Despite Similar Recurrence Scores, Black Patients With HR+ Breast Cancer Have Worse Outcomes
December 7th 2022Non-Hispanic Black patients with HR+ breast cancer experienced worse overall outcomes compared with other patient subgroups despite similar recurrence scores, according to a recent analysis of the phase 3 RxPONDER trial.
Abemaciclib Plus Endocrine Therapy Improved Survival in HR+/HER2– High-Risk Early Breast Cancer
December 7th 2022The prespecified overall survival analysis of the phase 3 monarchE trial when abemaciclib was added to endocrine therapy in patients with hormone receptor–positive, HER2-negative, node-positive early breast cancer.
FDA Grants BTD to Revumenib for Relapsed/Refractory KMT2Ar Acute Leukemia
December 6th 2022Revumenib, which was given a breakthrough therapy designation by the FDA, may be beneficial in the management of relapsed or refractory KMT2A-rearranged acute leukemia based on data from the phase 1 AUGMENT-101 trial.
Adjuvant Pembrolizumab Improves Quality-of-Life Vs Interferon α or Ipilimumab in Resected Melanoma
December 5th 2022A secondary analysis from the phase 3 SWOG S1404 trial indicated that adjuvant pembrolizumab yielded improved patient-reported outcomes compared with high-dose interferon α or ipilimumab in the treatment of patients with high-risk resected melanoma.
FDA Decides Not to Approve 131I-Omburtamab for Neuroblastoma With CNS/Leptomeningeal Metastases
December 5th 2022The FDA has followed the recommendation of its Oncologic Drugs Advisory Committee and issued a complete response letter denying approval to 131I-omburtamab as a treatment for central nervous system and leptomeningeal metastases stemming from neuroblastoma.
Pembrolizumab Remains Effective for Years in a Bladder Cancer Subset
December 5th 2022Long-term follow-up showed that the use of pembrolizumab monotherapy maintained durable complete responses, while rates of upstaging at the time of radical cystectomy were consistent with previous findings in the KEYNOTE-057 trial in patients with a bladder cancer subset.
FDA Accepts BLA for Denileukin Diftitox in Cutaneous Persistent/Recurrent T-Cell Lymphoma
December 4th 2022The FDA’s acceptance of the biologics license application for denileukin diftitox for the treatment of patients with cutaneous persistent or recurrent T-cell lymphoma was supported by data from a pivotal phase 3 trial.
FDA Grants Fast Track Designation to Novel HSF1 Pathway Inhibitor NXP800 for Ovarian Cancer
December 3rd 2022The first-in-class Heat Shock Factor 1 pathway inhibitor NXP800, the subject of an ongoing phase 1 dose-escalation study, has been granted a Fast Track designation for the treatment of platinum-resistant ovarian cancer by the FDA.
Follow-Up Data Show Tazemetostat Remains Safe, Elicits Benefit in Patients With Prostate Cancer
December 2nd 2022At a median follow-up of 17.4 months, half of the enrolled patients with metastatic castration-resistant prostate cancer experienced a decrease in PSA level from baseline following treatment with tazemetostat in combination with abiraterone acetate or enzalutamide.
Novel PSMA-TRT-based Triplet Regimen Appears Effective in Prostate Cancer
December 2nd 2022All patients with chemo-naïve metastatic castration-resistant prostate cancer experienced PSA decline, and half the cohort experienced a PSA decline greater than 50% after treatment with a novel PSMA-targeted radionuclide therapy.
PSMA Remains ‘Relevant’ But Needs to Be ‘Improved Upon’ for Treating Prostate Cancer
December 1st 2022“With more potent agents, can we actually cure patients [with prostate cancer]? I'm not so sure about that…because of heterogeneity,” said an expert from NewYork-Presbyterian – Weill Cornell Medical Center in New York City. “So we'll see. But I think with combinations, maybe someday we're going to be able to get there.”