FDA Grants Priority Review to Asciminib in Newly Diagnosed Ph+ CML
Data from ASC4FIRST support the priority review designation for asciminib in Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase.
Study Aims to Address CAR T Accessibility Among Disadvantaged Groups
A retrospective study sought to assess CRS and ICANS onset and duration, as well as non-relapse mortality causes in patients infused with CAR T-cell therapies.
Survival is Similar With Mismatched vs Matched Unrelated Donors for HCT
Mismatched unrelated donor consideration may expand donor numbers, especially for those with minority ancestry seeking hematopoietic cell transplantation.
Acalabrutinib Combo Significantly Improves PFS Vs Chemoimmunotherapy in CLL
Data from AMPLIFY show a trend towards improved overall survival with acalabrutinib-based therapy among patients with chronic lymphocytic leukemia.
Breast Cancer Hormone-Modulating Therapy May Lower Risk for Dementia
Age and racial differences in subgroup analyses emphasize the need for strategies addressing Alzheimer’s/dementia risk factors and prevention of breast cancer.
FDA Approves Blood Test for Colorectal Cancer Screening
Shield, the first FDA-approved blood test for CRC screening, may offer convenient screening access for those who are at average risk for the disease.
Improving CAR T-Cell Therapy Monitoring Strategies and Access in Lymphoma
Nausheen Ahmed, MD, discusses findings from a study supporting reduced monitoring windows for patients with lymphoma who receive CAR T-cell therapy.
Radiologic Assessment May Be Used Before First Line Therapy for mccRCC
A review of patients with metastatic clear cell renal cell carcinoma shows radiological tumor burden as an independent prognostic factor for survival.
25 Treatment Patterns and Clinical Outcomes Following Endocrine Resistance Among HER2-Low Metastatic Breast Cancer Patients— Retrospective Observational Study
Ubamatamab, Anti-PD-1 ICI, May Bolster Immune Response in Kidney Cancer
A phase 2 trial is assessing ubamatamab in patients with MUC16-expressing SMARCB1-deficient renal medullary carcinoma and epithelioid sarcoma.
26 Prediction of Chemotherapy Benefit by MammaPrint® in Patients With HR+HER2- Early-Stage Breast Cancer From Real-World Evidence Studies
SON-080 May Decrease Chemotherapy-Induced Peripheral Neuropathy
The novel drug showed promise in helping to decrease chemotherapy-induced peripheral neuropathy for those who had received prior chemotherapy.
Electronic Intervention May Decrease Low-Value Surgery in Breast Cancer
A user-friendly “nudge” may provide a timely reminder to surgeons to consider the value of sentinel lymph node biopsy in older patients with breast cancer.
FDA Accepts Resubmitted BLA for Cosibelimab in Advanced Skin Cancer
The FDA has set a Prescription Drug User Fee Act date of December 28, 2024, for cosibelimab in advanced or metastatic cutaneous squamous cell carcinoma.
CBM588 May Improve Clinical Outcomes in Metastatic RCC
Analysis of 2 phase 1 trials compared gut biome diversity between standard of care with or without CBM588 in patients with metastatic renal cell carcinoma.
27 CARDIAC-STAR: Prevalence of Cardiovascular (CV) Comorbidities in Hormone Receptor–Positive/ Human Epidermal Growth Factor Receptor 2–Negative (HR+/HER2–) Metastatic Breast Cancer (mBC)
ODAC Votes in Favor of New Perioperative NSCLC Trial Design Proposals
Members agreed that perioperative regimen NSCLC trial designs should clarify the contribution of treatment during adjuvant and neoadjuvant therapy.
Ozuriftamab Vedotin Gains FDA Fast Track Designation for Recurrent SCCHN
Multiple confirmed responses in a phase 2 trial support the FDA designation for the experimental therapy in squamous cell carcinoma of the head and neck.
Creating Confidence While Climbing the Ranks in the Lymphoma Field
“Sometimes you have to be a little more assertive and a little louder, and you have to step up to the front,” Julie M. Vose, MD, MBA, said.
28 Enhancing the Interpretation of Real-World Quality of Life (QoL) in Patients With Hormone Receptor– Positive/Human Epidermal Growth Factor Receptor 2–Negative (HR+/HER2-) Advanced Breast Cancer (ABC) Enrolled in the POLARIS Trial
Novel CAR T-Cell Therapy Receives FDA RMAT Status in Advanced Thyroid Cancer
Results from a phase 1 trial evaluating the CAR T-cell therapy, AIC100, in relapsed/refractory thyroid cancer support the FDA’s RMAT designation.
FDA Accepts Resubmitted BLA for Remestemcel-L in Pediatric SR-aGVHD
The agency has set a Prescription Drug User Fee Act date of January 7, 2025, for its decision on approving remestemcel-L in this patient population.
Flexible Monitoring for CAR T-Cell Therapy May Improve Treatment Access
Following rare CRS and ICANS incidence following CAR T-cell therapy, investigators propose a reduced 2-week monitoring period with extensions as needed.
Telomere-Targeting Agent Demonstrates Tolerability in Advanced NSCLC
As of data cutoff, 6 patients with NSCLC in the phase 2 THIO-101 trial are receiving ongoing treatment with THIO plus cemiplimab after 12 months.
Nintedanib Does Not Significantly Improve PFS in Thyroid Cancer
An observed extension in progression-free survival with nintedanib vs placebo did not warrant continued development of the therapy for thyroid cancer.
FDA Gives Positive Feedback on Phase 3 Eftilagimod Alfa NSCLC Trial Design
Feedback from a Type C meeting signals the end of preparatory regulatory interactions for the phase 3 TACTI-004 trial’s design in metastatic NSCLC.
New Data Recommend Continuous Monitoring of Lymphedema for Breast Cancer
Findings from the PREVENT study show that bioimpedance spectroscopy use may reduce progression to chronic lymphedema compared with tape measure use.
Tool Combining Genomics, AI May Predict Future Prostate Cancer Recurrence
A combined genomic and histological analysis within trial datasets demonstrates a sound tumor evaluation strategy for patients with prostate cancer.
Successful/Safe Pregnancies Deemed Possible Following Allogeneic Transplant
After allogeneic hematopoietic cell transplantation, pregnancies could be carried out and were successful.
FDA Clears New Drug Application for ZW191 in FR⍺+ Ovarian Cancer, NSCLC
Preclinical data support the potential anti-tumor activity and tolerability of a novel FR⍺ topoisomerase I inhibitor in ovarian cancer and NSCLC.