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.”
Despite Limitations, Oral Mobocertinib Offers Ongoing Benefits for Lung Cancer Subset, Says Expert
November 30th 2022An expert from NYU Langone in New York City recently discussed the strengths and limitations of the oral tyrosine kinase inhibitor mobocertinib in platinum-pretreated patients with EGFR exon 20 insertion+ metastatic non-small cell lung cancer.
Real-World Data Support Use of Hypomethylating Drugs in Elderly Patients With Acute Myeloid Leukemia
November 30th 2022The use of hypomethylating drugs such as azacitidine and decitabine improved outcomes for patients of advanced age with acute myeloid leukemia, according to findings from a recent retrospective study of real-world data.