellular therapies.

The FDA has accepted a new drug application for vepdegestrant for the treatment of patients with ER–positive/HER2-negati...
08/12/2025

The FDA has accepted a new drug application for vepdegestrant for the treatment of patients with ER–positive/HER2-negative, ESR1-mutant advanced or metastatic breast cancer previously treated with endocrine-based therapy.

https://hubs.li/Q03CfV6t0

"We must always be careful when using MRD as an end point because patients with high-risk disease could relapse quickly,...
08/12/2025

"We must always be careful when using MRD as an end point because patients with high-risk disease could relapse quickly, and patients with standard-risk disease and slow response might also still show some [progression] that does not reflect the risk assessment for their disease," said Shebli Atrash, MD.

https://hubs.li/Q03CfNhf0

| Levine Cancer

Shebli Atrash, MD, believes the future for treatment in multiple myeloma, as well as solid tumors and beyond, includes immune therapies.

Data from the PANOVA-3 trial may support the concomitant use of TTFields plus standard of care in solid tumors across di...
08/11/2025

Data from the PANOVA-3 trial may support the concomitant use of TTFields plus standard of care in solid tumors across different therapeutic settings.

https://hubs.li/Q03B_PsN0

Data from the PANOVA-3 trial may support the concomitant use of TTFields plus standard of care in solid tumors across different therapeutic settings.

Treatment with subcutaneous epcoritamab combined with rituximab and lenalidomide in patients with relapsed/refractory fo...
08/11/2025

Treatment with subcutaneous epcoritamab combined with rituximab and lenalidomide in patients with relapsed/refractory follicular lymphoma met both dual primary end points set in the phase 3 EPCORE FL-1 trial.

https://hubs.li/Q03B_H170

The FDA has accepted a new drug application for a new formulation of the piflufolastat F 18 injection, a PSMA PET imagin...
08/11/2025

The FDA has accepted a new drug application for a new formulation of the piflufolastat F 18 injection, a PSMA PET imaging agent.

https://hubs.li/Q03B_L-80

The new formulation should increase the batch size by approximately 50% and will offer the potential to expand access to patients in new geographic locations.

Panelists discussed the manageable safety profile of 4-drug regimens in patients with transplant-eligible multiple myelo...
08/11/2025

Panelists discussed the manageable safety profile of 4-drug regimens in patients with transplant-eligible multiple myeloma. Click the link to watch:

https://hubs.li/Q03B_zXQ0

Panelists discuss the manageable safety profile of 4-drug regimens in patients with transplant-eligible multiple myeloma, highlighting dose modifications such as weekly bortezomib and dexamethasone tapering to reduce adverse effects, alongside vigilant infection monitoring to optimize tolerability a...

The dose-response relationship was more pronounced with ipilimumab vs PD-1 inhibitors, explaining why toxicity increases...
08/10/2025

The dose-response relationship was more pronounced with ipilimumab vs PD-1 inhibitors, explaining why toxicity increases with higher ipilimumab doses while efficacy may not proportionally improve with higher PD-1 inhibitor doses.

https://hubs.ly/Q03B_rYV0

Panelists discuss how the dose-response relationship is more pronounced with ipilimumab than with PD-1 inhibitors, explaining why toxicity increases with higher ipilimumab doses while efficacy may not proportionally improve with higher PD-1 inhibitor doses.

Talquetamab shows a more favorable safety profile with lower high-grade infection rates compared with BCMA–directed bisp...
08/09/2025

Talquetamab shows a more favorable safety profile with lower high-grade infection rates compared with BCMA–directed bispecifics, although a new cerebellar toxicity signal requires monitoring.

https://hubs.ly/Q03B_qZ50

Panelists discuss how talquetamab shows a more favorable safety profile with significantly lower high-grade infection rates compared with B-cell maturation antigen (BCMA)–directed bispecifics, although a new cerebellar toxicity signal requires monitoring.

Panelists discussed the rapidly expanding ovarian cancer ADC pipeline, sequencing opportunities, and personalized treatm...
08/09/2025

Panelists discussed the rapidly expanding ovarian cancer ADC pipeline, sequencing opportunities, and personalized treatment approaches despite varying toxicity profiles.

https://hubs.ly/Q03B_rHP0

Panelists discuss how the rapidly expanding ovarian cancer ADC pipeline offers promising therapeutic options with diverse payloads targeting folate receptor alpha and HER2, providing sequencing opportunities and personalized treatment approaches despite varying toxicity profiles.

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