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Anaplastic Thyroid Cancer: Hope Emerges Amid Widening Range of New Therapies
June 14th 2023Though scientific advances have been encouraging in the thyroid cancer space, there is much more work to be done to figure out exactly how to tailor the right therapy, or combination of therapies, for individual patients.
FDA Extends PDUFA Date for NDA of Nirogacestat for Desmoid Tumors by 3 Months
June 13th 2023The FDA has requested additional time to assess the analyses of previously submitted data from the phase 3 DeFi trial of nirogacestat in desmoid tumors, leading to an extension of the Prescription Drug User Fee Act decision date.
Brentuximab Vedotin/Nivolumab Appears Well-Tolerated in Early-Stage cHL
June 13th 2023In part C of the phase 2 SGN35-027 trial evaluating brentuximab vedotin, nivolumab, doxorubicin, and dacarbazine in patients with classical Hodgkin lymphoma, fewer than half of patients developed primarily low-grade peripheral neuropathy, and no cases of febrile neutropenia were observed.
FDA Grants Priority Review to Capivasertib/Fulvestrant for HR+ Breast Cancer
June 12th 2023Data from the phase 3 CAPItello-291 trial of capivasertib plus fulvestrant in HR-positive, HER2-negative locally advanced or metastatic breast cancer have led the FDA to grant priority review to the new drug application for the combination.
Teclistamab With Talquetamab Shows a Manageable Safety Profile in RRMM
June 12th 2023Yael Cohen, MD, discusses the main safety findings from the phase 1/2 RedirecTT-1 trial, which is evaluating the combination of teclistamab-cqyv and talquetamab for the treatment of patients with relapsed/refractory multiple myeloma.
Gilteritinib as Maintenance Shows Benefit in MRD+ FLT3-Mutant AML Post HCT
June 12th 2023In patients with FLT3-ITD–mutant acute myeloid leukemia and detectable minimal residual disease after hematopoietic stem cell transplant, treatment with gilteritinib elicited a 48% reduction vs patients without detectable MRD.
Phase 3 PhALLCON Trial of Ponatinib and Reduced-Intensity Chemo Shows Promise in Ph+ ALL
June 9th 2023Findings from the phase 3 PhALLCON trial show that ponatinib plus reduced-intensity chemotherapy could be a new standard of care for patients with Philadelphia chromosome–positive acute lymphoblastic leukemia.
Pelabresib Leads to Hematologic Response in Hydroxyurea-Refractory or Intolerant High-Risk ET
June 9th 2023Preliminary findings from arm 4 of the phase 2 MANIFEST trial show hematologic response and symptom improvement with pelabresib in high-risk essential thrombocythemia that is refractory or intolerant to hydroxyurea.
Daratumumab-Based Maintenance May Improve PFS After Auto-HCT in Relapsed MM
June 9th 2023Treatment with maintenance daratumumab, with or without pomalidomide, led to a median PFS of 28.5 months in patients with relapsed multiple myeloma after undergoing salvage autologous hematopoietic stem cell transplantation.
Acalabrutinib Added to BR Demonstrates Tolerability and Promising Efficacy in MCL
June 9th 2023The addition of acalabrutinib to bendamustine and rituximab met tolerability and safety end points in a phase 1b trial, as well as promising efficacy results in patients with either treatment-naive or relapsed/refractory mantle cell lymphoma.
FDA Lifts Partial Clinical Hold on Study of FHD-286 in R/R AML, MDS
June 8th 2023Now that the FDA has lifted the partial clinical hold on the phase 1 study of FHD-286 in patients with relapsed/refractory acute myelogenous leukemia and myelodysplastic syndrome, there are plans to initiate a trial to further assess the agent with decitabine or cytarabine.